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					                                       IHE QRPH Domain:
                                 Drug Safety Content White Paper

Drug Safety Content
Introduction
This is a draft of the Drug Safety Content Profile (DSC) from the QRPH Domain.

Drug Safety Content .................................................................................................................. 1
Introduction ................................................................................................................................ 1
   Profile Abstract ....................................................................................................................... 2
   Glossary ................................................................................................................................. 2
   Volume I ................................................................................................................................. 3
     Dependencies ..................................................................................................................... 3
     Profile Name ....................................................................................................................... 4
     Use Cases .......................................................................................................................... 4
        Use Case – Pharmaceutical Trial .................................................................................... 4
           Current State ............................................................................................................... 4
           Desired State ............................................................................................................... 4
        Use Case – Phase IV Studies ......................................................................................... 4
           Current State ............................................................................................................... 4
           Desired State ............................................................................................................... 4
        Use Case – Post Market Surveillance ............................................................................. 4
           Current State ............................................................................................................... 5
           Desired State ............................................................................................................... 5
             ASTER Example ...................................................................................................... 5
               Workflow: .............................................................................................................. 6
        Use Case – Medication Errors ......................................................................................... 7
           Current State ............................................................................................................... 7
           Desired State ............................................................................................................... 7
        New Items to Include: ...................................................................................................... 7
           Workflow for Form........................................................................................................ 7
           Queries on Multiple Patients – Supplement to ITI – Ana Estelrich ................................ 7
           Support for Pseudonymization ..................................................................................... 7
           Section on Security for Clinical Research Data Capture –............................................ 8
        Actors/Transaction .......................................................................................................... 8
             Clinical Research Data Capture Actor Diagram ........................................................ 8
        Grouping ......................................................................................................................... 8
        Data Classes ................................................................................................................... 8
           Data Categories ........................................................................................................... 8
             Existing Standards: .................................................................................................. 8
             Data requested by FDA/regulators ........................................................................... 9
             Data requested for outcomes - definitions, mappings ............................................... 9
             Data not requested but valuable - e.g., lab studies, relevant deltas .......................... 9
             E2BM Mapping expertise - Michael Ibara ................................................................. 9
             E2BR3 Guideline update information - HL7 Ballot - Lise Stevens ............................. 9
        Content Bindings with RFD.............................................................................................. 9
     Options ............................................................................................................................... 9


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      Form Filler Options .........................................................................................................10
         CCD Option ................................................................................................................10
         Form Manager Options ...............................................................................................10
         CCD Option ................................................................................................................10
         Process Flow ..............................................................................................................10
    Actor Definitions .................................................................................................................11
    Transaction Definitions.......................................................................................................12
    Triggers .............................................................................................................................12
      Sources for triggers: .......................................................................................................12
  Volume II ...............................................................................................................................14
    Clinical Research Data Capture Content ............................................................................14
      Standards .......................................................................................................................14
      Data Element Index ........................................................................................................14
      Document Specification CDASH Option .........................................................................15
      Document Specification CCD Option ..............................................................................26
         Header Sample ...........................................................................................................27
         Active Problems Sample (1.3.6.1.4.1.19376.1.5.3.1.3.6) ............................................28
         Past Medical History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.8) ......................................28
         Procedures and Interventions Sample (1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11) ..............28
         Social History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.16) ..............................................29
         Current Medications Sample (1.3.6.1.4.1.19376.1.5.3.1.3.19) ....................................29
         Vital Signs Sample (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2) ...............................................30
         Physical Exam Sample (1.3.6.1.4.1.19376.1.5.3.1.1.9.15) ..........................................30
         Allergies and Other Adverse Reactions Sample (1.3.6.1.4.1.19376.1.5.3.1.3.13) .......33
         Coded Results Sample (1.3.6.1.4.1.19376.1.5.3.1.3.28) .............................................33
    Reference Implementation .................................................................................................34
      Clinical Research CCD to Standard CRF (ODM/CDASH) Crosswalk .............................34
      XSLT Sample .................................................................................................................35
      Sample Standard CRF output from the Sample XSLT ....................................................48


Profile Abstract
Drug Safety Content Profile (DSC)
DSC describes the content and format to be used within the Prepopulation Data transaction
described within the RFD Integration Profile. The purpose of this profile is to support a standard
set of data in CCD format which the Form Filler provides for use in reporting adverse events as it
relates to Drug Safety. In addition this profile will reference the ability to convert this output into
the ICH E2B(R3) standard.

Glossary
CCD                             ASTM/HL7 Continuity of Care Document (CCD)
Drug Safety CCD                 Refers to the CCD constrained within the Drug Safety Content (DSC)
                                profile.


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E2B(R3)                Clinical Safety Data Management: Data Elements for Transmission of
                       Individual Case Safety Reports
Form Manager           The Form Manager actor provides the store of forms ready for use by a
Form Filler.           The Form Filler actor retrieves forms from a Form Manager as and when
                       required. When requesting a form, the Form Filler actor can optionally
                       provide context information by providing pre-population xml data in the
                       request for use by the Form Manager. The Form Filler may also specify a
                       Form Archiver actor. The Form Archiver actor specified by the Form
                       Filler is in addition to any Form Archiver actors specified by the Form
                       Manager.
Form Receiver          The Form Receiver actor receives and processes completed or partially
                       completed forms instance data from a Form Filler. Form Receiver
                       processing is out of the scope of the profile.
Form Archiver          The Form Archiver actor receives completed or partially completed forms
                       instance data and stores these for archival purposes.
Retrieve Form          The Retrieve Form transaction carries the form identifier from a Form
                       Filler to a Form Manager. The transaction also allows a Form Filler to
                       optionally specify a Form Archiver actor as well as optionally containing
                       context information in the form of xml data to be used in the selection and
                       pre-population of the requested form prior to the form being returned to
                       the Form Filler.
ICH                    International Conference on Harmonisation of Technical Requirements
                       for Registration of Pharmaceuticals for Human Use is a joint initiative
                       involving both regulators and research-based industry focusing on the
                       technical requirements for medicinal products containing new drugs.
RFD                    Retrieve Form for Data Capture Profile (RFD)
Standard CRF           Refers to a Standard Case Report Form in a ODM format which is
                       mapped to CDASH

Also refer to Glossary of ICH Terms at http://www.ich.org/cache/html/2791-272-1.html

Volume I
Drug Safety Content Profile (DSC)
Dependencies
                                    Dependency
  Content Profile     Dependency                                       Purpose
                                        Type
Drug Safety Content                  Integration     This is a content profile that will be used in
                         RFD
   Profile (DSC)                       Profile       the context of the RFD Integration profile.



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Profile Name
Drug Safety Content Profile (DSC)

DSC describes the content and format to be used within the Prepopulation Data transaction
described within the RFD Integration Profile. The purpose of this profile is to support a standard
set of data in CCD format which the Form Filler provides for use in reporting adverse events as it
relates to Drug Safety. In addition this profile will reference the ability to convert this output into
the ICH E2B(R3) standard.

Use Cases
   Drug trial
   Phase IV Studies
   Post-market surveillance
   Medication Errors

Use Case – Pharmaceutical Trial
Current State



Desired State



Use Case – Phase IV Studies


Current State



Desired State



Use Case – Post Market Surveillance
A community-based physician, Dr. Cramp, sees a patient in an outpatient clinic and accesses
the patient‟s electronic health record which reveals that the patient is on one of the new statin

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drugs. The physical examination turns up muscle weakness in the patient‟s calves, which the
physician recognizes as a possible adverse reaction to the statin. He orders a total creatinine
kinase lab test to help in diagnosing the problem.

Current State
Dr. Cramp exits the EHR and, using a web browser, goes to http://www.fda.gov/medwatch/. He
brings up form FDA 3500, for „voluntary reporting of adverse events noted spontaneously in the
course of clinical care‟. He navigates through several screens of routing and instructions to
arrive at the first screen of the actual form, which requests patient identifier, age at time of event
or date of birth, sex, and weight; the second screen requests seven entries: a classification of
the event, classification of outcome, event date, report date, description, relevant tests (he notes
that a test has been ordered), and other relevant history (the last three fields are text entry); the
third and fourth screens ask for details about the product; and so forth. In actuality, the current
state is that this form is seldom completed.

Desired State
Dr. Cramp sees the patient and accesses the EHR as above. Upon finding the potential
problem, he clicks on an „Adverse Event Reporting‟ button which uses RFD to bring up FDA
form 3500, which has been styled to the look and feel of the EHR user interface. [In the
Pfizer/Partners ASTER project, the LMR event 'Discontinue Drug for Adverse Event' triggers the
form retrieval.] The form is presented with the demographics, product name, and other data
elements already completed. Dr. Cramp completes the empty fields of the form and submits
directly to the FDA Medwatch site.

When the RFD Form Filler retrieves the XForms from the Forms Manager it automatically
provides the data elements specified in the Drug Safety Content Profile which the EHR has
retrieved from its database. The forms manager populates the form and returns it to the form
filler for display. The physician reviews the partially completed form, and fills in those sections
which the content profile did not specify. RFD Form Filler then returns the data to the Forms
Receiver.

ASTER Example
Michael Ibara (Pfizer) Review: Aster – Project at Partners Data – real world experience
Metadata – spontaneous safety falls between different initiatives ADE Spontaneous Triggered
Event Reporting (ASTER) All post-market reporting DIA Conference 2 years ago – RFD to test
model ASTER to implement automated ADE collection in ambulatory clinic setting using the
longitudinal medical record in ambulatory clinics at Partners CRIX – not for profit organization –
will help host form and process information
Data from LMR – ICSR2 format and ICH (International Council of Harmonization) E2B Standard
format as well
Spontaneous reports are not submitted due to convenience and effort and understanding When
reporting, the Pharmaceutical company becomes the “middle man” as FDA is not generally set
up to receive. ASTER plans to send the report directly from the LMR to FDA.
a. Physicians don‟t see events as adverse events
b. Physicians who recognize the events are not at a location to report
c. Data information is sparse

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Sponsor – Dr. David Bates, Dr. Jeffery Linder; Norman Marks (MedWatch at FDA) strong
supporter
Live pilot 4th quarter – September, hopefully
Plan to change timing for reporting from several days (regulatory requirement for manufacturers
of 15 day report) to minutes.

Workflow:
a. Physician in ambulatory clinic
b. atient seen with severe nausea due to antibiotic and antibiotic discontinued
c. Discontinuation includes a reason captured as an adverse event (currently within the
     Brigham LMR)
d. Trigger of reason triggers standard RFD transaction sends notice to CRIX – LMR fields are
     mapped to E2B so that the physician sees returned a partially filled form similar to a
     MedWatch form
e.   CRIX populates the form from the LMR and passes it back to the physician
f.   The physician must interact with the form - Must for “outcome” section, rest can be added
g.   Maximum of 120 sec, average 60 seconds
h.   Submit – information arrives at CRIX
i.   CRIX codes and matches to “outcome” and DME – designated medical events
j.   Attempt to triage serious events
k.   Mapping in ICH E2B format, and ICSR2 format and send to respective gateways.

MedWatch form - approximately 15 fields to map to E2B. The rest (lab, etc) is identifiable more
easily. More complex are items such as definition of "adverse events."
Requires subject matter expertise on the safety side. Also expertise in the structure and the
data model of the EHR.
Should be flexible to incorporate other elements as they are required. The effort is being
centralized from current efforts among manufacturers, removing the need for identical efforts in
each manufacturer. The effort also offloads the work from the FDA.
Significant relationships and agreements are required as well as Safety Knowledge expertise.
Such expertise is not necessarily present in existing HIEs. The design requires safety expertise
for the set up and initiation. It creates a flexible model for reuse. The minimal difference
between serious and non-serious is:

a. outcome - needing hospitalization or not
b. coding of the event

With these two items, can determine seriousness In the ambulatory setting outcome is
determined before the patient is in the clinic. In hospital adverse events may be identified during
the event and the outcome will not be available when first identified. Outcome as a regulatory
trigger is generally known in the ambulatory setting. Some follow up may still be required for
clinical outcomes.

A bi-directional communication could allow a business rule to allow a request for a 3-day or 5-
day update. This process is somewhat aligned with a case management model.
Reporting of Success: Currently have the pre-intervention number and distribution of adverse
event identification as part of the routine medication discontinuation process. The pilot will begin
with the more robust reporting physicians to be able to monitor post-intervention success.


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Does this improve the quality report - requires agreement as to what represents a "quality
report"
What new issues will be created - there are 3 categories of information:
That information requested by safety (the ICH fields)

That information requested that cannot be found in the EHR (e.g., outcome)
Information contained in the EHR that can add value to a safety report yet has not previously
been considered. - Will represent an additional requirement (potentially) for future reports.
Privacy and security - the LMR is encrypting the identifier - local pseudonymization.
Question about supplemental information - Decision support capabilities might request sending
a medical summary to add further information for analysis. (Discussion from PCC with respect
to immunization May 21).

A Drug Safety Profile will require a trigger. QED uses templates. To use a medication template,
re-use the appropriate structure and package. The profile also requires that data enters into the
form is expected within the EHR. In the Clinical Research Profile, the data elements may not be
desired within the EHR. In the Drug the data elements generally are the same as those within
the EHR. The report itself, however, would not be saved within the EHR for risk management
reasons.
The trigger events specifically are based on local implementations (e.g., an order
discontinuation, an entry to a problem list, a new entry to an allergy / adverse event list). A
trigger is the initiation point for the Drug Safety Profile.
The data source for the form filler requires discussion.
Total number of data elements that required analysis = 15, most were one-to-one maps.
Retrieved from "http://wiki.ihe.net/index.php?title=May_22"

Use Case – Medication Errors


Current State



Desired State

New Items to Include:
Workflow for Form

Queries on Multiple Patients – Supplement to ITI – Ana Estelrich

Support for Pseudonymization
New Profile ITI – Floyd Eisenberg / Lori Fourquet / Ana Estelrich


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Section on Security for Clinical Research Data Capture –
How signatures can be applies in conformance with Safe Biopharma requirements.

Actors/Transaction
This content profile addresses the Retrieve Form [IT I-34] transaction with the Pre-population
argument between the two actors, Form Filler and Form Manager. The Form Filler can request
that the Form Filler context information be used by the Form Manager in the selection and/or
creation of the returned form. The sharing of content from one actor to the other is addressed by
the appropriate use of IHE profiles described below, and is out of scope of this profile. The
Retrieve Form for Data Capture embodies the Form Filler Actor and Form Manager Actor. The
sharing of content or updates from one actor to the other is addressed by the use of appropriate
IHE profiles described by the 2007-2008 Trial Implementation Supplements to ITI-TF v. 4.0
specifically the Retrieve Form for Data Capture (RFD) supplement.




Clinical Research Data Capture Actor Diagram

Grouping

Data Classes
Data Categories

Existing Standards:
ICH:    ICH (International Conference on Harmonisation of Technical Requirements for
       Registration of Pharmaceuticals for Human Use) has published a Step 2 document and
       plans to amend E2BM (Data Elements For Transmission Of Individual Case Safety
       Reports). The exchange format will be HL7 ICSR (Individual Case Safety Report).
E2BR3: The E2BR3 guideline is currently under revision to reconsider data elements not
       previously considered, specifically drug/device combinations. There is some
       preliminary mapping to the guideline completed in the HL7 Patient Safety Workgroup.

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         A draft ballot is expected August 1, 2008 for ballot resolution during the September
         HL7 Working Meeting in Vancouver. The plan is to include the ICH conformance profile
         as an annex to the ballot to reference E2BR3. The content will then be taken to the
         ISO October meeting for reconciliation and testing can begin after that ballot.

Data requested by FDA/regulators


Data requested for outcomes - definitions, mappings


Data not requested but valuable - e.g., lab studies, relevant deltas


E2BM Mapping expertise - Michael Ibara


E2BR3 Guideline update information - HL7 Ballot - Lise Stevens


Content Bindings with RFD
The Retrieve Form for Data Capture Profile (RFD) provides a method for gathering data within a
user‟s current application to meet the requirements of an external system. RFD supports the
retrieval of forms by a Form Filler from a Form Manager optionally using prepopulation data sent
from the Form Filler and then further describes display and completion of a form, and return of
instance data from the Form Filler to the Form Reciever as well as optionally to a Form Archiver.
This content profile will be bound to the prepopulation data transaction described in RFD.

For more details on these profiles, see the IHE IT Infrastructure Technical Framework.

Content profiles may impose additional requirements on the transactions used when grouped
with actors from other IHE Profiles.

Options
                             Clinical Research Data Capture Options
                                   Actor              Option
                                 Form Filler     CCD Option (1)
                              Form Manager       CCD Option (1)

Note 1: The Actor shall support at least one of these options.



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Form Filler Options
CCD Option
This option defines that the Form Filler can produce a valid CCD as content for the
prepopulation data transaction as defined in RFD. This valid CCD will be further constrained in
volume 2 of this profile.

Form Manager Options

CCD Option
This option defines that the Form Manager can recieve a valid CCD as content for the
prepopulation data transaction as defined in RFD. This valid CCD will be further constrained in
volume 2 of this profile. Note the reference implementation that then supports conversion of this
CCD into ODM/CDASH.

Process Flow




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Clinical Research Data Capture Process Flow for CCD Option

In this CCD option, the Form Filler knows which form it wants to retrieve from the Form
Manager. In addition the Form Filler wants to send the prepopulation data for this form. The
CRD Profile in addition to this CCD option requires that this prepopulation data conform to the
Clinical Research CCD. This CCD option requires the Form Manager to accept the Clinical
Research CCD format. Inside the Form Manager there is a reference implementation (see
section below) that then describes how the Form Manager could transform this Clinical
Research CCD into Standard CRF. The data that was sent to the Form Manager is then bound
to the form and returned to the Form Filler.


Actor Definitions
Form Manager       The Form Manager actor provides the store of forms ready for use by a
Form Filler.       The Form Filler actor retrieves forms from a Form Manager as and when
                   required. When requesting a form, the Form Filler actor can optionally

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                       provide context information by providing pre-population xml data in the
                       request for use by the Form Manager. The Form Filler may also specify a
                       Form Archiver actor. The Form Archiver actor specified by the Form Filler is
                       in addition to any Form Archiver actors specified by the Form Manager.

Transaction Definitions
Retrieve Form          The Retrieve Form transaction carries the form identifier from a Form Filler
                       to a Form Manager. The transaction also allows a Form Filler to optionally
                       specify a Form Archiver actor as well as optionally containing context
                       information in the form of xml data to be used in the selection and pre-
                       population of the requested form prior to the form being returned to the Form
                       Filler.

Triggers
Management of triggers for generating drug safety content
Triggers are generally managed within the EHR workflow to request from a clinician a
determination as to whether or not an adverse event has occurred. Some triggers that have
been used include:
 In the EHR used in the ASTER project, a question each time a medication is discontinued
    for the ordering physician to enter if the discontinuation is due to an adverse event
 Automated triggers based on specific medication orders or laboratory results or clinical
    events as listed in Minutes_Drugs_Safety_Content_Profile_June_5,_2008
 Regardless, triggers require clinician determination before a drug safety content report can
    be initiated and, therefore, triggers are the responsibility / expectation of the originating
    EHR.

Sources for triggers:
         Institute for Healthcare Improvement [(IHI) http://www.ihi.org/ihi/workspace/tools/trigger/
          ADE Trigger Tools]
         Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical
          methodology for measuring medication related harm, Qual Saf Health Care.
          2003;12:194-200. - Lists 24 clinical triggers to identify potential adverse drug events. ***
          See Table Below for 24 Triggers
         Resar RK, Rozich JK, Classen D. Methodology and rationale for the measurement of
          harm with trigger tools, Qual Saf Health Care. 2003;12:ii30-ii45.
         Takata GS, Mason W, Taketomo C, Logsdon T and Sharek PJ. Development, Testing,
          and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in
          US Children's Hospitals. Pediatrics 2008;121:927-935. Full Text of Article
                              Rozich, Haraden, Resar - Clinical Triggers1

1
    Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical methodology for
    measuring medication related harm, Qual Saf Health Care. 2003;12:194-200. - Lists 24 clinical triggers
    to identify potential adverse drug events.

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                             Rozich, Haraden, Resar - Clinical Triggers1
Trigger #          Trigger                      Concern              EHR Trigger Type (added)
                                     Hypersensitivity reaction or
T1          Diphenhydramine                                         Order
                                     drug effect
                                     Over-anticoagulation with
T2          Vitamin K                                               Order
                                     warfarin
                                     Oversedation with
T3          Flumazenil                                              Order
                                     benzodiazepine
                                     Nausea/emesis related to
T4          Droperidol                                              Order
                                     drug use
T5          Naloxone                 Oversedation with narcotic     Order
T6          Antidiarrheals           Adverse drug event             Order
                                     Hyperkalemia related to renal
T7          Sodium polystyrene                                     Order
                                     impairment or drug effect
                                     Over-anticoagulation with
T8          PTT >100 seconds                                        Result occurrence
                                     heparin
                                     Over-anticoagulation with
T9          INR >6                                                  Result occurrence
                                     warfarin
                                     Neutropenia related to drug
T10         WBC <3000 × 106/μl                                      Result occurrence
                                     or disease
            Serum glucose <50        Hypoglycemia related to
T11                                                                 Result occurrence
            mg/dl                    insulin use
            Rising serum             Renal insufficiency related to Result occurence (calculated
T12
            creatinine               drug use                       delta)
            Clostridium difficile                                   Result occurrence (perhaps
T13                                  Exposure to antibiotics
            positive stool                                          order for stool C difficile)
            Digoxin level >2
T14                                  Toxic digoxin level            Result occurrence
            ng/ml
            Lidocaine level >5
T15                                  Toxic lidocaine level          Result occurrence
            ng/ml
            Gentamicin or
            tobramycin levels
T16         peak >10                 Toxic levels of antibiotics    Result occurrence
            μg/ml,trough >2
            μg/ml
            Amikacin levels peak
T17         >30 μg/ml, trough    Toxic levels of antibiotics        Result occurrence
            >10 μg/ml
            Vancomycin level
T18                                  Toxic levels of antibiotics    Result occurrence
            >26 μg/ml
T19         Theophylline level       Toxic levels of drug           Result occurrence


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                          Rozich, Haraden, Resar - Clinical Triggers1
           >20 μg/ml
           Oversedation,            Related to overuse of        Occurrence of
T20
           lethargy, falls          medication                   finding/observation
                                    Drug related/adverse drug    Occurrence of
T21        Rash
                                    event                        finding/observation
           Abrupt medication
T22                                 Adverse drug event           Order to discontinue
           stop
           Transfer to higher
T23                                 Adverse event                Order
           level of care
                                                                 Local determinant Acronyms:
           Customized to                                         PTT=prothrombin time;
T24                                 Adverse event
           individual institution                                INR=international normalized
                                                                 ratio; WBC=white blood cells
Retrieved from
"http://wiki.ihe.net/index.php?title=Minutes_Drugs_Safety_Content_Profile_June_5%2C_2008"



Volume II
Clinical Research Data Capture Content
Standards
CDAR2       Clinical Document Architecture, Release 2, 2005 HL7
CRS         Implementation Guide for CDA Release 2 – Level 1 and 2 – Care Record
Summary (US realm), 2006, HL7.
CCD         ASTM/HL7 Continuity of Care Document (Draft)

Data Element Index
CDASH has defined domains and elements within these domains. The Clinical Research CCD
described below overlays these domains. This Data Element Index is an attempt to describe
which sections are intended to cover which domains.
                       Clinical Research Data Capture Data Elements
CDASH Domains             CCD Reference
Demography                CCD Header Information
                          Active Problems, Past Medical History, and Procedures and
Medical History
                          Interventions
Concommitant
                          Current Medications
Medication
Substance Use             Social History

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Vital Signs              Vital Signs
Physical Exam            Physical Exam
Adverse Events           Allergies
Lab Test Results         Coded Results
ECG Test Results         Coded Results


Document Specification CDASH Option
           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
Common                                            Unique Identifier for a study within a
                   STUDYID               R
Identifiers                                       submission.
                   SITEID                R        Unique identifier for the site.
                   SUBJID                R        Subject identifier.
                   INVID                 O        Investigator identifier.
                   VISIT                 O        Visit Name.
Demography         BRTHYR                R        Year of subject’s birth.
                   BRTHMO                R        Month of subject’s birth.
                   BRTHDY                R2       Day of subject’s birth.
                   BRTHTM                O        Time of subject’s birth,
                                                  The assemblage of physical properties or
                                                  qualities by which male is distinguished
                                                  from female; the physical difference
                   SEX                   R
                                                  between male and female; the
                                                  distinguishing peculiarity of male or
                                                  female. (NCI – CDISC Definition).
                   AGE                   O        Numeric Age of Subject.
                   AGEU                  O        Age units.
                   DMDTC                 R2       Date of collection.
                   DMTM (Note: If
                   collected, will be
                                         O        Time of collection.
                   derived into
                   DMDTC.)
                                                  A social group characterized by a
                                                  distinctive social and cultural tradition
                                                  maintained from generation to generation,
                   ETHNIC                O
                                                  a common history and origin and a sense
                                                  of identification with the group; members
                                                  of the group have distinctive features in


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                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  their way of life, shared experiences and
                                                  often a common genetic heritage; these
                                                  features may be reflected in their
                                                  experience of health and disease.
                                                  An arbitrary classification based on
                                                  physical characteristics; a group of
                  RACE                 R
                                                  persons related by common descent or
                                                  heredity.
Subject
                  SCDTC                R2         Date of collection.
Characteristics
                  SCTM (Note: If
                  collected, will be
                                       O          Time of collection.
                  derived into
                  SCDTC.)
                                                  The age (in weeks) of the newborn infant,
                                                  counted from the first day of the woman’s
                                       O
                                                  last menstrual period (LMP) or health
                                                  status indicators / Clinical Estimate (CE).
                  SCTESTCD             O          Natural eye color
                  SCTESTCD             O          Subject’s childbearing potential
                                                  Education level achieved at start of study
                  SCTESTCD             O
                                                  (Reference date)
                  SCTESTCD             O          Sub-study participation information.
                                                  Verbatim or preprinted CRF term for the
Medical History   MHTERM               R
                                                  medical condition or event.
                                                  Identifies the end of the event as being
                  MHONG                R
                                                  ONGOING or RESOLVED.
                                                  Lead prompt for the Medical History

                  MHYN                 O          (e.g., “Has the subject experienced any
                                                  past and / or concomitant diseases or past
                                                  surgeries?”).
                                                  O sponsor-defined reference number (e.g.,
                  MHSPID               O
                                                  Preprinted line number).
                                                  Used to define a category of related
                  MHCAT                O
                                                  records (e.g., CARDIAC or GENERAL).
                                                  A categorization of the condition or event
                  MHSCAT               O
                                                  pre-printed on the CRF or instructions.


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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  A pre-printed prompt used to indicate
                  MHOCCUR              O          whether or not a medical condition has
                                                  occurred.
                  MHSTDTC              O          Start Date of Medical History Event.
                  MHENDTC              O          End Date/Time of Medical History Event.
Concommitant                                      General prompt question to aid in
                  CMYN                 O
Medication                                        monitoring and data cleaning.
                  CMSPID               O          A sponsor-defined reference number.
                                                  Verbatim drug name that is either pre-
                  CMTRT                R
                                                  printed or collected on a CRF.
                  CMINGRD              O          Medication Ingredients.
                                                  The reason for administration of a
                                                  concomitant (non-study) medication.
                                                  (e.g., Nausea, Hypertension) This is not
                  CMINDC               R2         the pharmacological/ therapeutic
                                                  classification of an agent (e.g., antibiotic,
                                                  analgesic, etc.), but the reason for its
                                                  administration to the subject.
                                                  Identifier for the adverse event that is the
                  AESPID               O
                                                  indication for this medication.
                  CMDOSTOT             R2         Total daily dose taken.
                                                  Name of the pharmaceutical dosage form
                  CMDOSFRM             O          (e.g., tablets, capsules, syrup) of delivery
                                                  for the drug.
                                                  How often the medication was taken (e.g.,
                  CMDOSFRQ             O
                                                  BID, every other week, PRN).
                  CMDSTXT (Note: If
                  collected, will be
                                                  The dose of medication taken per
                  derived into       O
                                                  administration.
                  CMDOSTXT or
                  CMDOSE.)
                                                  Within structured dosage information, the
                  CMDOSU               O          unit associated with the dose (e.g., "mg"
                                                  in "2mg three times per day).
                                                  Within structured dosage information, the
                                                  number of units for the interval (e.g., in
                  CMDOSRGM             O
                                                  oncology where drug is given 1 week on,
                                                  and 3 weeks off).


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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  Identifies the route of administration of
                  CMROUTE              R2
                                                  the drug.
                  CMSTDTC              R          Date when the medication was first taken.
                                                  Relative time frame that the medication
                  CMSTRF                          was first taken with respect to the
                                                  sponsor-defined reference period.
                  CMSTTM (Note: If
                  collected, will be
                                     R2           Time the medication was started.
                  derived into
                  CMSTDTC.)
                                                  Date that the subject stopped taking the
                  CMENDTC              R
                                                  medication.
                  CMENRF
                  CMONGO (Note: If
                                                  Indicates medication is ongoing when no
                  collected, will be O
                                                  End/Stop Date is provided.
                  derived into
                  CMENRF.)
                  CMENTM (Note: If
                  collected, will be              Time when the subject stopped taking the
                                     R2
                  derived into                    medication.
                  CMENDTC.)
                                                  The type of substance (e.g., TOBACCO,
                                                  ALCOHOL, CAFFEINE, etc. Or
Substance Use     SUTRT                R
                                                  CIGARETTES, CIGARS, COFFEE,
                                                  etc.).
                  SUNCF                R          Substance Use Occurrence.
                                                  Used to define a category of related
                  SUCAT                O          records (e.g., TOBACCO, ALCOHOL,
                                                  CAFFEINE, etc.).
                                                  Substance use consumption amounts or a
                                                  range of consumption information
                  SUDOSTXT             O
                                                  collected in text form [e.g., 1-2 (packs), 8
                                                  (ounces), etc.].
                                                  Units for SUDOSTXT (e.g., PACKS,
                  SUDOSU               O
                                                  OUNCES, etc.).
                                                  Usually expressed as the number of uses
                                                  consumed per a specific interval (e.g.,
                  SUDOSFRQ             O
                                                  PER DAY, PER WEEK,
                                                  OCCASIONAL).

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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                  SUSTDTC              O          Date substance use started.
                  SUSTTM (Note: If
                  collected, will be
                                       O          Time substance use started.
                  derived into
                  SUSTDTC.)
                  SUENDTC              O          Date substance use ended.
                  SUENTM (Note: If
                  collected, will be
                                       O          Time substance use ended.
                  derived into
                  SUENDTC.)
                  SUDUR                O          The duration of the substance use.
Vital Signs       VSDTC                R2         Date of measurements
                  VSSPID               O          Sponsor defined reference number
                                                  Study day of measurements, measured as
                  VISITDY              O
                                                  integer days
                                                  Text description of time when
                  VSTPT                O
                                                  measurement should be taken
                  VSTM (Note: If
                  collected, will be
                                       O          Time of measurements.
                  derived into
                  VSDTC.)
                                                  Verbatim name of the test or examination
                  VSTEST               R          used to obtain the measurement or
                                                  finding.
                                                  Used to indicate that a vital signs
                  VSSTAT               R2
                                                  measurement was not done.
                                                  Result of the vital signs measurement as
                  VSORRES              R
                                                  originally received or collected.
                                                  Original units in which the data were
                  VSORRESU             R
                                                  collected.
                                                  Location on body where measurement
                  VSLOC                R2
                                                  was performed.
                                                  Position of the subject during a
                  VSPOS                R
                                                  measurement or examination.
Physical Exam -
                                                  Used to indicate if exam was not done as
Best Practice     PESTAT               O
                                                  scheduled.
Approach
                  PEDTC                O          Date of examination.

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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                  PETM (Note: If
                  collected, will be
                                       O          Time of examination.
                  derived into
                  PEDTC.)
Physical Exam -
                                                  Used to indicate if exam was not done as
Traditional       PEDONE               O
                                                  scheduled.
Approach
                  PEDTC                R2         Date of examination.
                  PETM (Note: If
                  collected, will be
                                       O          Time of examination.
                  derived into
                  PEDTC.)
                  PESPID               O          Sponsor defined reference number.
                                                  General prompt question to aid in
Adverse Events    AEYN                 O
                                                  monitoring and data cleaning.
                  AESPID               O          A sponsor-defined reference number.
                                                  Verbatim (i.e., investigator reported term)
                  AETERM               R
                                                  description of the adverse event.
                                                  Indicates whether or not the adverse event
                  AESER                R          is determined to be “serious” according to
                                                  the protocol.
                  AESERTP Or
                  AESCAN
                  AESCONG
                  AESDISAB                        Captures the criteria required by protocol
                  AESDTH               O          for determining why an event is
                  AESHOSP                         “Serious”.
                  AESLIFE AESOD
                  AESMIE (see
                  below)
                                                  Captures the criteria required by protocol
                  AESCAN               O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESCONG              O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESDISAB             O          for determining why an event is
                                                  “Serious”.

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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  Captures the criteria required by protocol
                  AESDTH               O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESHOSP              O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESLIFE              O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESOD                O          for determining why an event is
                                                  “Serious”.
                                                  Captures the criteria required by protocol
                  AESMIE               O          for determining why an event is
                                                  “Serious”.
                  AESTDTC              R          Date when the adverse event started.
                  AESTTM (Note: If
                  collected, will be
                                       R2         Time when the adverse event started.
                  derived into
                  AESTDTC.)
                  AEENDTC              R          Date when the adverse event resolved.
                                                  Indicates AE is ongoing when no
                  AEENRF AEONGO O
                                                  End/Stop date is provided.
                  AEENTM (Note: If
                  collected, will be
                                     R2           Time when the adverse event resolved.
                  derived into
                  AEENDTC.)
                  AESEV And/or                    Description of the severity of the adverse
                                     R
                  AETOXGR                         event.
                                                  Indication of whether the investigational
                                                  product had a causal effect on the adverse
                  AEREL                R
                                                  event, as reported by the
                                                  clinician/investigator.
                                                  Captures a category for an investigational
                  AERELTP              R2         product to which an adverse event is
                                                  related.
                                                  Action(s) taken with the investigational
                  AEACN                R
                                                  product in response to the adverse event.


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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  Describes Other Action(s) taken in
                    AEACNOTH             O        response to the adverse event. (Does not
                                                  include investigational products)
                                                  Description of the subject’s status
                    AEOUT                R
                                                  associated with an event.
Lab Test Results -
Scenario 1: Central LBDTC                R        Date of sample collection.
processing
                    LBTM (Note: If
                    collected, will be
                                         R2       Time of collection.
                    derived into
                    LBDTC.)
                    LBSTAT               R        Status of whether or not lab was done.
                                                  Type of draw / category / panel name.
                    LBCAT LBSCAT         R2       Used to define a category of related
                                                  records.
                                                  Relative time for use when multiple
                    LBTPT                R2
                                                  sequential assessments are done.
                    LBFAST (for                   Conditions for sampling defined in the
                                         R2
                    example)                      protocol.
                    LBREFID              R2       Internal or external specimen identifier.
Lab Test Results -
Scenario 2: Local LBDTC                  R        Date of sample collection.
processing
                   LBTM (Note: If
                   collected, will be
                                         R2       Time of collection.
                   derived into
                   LBDTC.)
                   LBSTAT                R        Status of whether or not lab was done.
                                                  Type of draw / category / panel name.
                    LBCAT LBSCAT         R2       Used to define a category of related
                                                  records.
                                                  Relative time for use when multiple
                    LBTPT                R2
                                                  sequential assessments are done.
                    LBFAST (for                   Conditions for sampling defined in the
                                         R2
                    example)                      protocol.
                                                  Free or standardized text describing the
                    LBSPCCND             R2
                                                  condition of the specimen.


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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                                                  Verbatim name of the test or examination
                                                  used to obtain the measurement or
                    LBTESTCD And/or
                                    R             finding. Note any test normally performed
                    LBTEST
                                                  by a clinical laboratory is considered a lab
                                                  test.
                                                  Result of the measurement or finding as
                    LBORRES              R
                                                  originally received or collected.
                                                  Original units in which the data were
                    LBORRESU             R
                                                  collected.
                                                  Normal range for continuous
                    LBORNRLO                      measurements in original units.
                    LBORNRHI             R2
                    LBSTNRC                       Normal values for non-continuous
                                                  measurements in original units.
                                                  Reference Range Indicator Indicates
                    LBNRIND              R2       where value falls with respect to reference
                                                  range defined by high and low ranges.
                    LBCLSG (Note: If
                    collected will be
                                                  Whether lab test results were clinically
                    mapped to            R2
                                                  significant.
                    SUPPQUAL
                    domain.)
                    LBNAM                R2       Name of lab analyzing sample.
                    LBREFID              R2       Internal or external specimen identifier.
Lab Test Results -
Scenario 3: Central
processing but      LBDTC                R        Date of sample collection.
CRF includes site
assessment…
                    LBTM (Note: If
                    collected, will be
                                         R2       Time of collection.
                    derived into
                    LBDTC.)
                    LBSTAT               R        Status of whether or not lab was done.
                                                  Type of draw / category / panel name.
                    LBCAT LBSCAT         R2       Used to define a category of related
                                                  records.
                                                  Relative time for use when multiple
                    LBTPT                R2
                                                  sequential assessments are done,

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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                    LBFAST (for                   Conditions for sampling defined in the
                                         R2
                    example)                      protocol.
                                                  Verbatim name of the test or examination
                                                  used to obtain the measurement or
                    LBTEST               R        finding. Note: any test normally
                                                  performed by a clinical laboratory is
                                                  considered a lab test.
                                                  Result of the measurement or finding as
                    LBORRES              R2
                                                  originally received or collected.
                    LBCLSG (Note: If
                    collected will be
                                                  Whether lab test results were clinically
                    mapped to            R
                                                  significant.
                    SUPPQUAL
                    domain.)
                    LBNAM                R2       Name of lab analyzing sample.
                    LBREFID              R2       Internal or external specimen identifier.
ECG Test Results -
Scenario 1: Central LBDTC                R        Date of sample collection.
reading…
                    LBTM (Note: If
                    collected, will be
                                         O        Time of collection.
                    derived into
                    LBDTC.)
                    SBSTAT               R        Status of whether or not lab was done.
                                                  Type of draw / category / panel name.
                    LBCAT LBSCAT         R2       Used to define a category of related
                                                  records.
                                                  Relative time for use when multiple
                    LBTPT                R2
                                                  sequential assessments are done.
                    LBFAST (for                   Conditions for sampling defined in the
                                         O
                    example)                      protocol.
                    LBREFID              O        Internal or external specimen identifier.
ECG Test Results -
Scenario 2: Local EGSTAT                 R        Status of whether or not ECG was done.
reading: ECGs…
                                                  Describes why the ECG was not done
                    EGREASND             O        (e.g., BROKEN EQUIPMENT,
                                                  SUBJECT REFUSED).


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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                  EGDTC                R          Date of ECG.
                  EGTM (Note: If
                  collected, will be
                                       R2         Time of ECG.
                  derived into
                  EGDTC.)
                                                  Text description of planned time point
                                                  when measurements should be taken for
                  EGTPT                R2
                                                  use when multiple sequential assessments
                                                  are done
                                                  Verbatim name of the test or examination
                  EGTESTCD And/or
                                  R               used to obtain the measurement or
                  EGTEST
                                                  finding.
                                                  Result of the measurement or finding as
                  EGORRES              R
                                                  originally received or collected.
                                                  Original units in which the data were
                  EGORRESU             R2
                                                  collected.
                  EGCLSG (Note: If
                  collected will be
                                                  Whether ECG results were clinically
                  mapped to            O
                                                  significant.
                  SUPPQUAL
                  domain.)
                  EGPOS,
                                                  Condition for testing defined in the
                  EGMETHOD (for        O
                                                  protocol.
                  example)
                                                  Role of the person who provided the
                                                  evaluation. This should only be used for
                                                  results that are subjective (e.g., assigned
                  EGEVAL               O          by a person or a group) and do not apply
                                                  to quantitative results (i.e.
                                                  ADJUDICATION COMMITTEE,
                                                  INVESTIGATOR).
                  EGREFID              O          Internal or external identifier.
ECG Test Results -
Scenario 3: Central
                    EGSTAT             R          Status of whether or not ECG was done.
reading (as in
Scenario 1): But…
                                                  Describes why the ECG was not done
                  EGREASND             O          (e.g., BROKEN EQUIPMENT,
                                                  SUBJECT REFUSED).

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           Clinical Research Data Capture Constraints (CDASH Option)
                Clinical Database
 CDASH Domain                      Optionality             Definition
                  Variable Name
                  EGDTC                 R          Date of ECG.
                  EGTM (Note: If
                  collected, will be
                                        R2         Time of ECG.
                  derived into
                  EGDTC.)
                                                   Text description of planned time point
                                                   when measurements should be taken for
                  EGTPT                 R2
                                                   use when multiple sequential assessments
                                                   are done.
                                                   Verbatim name of the test or examination
                  EGTEST                R          used to obtain the measurement or
                                                   finding.
                                                   Original units in which the data were
                  EGORRESU              R2
                                                   collected.
                  EGCLSG (Note: If
                  collected, will be
                                                   Whether ECG results were clinically
                  mapped to             R
                                                   significant.
                  SUPPQUAL
                  domain.)
                                                   Result of the measurement or finding as
                  EGORRES               R2
                                                   originally received or collected.
                                                   Original units in which the data were
                  EGORRESU              R2
                                                   collected.
                  EGNAM                 R2         Name of vendor providing ECG data.
                  EGPOS,
                                                   Conditions for testing defined in the
                  EGMETHOD (for         O
                                                   protocol.
                  example)
                  EGREFID               O          Internal or external ECG identifier.



                                       Optionality Key

                            R Required Section
                            R2 Required Section if data present
                            O Optional section


Document Specification CCD Option

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               Clinical Research Data Capture Constraints (CCD Option)
          Data Element           Optionality                Template ID
Date of Birth                      R           patientRole/patient/birthTime
Gender                             R           patientRole/patient/administrativeGenderCode
Ethnicity                          O           patientRole/patient/ethnicGroupCode
Race                               R2          patientRole/patient/raceCode
Active Problems                    R           1.3.6.1.4.1.19376.1.5.3.1.3.6
Past Medical History               R2          1.3.6.1.4.1.19376.1.5.3.1.3.8
Procedures and Interventions       R2          1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11
Social History                     R2          1.3.6.1.4.1.19376.1.5.3.1.3.16
Current Medications                R           1.3.6.1.4.1.19376.1.5.3.1.3.19
Vital Signs                        R2          1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2
Physical Exam                      R2          1.3.6.1.4.1.19376.1.5.3.1.1.9.15
Allergies and Other Adverse
                                   R           1.3.6.1.4.1.19376.1.5.3.1.3.13
Reactions
Coded Results                      R2          1.3.6.1.4.1.19376.1.5.3.1.3.28

Header Sample

In order to ensure sufficient coverage to the Demography Domain within CDASH there are some
constraints that have been applied to the Clinical Research CCD header. Specifically the
Birthdate, Sex, Ethnicity, and Race are specified.

  <recordTarget>
    <patientRole classCode="PAT">
      <id root="27143B24-E580-4F47-9405-3D0DC2BF1223" extension="1022"/>
      <addr>
        <streetAddressLine/>
        <city/>
        <state>FM</state>
        <postalCode/>
        <country>Canada</country>
      </addr>
      <telecom nullFlavor="UNK" use="HP"/>
      <patient classCode="PSN" determinerCode="INSTANCE">
        <name>
          <prefix/>
          <given>Christine</given>
          <family>Smith</family>
          <suffix/>
        </name>
        <ethnicGroupCode code="364699009" displayName="ethnic group"
          codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT"/>
        <administrativeGenderCode code="F"
codeSystem="2.16.840.1.113883.5.1"/>
        <birthTime value="20040725"/>

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        <raceCode code=”2106-3” codeSystem=”2.16.840.1.113883.5.104”/>
      </patient>
      <providerOrganization classCode="ORG" determinerCode="INSTANCE">
        <id root="2.16.840.1.113883.19.5"/>
      </providerOrganization>
    </patientRole>
  </recordTarget>

Active Problems Sample (1.3.6.1.4.1.19376.1.5.3.1.3.6)
<component>
  <section>
    <templateId root='2.16.840.1.113883.10.20.1.11'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.6'/>
    <id root=' ' extension=' '/>
    <code code='11450-4' displayName='PROBLEM LIST'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Problem Concern Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/>
         :
    </entry>

  </section>
</component>

Past Medical History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.8)
<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.8'/>
    <id root=' ' extension=' '/>
    <code code='11348-0' displayName='HISTORY OF PAST ILLNESS'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Problem Concern Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.2'/>
         :
    </entry>

  </section>
</component>

Procedures and Interventions Sample (1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11)

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<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.13.2.11'/>
    <id root=' ' extension=' '/>
    <code code='X-PROC' displayName='PROCEDURES PERFORMED'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
      Required and optional entries as described above
    </entry>

  </section>
</component>

Social History Sample (1.3.6.1.4.1.19376.1.5.3.1.3.16)
<component>
  <section>
    <templateId root='2.16.840.1.113883.10.20.1.15'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.16'/>
    <id root=' ' extension=' '/>
    <code code='29762-2' displayName='SOCIAL HISTORY'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>

  </section>
</component>

Current Medications Sample (1.3.6.1.4.1.19376.1.5.3.1.3.19)
<component>
  <section>    <templateId root='2.16.840.1.113883.10.20.1.8'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.19'/>
    <id root=' ' extension=' '/>
    <code code='10160-0' displayName='HISTORY OF MEDICATION USE'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Medications element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.7'/>
         :
    </entry>

  </section>
</component>



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Vital Signs Sample (1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2)
<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2'/>
    <id root=' ' extension=' '/>
    <code code='8716-3' displayName='VITAL SIGNS'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Vital Signs Organizer element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.13.1'/>
         :
    </entry>

  </section>
</component>

Physical Exam Sample (1.3.6.1.4.1.19376.1.5.3.1.1.9.15)
<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.24'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.15'/>
    <id root=' ' extension=' '/>
    <code code='29545-1' displayName='PHYSICAL EXAMINATION'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.25'/>
        <!-- Optional Vital Signs Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.16'/>
        <!-- Optional General Appearance Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.48'/>
        <!-- Optional Visible Implanted Medical Devices Section content -->
      </section>
    </component>
    <component>


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      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.17'/>
        <!-- Optional Integumentary System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.18'/>
        <!-- Optional Head Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.19'/>
        <!-- Optional Eyes Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.20'/>
        <!-- Optional Ears, Nose, Mouth and Throat Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.21'/>
        <!-- Optional Ears Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.22'/>
        <!-- Optional Nose Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.23'/>
        <!-- Optional Mouth, Throat, and Teeth Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.24'/>
        <!-- Optional Neck Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.25'/>
        <!-- Optional Endocrine System Section content -->
      </section>
    </component>
    <component>
      <section>

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        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.26'/>
        <!-- Optional Thorax and Lungs Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.27'/>
        <!-- Optional Chest Wall Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.28'/>
        <!-- Optional Breasts Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.29'/>
        <!-- Optional Heart Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.30'/>
        <!-- Optional Respiratory System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.31'/>
        <!-- Optional Abdomen Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.32'/>
        <!-- Optional Lymphatic System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.34'/>
        <!-- Optional Musculoskeletal System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.35'/>
        <!-- Optional Neurologic System Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.36'/>

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        <!-- Optional Genitalia Section content -->
      </section>
    </component>
    <component>
      <section>
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.1.9.37'/>
        <!-- Optional Rectum Section content -->
      </section>
    </component>

  </section>
</component>

Allergies and Other Adverse Reactions Sample (1.3.6.1.4.1.19376.1.5.3.1.3.13)
<component>
  <section>
    <templateId root='2.16.840.1.113883.10.20.1.2'/>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.13'/>
    <id root=' ' extension=' '/>
    <code code='48765-2' displayName='Allergies, adverse reactions, alerts'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Allergies and Intolerances Concern element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.5.3'/>
         :
    </entry>

  </section>
</component>

Coded Results Sample (1.3.6.1.4.1.19376.1.5.3.1.3.28)
<component>
  <section>
    <templateId root='1.3.6.1.4.1.19376.1.5.3.1.3.28'/>
    <id root=' ' extension=' '/>
    <code code='30954-2' displayName='STUDIES SUMMARY'
      codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/>
    <text>
      Text as described above
    </text>
    <entry>
         :
      <!-- Required Procedure Entry element -->
        <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.16'/>
         :
    </entry>
    <entry>


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          :
       <!-- Required if known References Entry element -->
         <templateId root='1.3.6.1.4.1.19376.1.5.3.1.4.4'/>
          :
     </entry>

  </section>
</component>


Reference Implementation
Clinical Research CCD to Standard CRF (ODM/CDASH)
Crosswalk
This section is intended to be a guide as to how a Form Manager would crosswalk a Clinical
Research CCD structure into a CDASH compliant ODM structure (Standard CRF). The adopted
format for this transformation from one structure to the other is an XSLT. The intent is to have
this XSLT not be presented here within the CRD profile and remain static, but to further develop
and refine this XSLT as supplemental material. The goal is to allow additional Use Cases to
drive different flavors of transformations all of which might be available to be referenced. IHE is
developing processes which aren't ready at time of this publication to help maintain source
control and facilitate sharing and updating of this as well as other reference transformations.
When the IHE process and procedures are determined this section will refer to those
documents.




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XSLT Sample
<?xml version="1.0" encoding="UTF-8"?>
<!-- mapping CCD to ODM/CDASH elements -->
<xsl:stylesheet version="1.0" xmlns:xsl="http://www.w3.org/1999/XSL/Transform"      xmlns:cda="urn:hl7-
org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" exclude-result-prefixes="cda">
<xsl:output method="xml" version="1.0" encoding="UTF-8" indent="yes" omit-xml-declaration="no"/>

<xsl:template match="cda:ClinicalDocument">
        <ODM xmlns:cd="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/xmldsig#"
                xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ODMVersion="1.3" FileOID="CLL.003"
                PriorFileOID="CRF_CLL_v1.6" FileType="SnapShot" Description="IHE CDASH from CCD">
                <ClinicalData>
                        <SubjectData>
                                <SiteRef>
                                        <StudyEventData>
                                                <!--    ODM/CDASH.CommonIdentifiers    -->
                                                <xsl:call-template name="demography"/>
                                                <!--    ODM/CDASH.SubjectCharacteristics    -->
                                                <xsl:call-template name="medicalHistory"/>
                                                <xsl:call-template name="conMeds"/>
                                                <xsl:call-template name="substanceAbuse"/>
                                                <xsl:call-template name="vitalSigns"/>
                                                <!--    ODM/CDASH.Physical Exam        -->
                                                <xsl:call-template name="adverseEvents"/>
                                                <xsl:call-template name="labResults"/>
                                                <!--    ODM/CDASH.ECG results -->
                                        </StudyEventData>
                                </SiteRef>
                        </SubjectData>
                </ClinicalData>
        </ODM>
</xsl:template>


<!--    Demography     -->
<xsl:template name="demography">
        <xsl:variable name="patientNode" select="cda:recordTarget/cda:patientRole/cda:patient"/>


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        <FormData>
                <xsl:attribute name="FormOID">DemographicsForm</xsl:attribute>
                <ItemGroupData ItemGroupOID='DM'>
                        <ItemData ItemOID='SEX'>
                                <xsl:attribute name="value">
                                        <xsl:value-of
select="$patientNode/cda:administrativeGenderCode/@code"/>
                                </xsl:attribute>
                        </ItemData>
                        <ItemData ItemOID='BRTHDTC'>
                                <xsl:choose>
                                        <xsl:when test="$patientNode/cda:birthTime/@value">
                                                <xsl:attribute name="value">
                                                        <xsl:value-of
select="$patientNode/cda:birthTime/@value"/>
                                                </xsl:attribute>
                                        </xsl:when>
                                        <xsl:otherwise>
                                                <xsl:attribute name="nullFlavor">UNK</xsl:attribute>
                                        </xsl:otherwise>
                                </xsl:choose>
                        </ItemData>
                        <ItemData ItemOID='ETHNIC'>
                                <xsl:attribute name="value">
                                        <xsl:value-of select="$patientNode/cda:ethnicityCode/@displayName"/>
                                </xsl:attribute>
                        </ItemData>
                        <ItemData ItemOID='RACE'>
                                <xsl:attribute name="value">
                                        <xsl:value-of select="$patientNode/cda:raceCode/@displayName"/>
                                </xsl:attribute>
                        </ItemData>
                </ItemGroupData>
        </FormData>
</xsl:template>


<!--    Medical History - looking for entries in any of the following CDA sections:       Conditions, Past
Medical History, Procedures    -->

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<xsl:template name="medicalHistory">
        <xsl:variable name="ccdConditions"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='11450-4']"/>
        <xsl:variable name="ccdPMH"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='11348-0']"/>
        <xsl:variable name="ccdProcedures"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='47519-4']"/>
        <xsl:variable name="conditionsCount" select="count($ccdConditions/cda:entry)"/>
        <xsl:variable name="pmhCount" select="count($ccdPMH/cda:entry)"/>
        <xsl:variable name="proceduresCount" select="count($ccdProcedures/cda:entry)"/>

        <xsl:if test="($conditionsCount+$pmhCount+$proceduresCount)>0">
                <FormData FormOID='MedicalHistory'>
                        <xsl:for-each select="$ccdConditions/cda:entry">
                                <ItemGroupData ItemGroupOID='CONDITION'>
                                        <xsl:call-template name="problemItemData">
                                                <xsl:with-param name="theNode" select="."/>
                                        </xsl:call-template>
                                </ItemGroupData>
                        </xsl:for-each>
                        <xsl:for-each select="$ccdPMH/cda:entry">
                                <ItemGroupData ItemGroupOID='PASTCONDITION'>
                                        <xsl:call-template name="problemItemData">
                                                <xsl:with-param name="theNode" select="."/>
                                        </xsl:call-template>
                                </ItemGroupData>
                        </xsl:for-each>
                        <xsl:for-each select="$ccdProcedures/cda:entry">
                                <ItemGroupData ItemGroupOID='PROCEDURE'>
                                        <xsl:call-template name="procedureItemData">
                                                <xsl:with-param name="theNode" select="."/>
                                        </xsl:call-template>
                                </ItemGroupData>
                        </xsl:for-each>
                </FormData>
        </xsl:if>
</xsl:template>




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<!--    CON MEDS        -->
<xsl:template name="conMeds">
        <xsl:variable name="ccdMedication"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='10160-0']"/>
        <xsl:variable name="conMedCount" select="count($ccdMedication/cda:entry)"/>
        <xsl:if test="$conMedCount>0">
                <FormData FormDataOID='ConMedForm'>
                <xsl:for-each select="$ccdMedication/cda:entry">
                        <xsl:variable name="originalTextRef"
select="cda:substanceAdministration/cda:consumable/cda:manufacturedProduct/cda:manufacturedMaterial/cda:cod
e/cda:originalText/cda:reference/@value"/>
                        <xsl:variable name="originalText"
select="cda:substanceAdministration/cda:consumable/cda:manufacturedProduct/cda:manufacturedMaterial/cda:cod
e/cda:originalText"/>
                        <ItemGroupData ItemGroupOID='CM'>
                                <ItemData ItemDataOID='CMTRT'>
                                        <xsl:attribute name="value">
                                                <xsl:choose>
                                                        <xsl:when test="$originalTextRef"><xsl:value-of
select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
                                                        <xsl:otherwise><xsl:value-of
select="$originalText"/></xsl:otherwise>
                                                </xsl:choose>
                                        </xsl:attribute>
                                </ItemData>
                                <!--    Need table to translate HL7 frequency, e.g., 6h to BID        -->
                                <xsl:variable name="routeCode"
select="cda:substanceAdministration/cda:routeCode/@displayName"/>
                                <xsl:if test="$routeCode">
                                        <ItemData ItemDataOID='CMROUTE'>
                                                <xsl:attribute name="value"><xsl:value-of
select="$routeCode"/></xsl:attribute>
                                        </ItemData>
                                </xsl:if>
                                <xsl:variable name="medStartDate"
select="cda:substanceAdministration/cda:effectiveTime[@xsi:type='IVL_TS']/cda:low/@value"/>
                                <xsl:if test="$medStartDate">
                                        <ItemData ItemDataOID='CMSTDTC'>



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                                               <xsl:attribute name="value"><xsl:value-of
select="$medStartDate"/></xsl:attribute>
                                       </ItemData>
                               </xsl:if>
                               <xsl:variable name="medEndDate"
select="cda:substanceAdministration/cda:effectiveTime[@xsi:type='IVL_TS']/cda:high/@value"/>
                               <xsl:if test="$medEndDate">
                                       <ItemData ItemDataOID='CMENDDTC'>
                                               <xsl:attribute name="value"><xsl:value-of
select="$medEndDate"/></xsl:attribute>
                                       </ItemData>
                               </xsl:if>
                               <xsl:variable name="medIndicationValueNode"
select="cda:substanceAdministration/cda:precondition/cda:criterion/cda:value"/>
                               <xsl:if test="$medIndicationValueNode/@displayName">
                                       <ItemData ItemDataOID='CMINDC'>
                                               <xsl:attribute name="value">
                                                       <xsl:value-of
select="$medIndicationValueNode/@displayName"/>
                                               </xsl:attribute>
                                               <xsl:attribute name="xsi:type">
                                                       <xsl:value-of
select="$medIndicationValueNode/@xsi:type"/>
                                               </xsl:attribute>
                                               <xsl:attribute name="code">
                                                       <xsl:value-of select="$medIndicationValueNode/@code"/>
                                               </xsl:attribute>
                                               <xsl:attribute name="codeSystem">
                                                       <xsl:value-of
select="$medIndicationValueNode/@codeSystem"/>
                                               </xsl:attribute>
                                       </ItemData>
                               </xsl:if>
                               <xsl:variable name="medDoseQuantity"
select="cda:substanceAdministration/cda:doseQuantity/@value"/>
                               <xsl:if test="$medDoseQuantity">
                                       <ItemData ItemDataOID='CMDSTXT'>
                                               <xsl:attribute name="value">
                                                       <xsl:value-of select="$medDoseQuantity"/>

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                                                   </xsl:attribute>
                                           </ItemData>
                                   </xsl:if>
                                   </ItemGroupData>
                </xsl:for-each>
                </FormData>
        </xsl:if>
</xsl:template>


<!--    SUBSTANCE ABUSE        -->
<xsl:template name="substanceAbuse">
        <!-- we could look into the social history for any of a specific list of substance abuse
entries...if any are present then we emit the section -->
        <!-- however, there are probably too many codes to consider....just quickly looking we see several
SNOMED codes for smoking, cigarette smoking, .... -->
</xsl:template>


<!-- Vital Signs -->
<xsl:template name="vitalSigns">
        <xsl:variable name="vitalsSection"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='8716-3']"/>
        <xsl:if test="$vitalsSection/cda:entry/cda:organizer">
                <FormData FormDataOID='VSForm'>
                        <xsl:for-each select="$vitalsSection/cda:entry/cda:organizer/cda:component">
                                <xsl:variable name="vitalsDateTime"
select="cda:observation/cda:effectiveTime/@value"/>
                                <ItemGroupData ItemGroupDataOID='VS'>
                                        <ItemData ItemDataOID='VSDTC'>
                                                <xsl:attribute name="value">
                                                        <xsl:value-of select="$vitalsDateTime"/>
                                                </xsl:attribute>
                                        </ItemData>
                                        <xsl:variable name="vitalsResultNode"
select="cda:observation/cda:value"/>
                                        <ItemData ItemDataOID='VSTEST'>
                                                <xsl:attribute name="value">



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                                                        <xsl:value-of
select="cda:observation/cda:code/@displayName"/>
                                                </xsl:attribute>
                                        </ItemData>
                                        <xsl:choose>
                                                <xsl:when test="$vitalsResultNode/@xsi:type='PQ'">
                                                        <ItemData ItemDataOID='VSORRES'>
                                                                <xsl:attribute name="value"><xsl:value-of
select="$vitalsResultNode/@value"/></xsl:attribute>
                                                        </ItemData>
                                                        <ItemData ItemDataOID='VSORRESU'>
                                                                <xsl:attribute name="value"><xsl:value-of
select="$vitalsResultNode/@unit"/></xsl:attribute>
                                                        </ItemData>
                                                </xsl:when>
                                                <xsl:otherwise>
                                                        <ItemData ItemDataOID='VSORRES'><xsl:attribute
name="value"><xsl:value-of select="$vitalsResultNode"/></xsl:attribute></ItemData>
                                                </xsl:otherwise>
                                        </xsl:choose>
                                </ItemGroupData>
                        </xsl:for-each>
                </FormData>
        </xsl:if>
</xsl:template>


<!--    LB      -->
<xsl:template name="labResults">
        <xsl:variable name="LRSection"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='30954-2']"/>
        <xsl:if test="$LRSection/cda:entry/cda:organizer">
                <FormData FormDataOID='LBForm'>
                        <xsl:for-each
select="$LRSection/cda:entry/cda:organizer/cda:component/cda:observation">
                                <ItemGroupData ItemGroupDataOID='LB'>
                                        <ItemData ItemDataOID='LBDTC'>
                                                <xsl:attribute name="value">
                                                        <xsl:value-of select="cda:effectiveTime/@value"/>

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                                              </xsl:attribute>
                                      </ItemData>
                                      <ItemData ItemDataOID='LBSTAT'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:statusCode/@code"/>
                                              </xsl:attribute>
                                      </ItemData>
                                      <ItemData ItemDataOID='LBREFID'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:id/@root"/>
                                              </xsl:attribute>
                                              <xsl:attribute name="code">
                                                      <xsl:value-of select="cda:code/@code"/>
                                              </xsl:attribute>
                                              <xsl:attribute name="codeSystem">
                                                      <xsl:value-of select="cda:code/@codeSystem"/>
                                              </xsl:attribute>
                                      </ItemData>
                                      <ItemData ItemDataOID='LBTEST'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:code/@displayName"/>
                                              </xsl:attribute>
                                      </ItemData>
                                      <ItemData ItemDataOID='LBORRES'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:value/@value"/>
                                              </xsl:attribute>
                                              <xsl:attribute name="xsi:type">
                                                      <xsl:value-of select="cda:value/@xsi:type"/>
                                              </xsl:attribute>
                                      </ItemData>
                                      <ItemData ItemDataOID='LBORRESU'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:value/@unit"/>
                                              </xsl:attribute>
                                      </ItemData>
                                      <xsl:choose>
                                              <xsl:when
test="cda:referenceRange/cda:observationRange/cda:value/cda:low/@value">

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                                                      <ItemData ItemDataOID='LBORNRLO'>
                                                              <xsl:attribute name="value">
                                                                              <xsl:value-of
select="cda:referenceRange/cda:observationRange/cda:value/cda:low/@value"/>
                                                              </xsl:attribute>
                                                      </ItemData>
                                              </xsl:when>
                                              <!--<xsl:otherwise>
                                                      <ItemData ItemDataOID='LBORNRLO'>
                                                              <xsl:attribute name="text">
                                                                      <xsl:value-of
select="cda:referenceRange/cda:observationRange/cda:text"/>
                                                              </xsl:attribute>
                                                      </ItemData>
                                              </xsl:otherwise>-->
                                      </xsl:choose>
                                      <xsl:choose>
                                              <xsl:when
test="cda:referenceRange/cda:observationRange/cda:value/cda:high/@value">
                                                      <ItemData ItemDataOID='LBORNRHI'>
                                                              <xsl:attribute name="value">
                                                                              <xsl:value-of
select="cda:referenceRange/cda:observationRange/cda:value/cda:high/@value"/>
                                                              </xsl:attribute>
                                                      </ItemData>
                                              </xsl:when>
                                              <!--<xsl:otherwise>
                                                      <ItemData ItemDataOID='LBORNRHI'>
                                                              <xsl:attribute name="text">
                                                                      <xsl:value-of
select="cda:referenceRange/cda:observationRange/cda:text"/>
                                                              </xsl:attribute>
                                                      </ItemData>
                                              </xsl:otherwise>-->
                                      </xsl:choose>
                                      <ItemData ItemDataOID='LBNRIND'>
                                              <xsl:attribute name="value">
                                                      <xsl:value-of select="cda:interpretationCode/@code"/>
                                              </xsl:attribute>

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                                                    <xsl:attribute name="codeSystem">
                                                            <xsl:value-of
select="cda:interpretationCode/@codeSystem"/>
                                                </xsl:attribute>
                                        </ItemData>
                                </ItemGroupData>
                        </xsl:for-each>
                </FormData>
        </xsl:if>
</xsl:template>


<!--    AE      -->
<xsl:template name="adverseEvents">
        <xsl:variable name="aeSection"
select="cda:component/cda:structuredBody/cda:component/cda:section[cda:code/@code='48765-2']"/>
        <xsl:if test="$aeSection/cda:entry/cda:act">
                <FormData FormDataOID='AEForm'>
                        <xsl:for-each select="$aeSection/cda:entry">
                                <ItemDataGroup ItemDataGroupOID='AE'>
                                <xsl:variable name="originalTextRef"
select="cda:act/cda:entryRelationship/cda:observation/cda:participant/cda:participantRole/cda:playingEntity
/cda:code/cda:originalText/cda:reference/@value"/>
                                <xsl:variable name="codedDisplayName"
select="cda:act/cda:entryRelationship/cda:observation/cda:participant/cda:participantRole/cda:playingEntity
/cda:code/@displayName"/>
                                <ItemData ItemDataOID='AETERM'>
                                        <xsl:attribute name="value">
                                                <xsl:choose>
                                                        <xsl:when test="$originalTextRef"><xsl:value-of
select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
                                                        <xsl:otherwise><xsl:value-of
select="$codedDisplayName"/></xsl:otherwise>
                                                </xsl:choose>
                                        </xsl:attribute>
                                </ItemData>
                                <xsl:variable name="aeStartDateTime"
select="cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/@value"/>
                                <xsl:if test="$aeStartDateTime">

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                                        <ItemData ItemDataOID='AESTDTC'>
                                                <xsl:attribute name="value">
                                                        <xsl:value-of select="$aeStartDateTime"/>
                                                </xsl:attribute>
                                        </ItemData>
                                </xsl:if>
                        </ItemDataGroup>
                        </xsl:for-each>
                </FormData>
        </xsl:if>
</xsl:template>


<!-- helper templates -->
<!-- CDASH a med history item -->
<xsl:template name="problemItemData">
<xsl:param name="theNode"/>
        <!-- we may be pointed to the text of the condition, or we may just have a coded value display name
-->
        <xsl:variable name="originalTextRef"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:text/cda:reference/@value"/>
        <xsl:variable name="codedValue"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:value/@displayName"/>
        <xsl:variable name="valueNode"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:value"/>
        <!-- problem status translates into the CDASH MHONG -->
        <xsl:variable name="problemStatusNode"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:entryRelationship/cda:observation[cda:co
de/@code='33999-4']"/>
        <!-- can have status coded or by reference -->
        <xsl:variable name="problemStatusRef" select="$problemStatusNode/cda:text/cda:reference/@value"/>
        <!-- onset and end dates for problems -->
        <xsl:variable name="problemOnset"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/cda:low/@value"/>
        <xsl:variable name="problemResolved"
select="$theNode/cda:act/cda:entryRelationship/cda:observation/cda:effectiveTime/cda:high/@value"/>
        <ItemData ItemOID='MHTERM'>
                <xsl:choose>
                        <xsl:when test="string-length($codedValue)>0">

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                                <xsl:attribute name="value">
                                        <xsl:value-of select="$codedValue"/>
                                </xsl:attribute>
                                <xsl:attribute name="xsi:type">
                                        <xsl:value-of select="$valueNode/@xsi:type"/>
                                </xsl:attribute>
                                <xsl:attribute name="code">
                                        <xsl:value-of select="$valueNode/@code"/>
                                </xsl:attribute>
                                <xsl:attribute name="codeSystem">
                                        <xsl:value-of select="$valueNode/@codeSystem"/>
                                </xsl:attribute>
                        </xsl:when>
                        <xsl:when test="string-length($originalTextRef)>0">
                                <xsl:attribute name="value">
                                        <xsl:value-of select="//*[@ID=substring-
after($originalTextRef,'#')]"/>
                                </xsl:attribute>
                        </xsl:when>
                        <xsl:otherwise>
                                <xsl:attribute name="value">
                                        ???
                                </xsl:attribute>
                        </xsl:otherwise>
                </xsl:choose>
        </ItemData>
        <ItemData ItemOID='MHONG'>
                <xsl:attribute name="value">
                        <xsl:choose>
                                <xsl:when
test="$problemStatusNode/cda:value/@displayName='Active'">ONGOING</xsl:when>
                                <xsl:when test="//*[@ID=substring-
after($problemStatusRef,'#')]='Active'">ONGOING</xsl:when>
                                <xsl:otherwise>RESOLVED</xsl:otherwise>
                        </xsl:choose>
                </xsl:attribute>
        </ItemData>
        <!--<xsl:comment>research adding type and category (MHCAT, MHSCAT)</xsl:comment>-->



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        <!-- NOTE: might need a more generic template to handle the multiple ways that time can be reported
in ccd -->
        <xsl:if test="$problemOnset">
                <ItemData ItemDataOID='MHSTDTC'>
                        <xsl:attribute name="value">
                                <xsl:value-of select="$problemOnset"/>
                        </xsl:attribute>
                </ItemData>
        </xsl:if>
        <xsl:if test="$problemResolved">
                <ItemData ItemDataOID='MHENDDTC'>
                        <xsl:attribute name="value">
                                <xsl:value-of select="$problemResolved"/>
                        </xsl:attribute>
                </ItemData>
        </xsl:if>
</xsl:template>


<xsl:template name="procedureItemData">
<xsl:param name="theNode"/>
        <xsl:variable name="originalTextRef"
select="$theNode/cda:procedure/cda:code/cda:originalText/cda:reference/@value"/>
        <xsl:variable name="codedValue" select="$theNode/cda:procedure/cda:code/@displayName"/>
        <ItemData ItemOID='MHTERM'>
                <xsl:attribute name="value">
                        <xsl:choose>
                                <xsl:when test="string-length($originalTextRef)>0"><xsl:value-of
select="//*[@ID=substring-after($originalTextRef,'#')]"/></xsl:when>
                                <xsl:when test="string-length($codedValue)>0"><xsl:value-of
select="$codedValue"/></xsl:when>
                                <xsl:otherwise>???</xsl:otherwise>
                        </xsl:choose>
        </xsl:attribute>
        </ItemData>
        <!-- NOTE: is this true = procedures are RESOLVED -->
        <ItemData ItemDataOID='MHONG' value='RESOLVED'/>
        <!--<xsl:comment>??? what to do about an effectiveTime of center ???</xsl:comment>-->
</xsl:template>

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</xsl:stylesheet>


Sample Standard CRF output from the Sample XSLT
<?xml version="1.0"?>
<ODM ODMVersion="1.3" FileOID="CLL.003" PriorFileOID="CRF_CLL_v1.6" FileType="SnapShot" Description="IHE
CDASH from CCD" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
xmlns:cd="http://www.cdisc.org/ns/odm/v1.3" xmlns:ds="http://www.w3.org/2000/09/xmldsig#">
        <ClinicalData>
                <SubjectData>
                        <SiteRef>
                                <StudyEventData>
                                        <FormData FormOID="DemographicsForm">
                                                <ItemGroupData ItemGroupOID="DM">
                                                        <ItemData ItemOID="SEX" value="M"/>
                                                        <ItemData ItemOID="BRTHDTC" value="19320924"/>
                                                        <ItemData ItemOID="ETHNIC" value=""/>
                                                        <ItemData ItemOID="RACE" value=""/>
                                                </ItemGroupData>
                                        </FormData>
                                        <FormData FormOID="MedicalHistory">
                                                <ItemGroupData ItemGroupOID="CONDITION">
                                                        <ItemData ItemOID="MHTERM" value="Asthma"
xsi:type="CD" code="195967001" codeSystem="2.16.840.1.113883.6.96"/>
                                                        <ItemData ItemOID="MHONG" value="ONGOING"/>
                                                        <ItemData ItemDataOID="MHSTDTC" value="1950"/>
                                                </ItemGroupData>
                                                <ItemGroupData ItemGroupOID="CONDITION">
                                                        <ItemData ItemOID="MHTERM" value="Pneumonia"
xsi:type="CD" code="233604007" codeSystem="2.16.840.1.113883.6.96"/>
                                                        <ItemData ItemOID="MHONG" value="RESOLVED"/>
                                                        <ItemData ItemDataOID="MHSTDTC" value="199701"/>
                                                </ItemGroupData>
                                                <ItemGroupData ItemGroupOID="CONDITION">
                                                        <ItemData ItemOID="MHTERM" value="Pneumonia"
xsi:type="CD" code="233604007" codeSystem="2.16.840.1.113883.6.96"/>
                                                        <ItemData ItemOID="MHONG" value="RESOLVED"/>
                                                        <ItemData ItemDataOID="MHSTDTC" value="199903"/>

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                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="CONDITION">
                                                      <ItemData ItemOID="MHTERM" value="Myocardial
infarction" xsi:type="CD" code="22298006" codeSystem="2.16.840.1.113883.6.96"/>
                                                      <ItemData ItemOID="MHONG" value="RESOLVED"/>
                                                      <ItemData ItemDataOID="MHSTDTC" value="199701"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="PROCEDURE">
                                                      <ItemData ItemOID="MHTERM" value="Total hip
replacement, left"/>
                                                      <ItemData ItemDataOID="MHONG" value="RESOLVED"/>
                                              </ItemGroupData>
                                      </FormData>
                                      <FormData FormDataOID="ConMedForm">
                                              <ItemGroupData ItemGroupOID="CM">
                                                      <ItemData ItemDataOID="CMTRT" value="Albuterol
inhalant"/>
                                                      <ItemData ItemDataOID="CMROUTE" value="Inhalation,
oral"/>
                                                      <ItemData ItemDataOID="CMINDC" value="Wheezing"
xsi:type="CE" code="56018004" codeSystem="2.16.840.1.113883.6.96"/>
                                                      <ItemData ItemDataOID="CMDSTXT" value="2"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="CM">
                                                      <ItemData ItemDataOID="CMTRT" value="Clopidogrel"/>
                                                      <ItemData ItemDataOID="CMDSTXT" value="1"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="CM">
                                                      <ItemData ItemDataOID="CMTRT" value="Metoprolol"/>
                                                      <ItemData ItemDataOID="CMDSTXT" value="1"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="CM">
                                                      <ItemData ItemDataOID="CMTRT" value="Prednisone"/>
                                                      <ItemData ItemDataOID="CMSTDTC" value="20000328"/>
                                                      <ItemData ItemDataOID="CMDSTXT" value="1"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupOID="CM">
                                                      <ItemData ItemDataOID="CMTRT" value="Cephalexin"/>
                                                      <ItemData ItemDataOID="CMSTDTC" value="20000328"/>

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                                                            <ItemData ItemDataOID="CMENDDTC" value="20000404"/>
                                                            <ItemData ItemDataOID="CMDSTXT" value="1"/>
                                                    </ItemGroupData>
                                            </FormData>
                                            <FormData FormDataOID="VSForm">
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="19991114"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Body height"/>
                                                            <ItemData ItemDataOID="VSORRES" value="177"/>
                                                            <ItemData ItemDataOID="VSORRESU" value="cm"/>
                                                    </ItemGroupData>
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="19991114"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Body weight"/>
                                                            <ItemData ItemDataOID="VSORRES" value="86"/>
                                                            <ItemData ItemDataOID="VSORRESU" value="kg"/>
                                                    </ItemGroupData>
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="19991114"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Systolic BP"/>
                                                            <ItemData ItemDataOID="VSORRES" value="132"/>
                                                            <ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
                                                    </ItemGroupData>
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="19991114"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Diastolic BP"/>
                                                            <ItemData ItemDataOID="VSORRES" value="86"/>
                                                            <ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
                                                    </ItemGroupData>
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="20000407"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Body height"/>
                                                            <ItemData ItemDataOID="VSORRES" value="177"/>
                                                            <ItemData ItemDataOID="VSORRESU" value="cm"/>
                                                    </ItemGroupData>
                                                    <ItemGroupData ItemGroupDataOID="VS">
                                                            <ItemData ItemDataOID="VSDTC" value="20000407"/>
                                                            <ItemData ItemDataOID="VSTEST" value="Body weight"/>
                                                            <ItemData ItemDataOID="VSORRES" value="88"/>

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                                                      <ItemData ItemDataOID="VSORRESU" value="kg"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="VS">
                                                      <ItemData ItemDataOID="VSDTC" value="20000407"/>
                                                      <ItemData ItemDataOID="VSTEST" value="Systolic BP"/>
                                                      <ItemData ItemDataOID="VSORRES" value="145"/>
                                                      <ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="VS">
                                                      <ItemData ItemDataOID="VSDTC" value="20000407"/>
                                                      <ItemData ItemDataOID="VSTEST" value="Diastolic BP"/>
                                                      <ItemData ItemDataOID="VSORRES" value="88"/>
                                                      <ItemData ItemDataOID="VSORRESU" value="mm[Hg]"/>
                                              </ItemGroupData>
                                      </FormData>
                                      <FormData FormDataOID="AEForm">
                                              <ItemDataGroup ItemDataGroupOID="AE">
                                                      <ItemData ItemDataOID="AETERM" value="Penicillin"/>
                                              </ItemDataGroup>
                                              <ItemDataGroup ItemDataGroupOID="AE">
                                                      <ItemData ItemDataOID="AETERM" value="Aspirin"/>
                                              </ItemDataGroup>
                                              <ItemDataGroup ItemDataGroupOID="AE">
                                                      <ItemData ItemDataOID="AETERM" value="Codeine"/>
                                              </ItemDataGroup>
                                      </FormData>
                                      <FormData FormDataOID="LBForm">
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200003231430"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="107c2dc0-67a5-
11db-bd13-0800200c9a66" code="30313-1" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="HGB"/>
                                                      <ItemData ItemDataOID="LBORRES" value="13.2"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="g/dl"/>
                                                      <ItemData ItemDataOID="LBNRIND" value="N"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>

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                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200003231430"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="8b3fa370-67a5-
11db-bd13-0800200c9a66" code="33765-9" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="WBC"/>
                                                      <ItemData ItemDataOID="LBORRES" value="6.7"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="10+3/ul"/>
                                                      <ItemData ItemDataOID="LBORNRLO" value="4.3"/>
                                                      <ItemData ItemDataOID="LBORNRHI" value="10.8"/>
                                                      <ItemData ItemDataOID="LBNRIND" value="N"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200003231430"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="80a6c740-67a5-
11db-bd13-0800200c9a66" code="26515-7" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="PLT"/>
                                                      <ItemData ItemDataOID="LBORRES" value="123"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="10+3/ul"/>
                                                      <ItemData ItemDataOID="LBORNRLO" value="150"/>
                                                      <ItemData ItemDataOID="LBORNRHI" value="350"/>
                                                      <ItemData ItemDataOID="LBNRIND" value="L"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200004061300"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="a40027e1-67a5-
11db-bd13-0800200c9a66" code="2951-2" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="NA"/>
                                                      <ItemData ItemDataOID="LBORRES" value="140"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="meq/l"/>
                                                      <ItemData ItemDataOID="LBORNRLO" value="135"/>
                                                      <ItemData ItemDataOID="LBORNRHI" value="145"/>

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                                                             <ItemData ItemDataOID="LBNRIND" value="N"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200004061300"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="a40027e2-67a5-
11db-bd13-0800200c9a66" code="2823-3" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="K"/>
                                                      <ItemData ItemDataOID="LBORRES" value="4.0"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="meq/l"/>
                                                      <ItemData ItemDataOID="LBORNRLO" value="3.5"/>
                                                      <ItemData ItemDataOID="LBORNRHI" value="5.0"/>
                                                      <ItemData ItemDataOID="LBNRIND" value="N"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200004061300"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="a40027e3-67a5-
11db-bd13-0800200c9a66" code="2075-0" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="CL"/>
                                                      <ItemData ItemDataOID="LBORRES" value="102"
xsi:type="PQ"/>
                                                      <ItemData ItemDataOID="LBORRESU" value="meq/l"/>
                                                      <ItemData ItemDataOID="LBORNRLO" value="98"/>
                                                      <ItemData ItemDataOID="LBORNRHI" value="106"/>
                                                      <ItemData ItemDataOID="LBNRIND" value="N"
codeSystem="2.16.840.1.113883.5.83"/>
                                              </ItemGroupData>
                                              <ItemGroupData ItemGroupDataOID="LB">
                                                      <ItemData ItemDataOID="LBDTC" value="200004061300"/>
                                                      <ItemData ItemDataOID="LBSTAT" value="completed"/>
                                                      <ItemData ItemDataOID="LBREFID" value="a40027e4-67a5-
11db-bd13-0800200c9a66" code="1963-8" codeSystem="2.16.840.1.113883.6.1"/>
                                                      <ItemData ItemDataOID="LBTEST" value="HCO3"/>
                                                      <ItemData ItemDataOID="LBORRES" value="35"
xsi:type="PQ"/>

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                                                                <ItemData   ItemDataOID="LBORRESU" value="meq/l"/>
                                                                <ItemData   ItemDataOID="LBORNRLO" value="18"/>
                                                                <ItemData   ItemDataOID="LBORNRHI" value="23"/>
                                                                <ItemData   ItemDataOID="LBNRIND" value="H"
codeSystem="2.16.840.1.113883.5.83"/>
                                                 </ItemGroupData>
                                         </FormData>
                                 </StudyEventData>
                         </SiteRef>
                 </SubjectData>
         </ClinicalData>
</ODM>
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Draft v.1 IHE Quality, Research & Public Health Domain Technical CommitteePage 54 of 54
                                                          12/30/2011

				
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