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WarehouseInvestigatorInfo by wuzhengqin

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									                           CTSC Data Warehouse
                        Information for Investigators
                                  Revised 6/24/2009




I. Overview

The Clinical Translational Science Center (CTSC) at the University of New Mexico
Health Sciences Center (UNM HSC) has a number of initiatives in Biomedical
Informatics (BMI), of which this is one. The CTSC has created a Clinical Data
Warehouse in cooperation with TriCore Reference Laboratories. Partners include the
New Mexico Veteran’s Administration Health Care System (NMVAHCS), and HSC
Information Solutions. The purpose of this distributed, virtual data repository is to
provide clinical, diagnostic, and outcome data and data-mining services to support
clinical and translational research that is intended for extramural support. Most approved
studies will not be initially charged a fee. However, larger or more work intensive
projects may be required to pay a fee.


II. Approved Uses of the Data
     A. Activities Preparatory to Research
     These queries do not lead to generalizable knowledge, and cannot be used for
     presentations or publication. They are not considered research and do not require
     HRRC approval. Their results may be cited in grant proposals and applications.
     Three types of preparatory activities pertain.
           1) Feasibility Studies
           These queries determine the number and location of patients who meet study
           criteria. They can be used to estimate the level of effort needed for
           recruitment. Confirmation of feasibility improves the chances of funding.
           2) Sample Size Estimation
           Where suitable data is available, it can be analyzed by data warehouse staff to
           provide investigators with descriptive statistics summarizing results.
           Investigators must prepare a written justification and show that HIPAA
           requirements are met. Only aggregated, de-identified information is provided.
           3) Characterization of Source Data
           De-identified sample data may be provided to assist in determining the format,
           data type, units of measurement, and data structure of available records.

       B. Database Studies
       These queries are used to generate descriptive statistics or to test hypotheses
       through cohort studies analysis or by regressing on exposures. Analysis is done




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    on de-identified records. Proposals must be submitted to CTSC and HRRC but
    are usually exempted from review by the latter.

    C. Recruiting Patients
    The CTSC Data Warehouse will offer this service at a later time. It is not
    currently available due to resource limitations. (See below: Data Warehouse
    Contents, Future Planned Offerings). When it becomes available, investigators
    will need to include a waiver of consent and a HIPAA addendum with their
    HRRC application, in addition to informed consent and HIPAA authorization for
    the actual study.


III. Application Procedures
   A. Intake Interview (recommended)
   Investigators should avail themselves of the opportunity to discuss their data needs
   with the CTSC’s BMI Specialist prior to submitting an application. This is
   especially important if they do not have a detailed familiarity with the structure or
   format of available data. Please contact Laurie McPherson at
   lmcpherson@salud.unm.edu or 925-4123.

   B. Application Forms

          Please complete the Data Request and the Data Use/Transfer agreement.

   When submitting it, please attach copies of the protocol, HRRC approval, research
   informed consent or waiver, and HIPAA authorization or waiver. (With activities
   preparatory to research, such documentation does not apply.)

   Submission may be by hand delivery, fax transmission, by emailing a PDF, or via
   postal mail to:

      Laurie McPherson
      Biomedical Informatics Specialist
      Clinical & Translational Science Center (CTSC)
      University of New Mexico Health Sciences Center
      MSC08 4560
      1 University of New Mexico
      Albuquerque, NM 87131-0001

      Fax:   (505) 272-9675
      Phone: (505) 925-4123
      Email: lmcpherson@salud.unm.edu




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   C. Review of Applications
   Requests for research data will be subject to review and approval by the CTSC’s
   BMI Data Warehouse Sub-committee, and by the designated authority at TriCore or
   other cooperating data repository. Normally this process would take place within
   one week but for sensitive or complex requests may take up to two weeks. . If the
   request is deemed problematic the investigator would be contacted with an
   explanation within the same period and provided with assistance in re-defining the
   request.In addition, HRRC approval or exemption will be verified. (See Figure 1.)

   Figure 1. How to get data from the CTSC data warehouse

                                Application Procedures
           for Support from the CTSC Clinical Research Data Warehouse


         Intake interview       Investigator
                                                              BMIS* reviews
            with BMIS          submits signed
                                                               application
         (recommended)           application



                                  Queries preparatory
                                  to research                  Review by
                                                             CTSC Data W/H
                                                               Committee
                                                        Other
                                                        queries



                                           Verification                     Review by
                                            of HRRC                       data provider(s)
                                            approval                        e.g. TriCore




                                                                 BMIS *                     Investigator
                                                            prepares minimum               retrieves data
                                                                 data set               from secure location




          * BMIS = Biomedical Informatics Specialist (Laurie McPherson)




IV. Data Handling Procedures
   A. Distribution of the Data
   Completely de-identified data such as a single aggregate count may be distributed
   in a non-secure manner. All other approved data requests will be fulfilled via
   distribution in a secured private location. This will be accomplished by means of
   creation of restricted folder on the HSC network. Drive mappings will be provided
   to this area. To facilitate audit controls, folders will be named with last name of the
   principal investigator and with the HRRC number. Only the BMI Specialist, the PI
   and designated members of his or her research team will be granted permissions to


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this folder. Such individuals will be named in the application process (see Data Use
Agreement). Written notification should be provided to the BMI Specialist to
revoke such permissions due to staff turnover, etc., or to request that new persons
be added. HSC and UH Help Desks will be instructed NOT to handle permissions
for this network area.

Only minimum data necessary to satisfy approved requests will be released and it
will be de-identified to the maximum extent possible that still meet demonstrated
and approved study needs. If approved, data sets may contain protected health
information (PHI). Medical record numbers (MRNs) will not be provided, but will
replaced with randomized study numbers to which the BMIS will retain the key.


B. Protection from Loss

The following restrictions will apply to the use and storage of the data provided by
the CTCS Clinical Research Data Warehouse,

   Files will reside on HSC computer systems, queried only through HSC work
    stations, and accessed only by software approved for HSC use.
   Downloading of files containing PHI to laptops, external storage devices
    (floppies, compact discs, zip drives, thumb drives, etc.), or the hard drive or desk
    tops of institutional computers is strictly prohibited.
   Accessing files from remote computers is strictly prohibited except where an
    encrypted, institutionally-approved Virtual Private Networking is employed.
   No file containing PHI will be transmitted across the Internet, through the
    Intranet, or through any form of e-mail at any time.
   All hardcopy reports containing PHI will be stored in locked filing cabinets in
    locked offices in accordance with standard research policy. No such documents
    will be transferred off-site. All paper records will be kept only for as long as
    required by applicable regulations and then disposed of in a secured manner.
   Viewing of must be done through private work stations in locked rooms.
    Accessing programs or files through work stations in common use areas such as
    clinics is prohibited.
   All printing tasks must be sent to local printers in the same room as the work
    station.




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      Creating “short-cuts” to files maintained by the CTSC Data Warehouse is
       prohibited.
      All other institutional policies must be strictly followed, including prohibitions on
       sharing passwords or accessing protected files of another person.

   C. Termination Procedures
   The principal investigator is responsible for notifying the BMI Specialist when data
   supplied by the CTS is no longer needed for the research project. This notification
   will include the minimum retention period after the completion of a protocol. Any
   documentation required by the HIPAA Privacy Rule must be retained for 6 years
   from when it was last in effect.


V. Data Warehouse Contents
  A. Current Offerings
  Currently we offer three years of TriCore data representing all labs on all UNM
  patients. By the end of 2009 this is anticipated to expand to include seven years of
  data, or records from 2002 to the present. The data is structured according to Figure 2.

  Figure 2. TriCore Data Tables


                           TriCore Reference Laboratories


                  Patients
                  • Name, DOB, sex                      Tests
                  • Address, city, state, zip           • Test name, method
                  • MRN from Cerner                     • Containers/child containers
                                                        • Callback codes
                  Episodes                              • CPT codes
                  • Admission/discharge dates
                  • Clinic/ward/room locations
                                                        Results
                                                        • Tracking data (timestamps,
                  Accessions                              priority, sensitivity, finality)
                  • Tests/test batteries ordered        • Result code (summative)
                  • Ordering/copy-to physicians         • Result (descriptive text)
                  • Patient location/age at order




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B. Future Planned Offerings

   1) Other UNM Data
   Arrangements are currently underway to create linkages with additional data
   derived from billing data for professional services through the UNM Medical
   Group (UNMMG). Such data links easily to laboratory data based on their
   shared medical record number (MRN). (See Figure 3.)

   Figure 3. IDX Billing Data for UNM Patients




   2) VA data
   For investigators willing to undertake the process of acquiring credentials with
   the Veterans Administration (VA), the data warehouse of the NMVAHCS will
   also be made available. The necessary credentials are a “Without
   Compensation” appointment (WOC). Please allow approximately one month
   for WOC processing and expect at least four hours of investigator effort.
   Additional restrictions apply to VA data, and no mechanisms are yet available
   to merge it with TriCore or UNM data. However as a free-standing data set it
   is exceptionally rich and complete. (See Figure 3).




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Figure 3. VA Data

                                      NMVAMC
                                   Data Warehouse

          Patients
          Identified data strictly segregated   Visits


          Labs                                  Vital Signs
          Done in-house (no Tricore)

                                                Medications
          Discharge Diagnoses
                                                Dispensed and prescribed
          ICD-9 codes

                                                Problem List
          Procedures
                                                No comparable UNM data
          CPT codes




3) Patient Recruitment
Another exciting area of planned expansion is an “Honest Broker” service to
provide recruitment services of identified patients pre-selected to meet
specific criteria for clinical trials. Data warehouse resources provide a rich
source for unbiased selection of such individuals. In accordance with
guidelines of the Human Research Review Committee (HRRC), pre-approval
is sought by the honest broker from primary care providers, and patients
approved are then solicited under the provider’s signature. Patients
responding affirmatively are compiled by the honest broker and their
information forwarded to the researcher.

This service will become available at a later date as funding and personnel
permit. Fees will likely be charged for this service, and investigators should
plan their budgets accordingly.



Thank you for your interest in the CTSC Clinical Data Warehouse.

                      For question, please contact
                      lmcpherson@salud.unm.edu




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