] Clinical Trial Management System Working Group

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Clinical Trial Management System Working Group Meeting City of Hope National Medical Center Joyce C. Niland, PhD Chair, Information Sciences February 19, 2004 Development Team           Dr. Joyce Niland Dr. Doug Stahl Dr. David Ikle Dr. Hemant Shah Cindy Stahl Joycelynne Palmer Amy Cox Stacy Berger Tremon White Tuong Tieu Chair, Information Sciences Director, Biomedical Informatics Associate Director, Biostatistics Information Scientist Systems Analyst Systems Analyst Systems Analyst Database Architect Application Developer Application Developer Outline of Today’s Talk  Past Experience in Clinical Research System Development Current Approach: Fully Integrated Research Standards & Technology (FIRST) Proposed Future Approach: Year One   City of Hope’s Experience in Clinical Trials System Development Research Protocol Lifecycle Research Idea Protocol Tracking Results Outcomes Data Eligibility Screening Patient Tracking Protocol Monitoring City of Hope Experience in Clinical Research System Development and Deployment Computerized System Biostatistics Information Tracking System (BITS) Frozen Tumor Bank Specimen Tracking System NCCN Web-based Outcomes Research System Forms Tracking System Clinical Trials On-Line Protocol Delivery System Year Deployed 1989 1992 1996 1997 1998 Clinical Pathways Patient Management System Web-enabled Genotype-Phenotype Database Guideline Graphical Decision Support Interface GCRC Protocol & Patient Administrative System Web-based Services for Protocol Data Integration Metadata Repository System *Prototype 1999 2000 2001 2002 2002* 2003* Clinical Trials System at COH  Over 400 ongoing trials at City of Hope – – – 30-40% of COH patients enroll on one or more trials 1/3 pharma, 1/3 cooperative group, 1/3 intramural Data Coordinating Center for ~60 multi-center trials  Created centralized clinical trials database – – – – – Biostatistics Information Tracking System (BITS) In continual use for all COH trials since 1989 Over 500,000 records on more than 20,000 patients Migrated to MS SQL server, building web interfaces Also deploying scannable forms BITS & Clinical Trials On-Line support: >400 clinical trials >110 investigators Features of BITS  Protocol accessions, demographics, labs, and relapse survival on all patients  Detailed case report form (CRF) data for patients on in-house trials  Export to NCI CDUS application  Mirrored copy of Oacis to import     A2K demographics Sunquest labs Cytogenetics HLA data Deployed for all Pediatric protocol patients Clinical Pathways System Lessons Learned.... Architecture must support within trial and cross-protocol analyses Study-Specific Model for: T T T T T T R R R R R R I I I I I Case Iseries, outcomes research, A A A A A A meta analysis, data mining L L L L L L 1 2 3 4 5 6 Unified Data Model for: All Clinical Trial and Case Series, outcomes research, Observational meta analysis, data mining Study Data Lessons Learned….  „Metadata‟ are critical!  Data about the data themselves   Technical directory: system perspective Business directory: user perspective  Required for critical database functionality:      Merging in legacy electronic data Data directory to facilitate data mining Management of data derivation and logic rules Preparing summary versions of massive data sets („data marts‟) Documenting creation and “sunset” dates of data elements & codes Creation of an Effective Metadata Repository  Building an interactive Web-based metadata repository (ISO/IEC 11179 compliant)    Will be the “driver” of future systems Technical metadata populated from „feeder‟ systems Detailed analysis of business metadata of all fields underway by full-time Metadata Analyst Root Cause of Data Management and Integration Problems  Lack of a unified information architecture  Requires standard  Data model  Vocabularies  Data interfaces  Improved information technology infrastructure and tools needed to exploit significant investments in biomedical data  Formidable task  Becomes more intractable and costly as time goes on FIRST: Fully Integrated Research Standards & Technology FIRST   3-year GCRC supplement grant funded by the NCRR Goal: Develop a fully integrated information management and decision support environment   Facilitate all phases of clinical research Support research infrastructure of the GCRCs  Development group: COH Division of Information Sciences   Input and testing from USC and CHLA Collaboration with Dr. David Forslund, Advanced Computing Lab, Los Alamos National Laboratory Objectives of FIRST  Create a clinical research environment to support the wide range of clinical research activities across the protocol life cycle  Bring together enabling technologies:  Standardized information modeling  Object-oriented distributed architecture  Advanced graphical user interfaces  Ultimate goal: scalable interoperable system caBIG ‘Desiderata’  Open access, open source  Derived from common information models  Standards for data exchange formats  Data and metadata following ISO/IEC 11179  Consume appropriate public, open access standards when available All of these principles are being followed in FIRST Through FIRST…  A common standardized UML model for clinical research will be made publicly available mapping among vocabularies  Semantic analysis will yield common standards and   Integration of existing data sources will be facilitated Prototype applications that support the clinical research life cycle are being developed and tested Functionality to be Supported in FIRST Research Idea Protocol Tracking Results Outcomes Data Eligibility Screening Patient Tracking Protocol Monitoring Principles in Developing FIRST  Computational and semantic standards  Information integration  System interoperability  Workgroup collaboration Sufficiently flexible methods to:  Scale over time  Adapt to unanticipated needs  Accommodate multiple disease entities  Adopt to different research environments  Exploit major advances in science and technology  FIRST Unifying Information Architecture  Enforce both technological and lexical standards through:    Standardized Data Model Semantic Standards Technical Interoperability FIRST Schematic Diagram FIRST Modeling Process Standardized Data Model  Requires clear understanding of the environment  FIRST Advisory Group of senior investigators  Clinical trialists, biostatisticians, research staff, informaticists Originally envisioned “units of application functionality” as shown in protocol life cycle  Actual components of model far less orderly, organized, and separated in practice   Much time and effort required to:  Separate, document, and specify units of application functionality  Define interrelationships sufficiently begin application development 30,000 Foot View of FIRST Information Model Protocol Status: Registration Conditions met, N slots available N–1 Slots Available Reported SAE First Study Participant Status: Eligibility Filtering Eligibility Screening Consenting Processes Accessioning Processes Treatment SAE ... Data Collection Process: Eligibility Checklist Consent Form Form A Form B Form C SAE Form FIRST Modeling Process  Requirements analysis and documentation conducted in a uniform manner  Unified Modeling Language (UML)-based clinical research domain model  Maintains consistency among model, metadata,and technology  Assures architectural soundness  Improves communication between domain & technical experts  Facilitates translation into an executable program  Promotes platform independence  City of Hope members of HL7 working group  Expert consultant: Gunther Schadow, Regenstrief Institute Eligibility Filtering Use Case Use Case 20.0 Protocol Abstraction for Eligibility Filtering Description The protocol abstractor entered data about the protocols eligibility and exclusion criteria into the system. Actor Protocol Abstractor System Pre-Conditions Protocol is registered into the system. Basic Course .The actor has logged into the system (See Use Case 1.0), searched and selected the desired protocol (See Use Case10.0) (example screen # 3) .The system displays a page (example screen # 4) that allows the actor to select „Eligibility Criteria‟ within the „Protocol Abstraction‟ function. .The system displays the protocol abstraction – eligibility filtering criteria page (example screen #22, #27, #23, #32). The following information is requested about the protocols eligibility and exclusion criteria. All criteria are required. NA is used if the protocol does not specify. Gender* (^Alternate Course 8.0.3 Add a value to any of the pick lists) Minimum age and unit* Maximum age and unit* Functional status* Minimum life expectancy* Disease* HL7 RIM 2.01 Class Diagram Organization addr : BAG standardIndustryClassCode : CE Place mobileInd : BL addr : AD directionsText : ED positionText : ED gpsText : ST Patient confidentialityCode : CE veryImportantPersonCode : CE ManagedParticipation id : SET statusCode : SET ActRelationship typeCode : CS inversionInd : BL outboundRelationship contextControlCode : CS Access LicensedEntity 0..n contextConductionInd : BL approachSiteCode : CD sequenceNumber : INT recertificationTime : TS Person targetSiteCode : CD 1 source priorityNumber : INT gaugeQuantity : PQ addr : BAG pauseQuantity : PQ Act Participation maritalStatusCode : CE checkpointCode : CS classCode : CS Entity educationLevelCode : CE typeCode : CS splitCode : CS moodCode : CS Role raceCode : SET functionCode : CD classCode : CS player joinCode : CS id : SET disabilityCode : SET classCode : CS contextControlCode :... CS determinerCode : CS negationInd : BL 0..1 code : CD 0..n id : SET livingArrangementCode : CE sequenceNumber : INT 0..n id : SET conjunctionCode : CS negationInd : BL 1 religiousAffiliationCode : CE playedRole code : CE negationInd : BL code : CE localVariableName : ST 1 derivationExpr : ST ethnicGroupCode : SET negationInd : BL quantity : SET 0..n noteText : ED seperatableInd : BL text : ED addr : BAG time : IVL name : BAG inboundRelationship 0..n title : ST telecom : BAG modeCode : CE desc : ED statusCode : SET target awarenessCode : CE statusCode : SET scopedRole statusCode : SET LivingSubject effectiveTime : GTS effectiveTime : IVL signatureCode : CE existenceTime : IVL ... 1 0..n certificateText : ED activityTime : GTS administrativeGenderCode : CE signatureText : ED telecom : BAG 0..1 availabilityTime : TS birthTime : TS quantity : RTO source performInd : BL riskCode : CE ControlAct scoper deceasedInd : BL positionNumber : LIST ... 1 substitutionConditionCode : CEpriorityCode : SET ... handlingCode : CE confidentialityCode : SET ... deceasedTime : TS 1 target repeatNumber : IVL multipleBirthInd : BL 1 interruptibleInd : BL multipleBirthOrderNumber : INT WorkingList levelCode : CE Employee organDonorInd : BL outboundLink 0..n FinancialContract ownershipLevelCode : CE independentInd : BL 0..n jobCode : CE paymentTermsCode : CE RoleLink uncertaintyCode : CE jobTitleName : SC Material inboundLink typeCode : CS reasonCode : SET NonPersonLivingSubject jobClassCode : CE effectiveTime : IVL ... formCode : CE languageCode : CE salaryTypeCode : CE strainText : ED InvoiceElement salaryQuantity : MO genderStatusCode : CE hazardExposureText : ED modifierCode : SET SubstanceAdministration protectiveEquipmentText : ED Observation unitQuantity : RTO ManufacturedMaterial routeCode : CE 0..n unitPriceAmt : RTO value : ANY lotNumberText : ST approachSiteCode : SET netAmt : MO LanguageCommunication interpretationCode : SET expirationTime : IVL doseQuantity : IVL Procedure factorNumber : REAL methodCode : SET stabilityTime : IVL rateQuantity : IVL languageCode : CE methodCode : SET pointsNumber : REAL doseCheckQuantity : SET targetSiteCode : SET modeCode : CE approachSiteCode : SET maxDoseQuantity : SET proficiencyLevelCode : CE targetSiteCode : SET preferenceInd : BL Device Account DiagnosticImage manufacturerModelName : SC name : ST subjectOrientationCode : CE softwareName : SC Container balanceAmt : MO localRemoteControlStateCode : CE ... PatientEncounter capacityQuantity : PQ currencyCode : CE PublicHealthCase alertLevelCode : CE Supply heightQuantity : PQ interestRateQuantity : RTO admissionReferralSourceCode : CE transmissionModeCode : CE expectedUseTime : IVL capTypeCode : CE lengthOfStayQuantity : PQ diseaseImportedCode : CE RIM 2.01 separatorTypeCode : CE dischargeDispositionCode : CE FinancialTransaction barrierDeltaQuantity : PQ specialCourtesiesCode : SET July 17,2003 Diet DeviceTask bottomDeltaQuantity : PQ amt : MO specialAccommodationCode : SET energyQuantity : PQ parameterValue : LIST creditExchangeRateQuantity : REAL acuityLevelCode : CE carbohydrateQuantity : PQ debitExchangeRateQuantity : REAL HL7 Reference Information Model (RIM 2.01) Backbone ActRelationship typeCode : CS inversionInd : BL outboundRelationship contextControlCode : CS 0..n contextConductionInd : BL sequenceNumber : INT 1 source priorityNumber : INT pauseQuantity : PQ Act Participation checkpointCode : CS classCode : CS typeCode : CS splitCode : CS moodCode : CS functionCode : CD joinCode : CS id : SET contextControlCode : ... CS negationInd : BL code : CD sequenceNumber : INT 0..n conjunctionCode : CS negationInd : BL 1 negationInd : BL localVariableName : ST 1 derivationExpr : ST 0..n noteText : ED seperatableInd : BL text : ED time : IVL inboundRelationship 0..n title : ST modeCode : CE statusCode : SET awarenessCode : CE effectiveTime : GTS signatureCode : CE activityTime : GTS signatureText : ED availabilityTime : TS performInd : BL priorityCode : SET substitutionConditionCode : CE confidentialityCode : SET repeatNumber : IVL target interruptibleInd : BL levelCode : CE independentInd : BL uncertaintyCode : CE Entity Role classCode : CS player classCode : CS determinerCode : CS 0..1 0..n id : SET id : SET playedRole code : CE code : CE negationInd : BL quantity : SET addr : BAG name : BAG telecom : BAG desc : ED statusCode : SET scopedRole statusCode : SET effectiveTime : IVL existenceTime : IVL ... 0..n certificateText : ED telecom : BAG 0..1 quantity : RTO riskCode : CE scoper handlingCode : CE HL7 Block Diagram Entity Act classCode*: <= ACT moodCode*: <= EVN 0..* participant id: SET [0..*] 0..*participant / participation scopedRole code: CD CWE [0..1] <= ActCode Role typeCode*: <= ParticipationType negationInd: BL [0..1] classCode*: <= ROL functionCode: CD CWE [0..1] <= ParticipationFunction derivationExpr: ST [0..1] id: SET [0..*] contextControlCode: CS CNE [0..1] <= ContextControl text: ED [0..1] code: CE CWE [0..1] <= RoleCode sequenceNumber: INT [0..1] statusCode: SET CNE [0..*] <= ActStatus negationInd: BL [0..1] negationInd: BL [0..1] effectiveTime: GTS [0..1] addr: BAG [0..*] noteText: ED [0..1] activityTime: GTS [0..1] telecom: BAG [0..*] time: IVL [0..1] availabilityTime: TS [0..1] statusCode: SET CNE [0..*] <= RoleStatus modeCode: CE CWE [0..1] <= ParticipationMode priorityCode: SET CWE [0..*] <= ActPriority effectiveTime: IVL [0..1] awarenessCode: CE CWE [0..1] <= TargetAwareness confidentialityCode: SET CWE [0..*] <= Confidentiality certificateText: ED [0..1] signatureCode: CE CNE [0..1] <= ParticipationSignature repeatNumber: IVL [0..1] quantity: RTO [0..1] signatureText: ED [0..1] interruptibleInd: BL [0..1] positionNumber: LIST [0..*] 0..* playedRole performInd: BL [0..1] levelCode: CE CWE [0..1] <= ActContextLevel 0..* act independentInd: BL [0..1] 0..1 playingEntity uncertaintyCode: CE CNE [0..1] <= ActUncertainty Entity reasonCode: SET CWE [0..*] <= ActReason languageCode: CE CWE [0..1] <= HumanLanguage classCode*: <= ENT determinerCode*: <= INSTANCE 0..* source sourceOf / id: SET [0..*] targetOf code: CE CWE [0..1] <= EntityCode typeCode*: <= ActRelationshipType quantity: SET [0..*] inversionInd: BL [0..1] name: BAG [0..*] contextControlCode: CS CNE [0..1] <= ContextControl desc: ED [0..1] contextConductionInd: BL [0..1] statusCode: SET CNE [0..*] <= EntityStatus sequenceNumber: INT [0..1] existenceTime: IVL [0..1] priorityNumber: INT [0..1] telecom: BAG [0..*] pauseQuantity: PQ [0..1] riskCode: CE CWE [0..1] <= EntityRisk checkpointCode: CS CNE [0..1] <= ActRelationshipCheckpoint handlingCode: CE CWE [0..1] <= EntityHandling splitCode: CS CNE [0..1] <= ActRelationshipSplit joinCode: CS CNE [0..1] <= ActRelationshipJoin negationInd: BL [0..1] conjunctionCode: CS CNE [0..1] <= RelationshipConjunction localVariableName: ST [0..1] seperatableInd: BL [0..1] 0..1 scopingEntity 0..* target Act FIRST Block Diagram: Protocol Registration Performer Protocol classCode*: <= ACT moodCode*: <= DEF id: SET [0..*] code: CD CWE [0..1] <= ActCode title: ST [0..1] text: ED [0..1] statusCode*: SET CNE [0..*] <= ActStatus effectiveTime: GTS [0..1] typeCode*: <= PRF functionCode: CD CWE [0..1] <= ParticipationFunction "SitePrincipalInvestigator" FIRST Block Diagram - Protocol Registration Institution ClinicalResearchInvestigator classCode*: <= CRINV id: SET [0..*] code: CE CWE [0..1] <= RoleCode addr: BAG [0..*] telecom: BAG [0..*] statusCode: SET CNE [0..*] <= RoleStatus effectiveTime: IVL [0..1] classCode*: <= ORG determinerCode*: <= INSTANCE Person classCode*: <= PSN determinerCode*: <= INSTANCE name: Distributer typeCode*: <= DIST functionCode: CD CWE [0..1] <= ParticipationFunction "PrimarySponsor" Sponsor classCode*: <= CRSPNSR Organization classCode*: <= ORG determinerCode*: <= INSTANCE InformationOriginator typeCode*: <= ParticipationInformationGenerator SponsorProtocolInformation classCode*: <= CNTRCT moodCode*: <= DEF Component typeCode*: <= COMP Component2 typeCode*: <= COMP sponsorProtocolId classCode*: <= CNTRCT moodCode*: <= DEF id: SET [0..*] title: ST [0..1] sponsorProtocolVersion classCode*: <= CNTRCT moodCode*: <= DEF effectiveTime: GTS [0..1] FIRST Semantic Standards No Single Vocabulary Can Meet All Needs  More than one vocabulary system required for FIRST   SNOMED, LOINC, RX-NORM caDSR Common Data Elements (CDEs)  External standards can be represented as CDEs (e.g. ICD-O-3)  Still may need to additional terms/concepts  Utilize UMLS to search for terms UMLS for Mapping Across Terms and Concepts Vocab. Source A Concept 1 Term 1 Term 1 UMLS Metathesaurus Concept 1 Concept 2 Term 2 Term 2 Concept 2 Vocab. Source B Concept 3 Term 3 Concept 4 Term 4 Term 3 Concept 4 Term 4 Without proper metadata… Sample Master Data Elements Source Primary Sponsor Protocol Version (Protocol Version) A protocol identifier assigned to represent the variation of the protocol produced by one or more amendment. The month, day, and year that the most recent version of the protocol was documented. HL7 Ref 3,5,7,8,9,1 Sponsor Ver 1 Num FIRST ST 2.8.40 NA Also Current Version Number, Prot Vers, VERSION, VERSION_NO, Version No, & Version Number (FIRST). Primary Sponsor Protocol Version Date (Protocol Version Date) VERSION_DT, VERSION_DT _CUR, or 5,7,8,11 Version Date FIRST DT 2.8.15 NA Primary Sponsor Protocol Status (Protocol status) Primary Sponsor Protocol Status Date (Protocol status date) Primary Sponsor Next Review Date 11 Sponsor Status RCRIM 11 SPONSOR_S T_DT FIRST no definition The month, day, and year that the current sponsor status became effective. The date that the next review is scheduled. CE 2.8.3 NA DT 2.8.15 NA Also Current Version Date or Prot Vers Dt (FIRST). Also CURRENT_PROTOC OL_STATUS (CTEP 2.31 - draft/new) - no definition OR Current Sponsor Status, SPONSOR_ST, & Protocol Status from FIRST. Also Protocol Status Date, or Date of Current Sponsor Status (FIRST). REVIEW_DT FIRST DT 2.8.15 NA repeat contact person for 'Other Sponsor'; Review Board; Review Committee; Regulatory Agency; Multi-Center Consortium; Funding Agency; Granting Agency Contact Person 16 CTEP 4.0 The name of the CONTACT_PE (appr for contact person at an RSON_NAME trial) institution. XPN 2.8.51 NA FIRST Technologies FIRST Technologies Object Management Group (OMG) International Standards Organization Develops technically integrated, commercially viable, vendor independent specifications for software industry Achieved international consensus on Common Object Request Broker Architecture (CORBA) Facilitates technical interoperability among disparate information systems Recognized as a potential solution in healthcare informatics Has not been operationalized in clinical research context FIRST Technologies  Software architecture based on international standards & interoperable components   Leveraging existing standards or help expand/ build new ones Systems are “future proof” if retain CORBA-compliant interfaces OpenEMed (formerly TeleMed)  An intuitive patient-record system that supports, image, audio, and graphical data – – Open-source, interoperable components based on OMG Healthcare Domain Taskforce interface standards Enables multiple databases to be integrated together to create a virtual patient record    Individual healthcare facilities still own and manage their own data Data accessible to others who have treated the same patient Security of the data is maintained, patient privacy and confidentiality is ensured OpenEMed (formerly TeleMed)  CORBA “Services” used in FIRST  PIDS:  Person Identification Service Correlate health records among multiple institution based on a "core" set of profile elements, while protecting confidentiality  COAS: Clinical Observation Access Service  Interface to supply clinical observations, including raw data recordings, and derived judgments or knowledge Applying OpenEMed to FIRST Global Model Protocol Status: Registration PIDS COAS Conditions met, N slots available N–1 Slots Available Reported SAE First Study Participant Status: PIDS Eligibility Filtering COAS Eligibility Screening Consenting Processes Accessioning Processes Treatment SAE ... Data Collection Process: Eligibility Checklist COAS Consent Form Form A Form B Form C SAE Form Significance of FIRST Technologies  Technology behind FIRST application prototypes much more significant than their applied functionality   Significant advantages through flexibility and re-usability of CORBA services Minimizes additional development later (e.g. security and auditing capability)  Places emphasis on knowledge representation, rather than database construction Defines relationships among data elements Graphical Representation of PIDS XML configuration files (505)672-1200 111-222-3333 Tells service what the data is Data •patient PIDS (service) Can be HL-7, flat files, etc PIDS DB Entity-Attribute-Value (EAV) structural independence Stores data & preserves relationships defined by the configuration file, maintained by PIDS service Protocol Abstraction Underlies All FIRST Applications  Abstraction Categories:            Administrative Overview Study Personnel Protocol Entities / Organizations Study Design Scientific Objectives Eligibility Criteria Statistical Approach Treatment Roadmap Toxicity Monitoring Outcomes Assessment Data Collection Expectation  Obvious logical extension: protocol authoring via FIRST Sample FIRST Application Example Screen # 22 Protocol Abstraction - Eligibility Filtering Criteria pg 1 Protocol Participant Reports Other Exit Overview InformationMain Menu Fully Integrated Related Entities, Committees & Organizations Protocol Registration Research Protocol Personnel Protocol Abstraction Standards & Scientific Abstraction Protocol Management Tasks Technology Eligibility Criteria Statistical Approach Eligibility Filtering Criteria Oncologic Studies Demographics Gender: Female Age:* 3 Minimum months 18 Maximum years *note: If physiologic age is used, enter the upper limit +5 years for the maximum Status Check all eligible functional status descriptions: Able to carry on normal activity and to work; no special care needed Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly X X Minimum life expectancy: 3 months And above Click here to communicate with the System Administrator Example Screen # 27 - Edit/View Protocol Abstraction - Participant Characteristics for Eligibility Filtering - Disease List Protocol Participant Reports Other Main Menu Fully Overview Information Integrated Protocol Registration Committees & Organizations Research Protocol Abstraction Protocol Personnel Standards & Protocol Management Tasks Scientific Abstraction Technology Eligibility Criteria FIRSTSM Unique Protocol ID: Prefill from search Statistical Approach NCI Disease List: Check all eligible Solid Tumors: Anus Any Solid Any Hem Prostate Rectum Respiratory & intrathoracic Organs, other Exit This protocol is ‘available’ for accrual Any Diagnosis Hematologic: Hematopoietic, other Leukemia, Lymphoid Leukemia, Monocytic Leukemia, Myeloid Leukemia, not otherwise specified X Esophagus Eye and Orbit Genital - Female, other Genital - Male, other Bones & Joint Brain & Nervous System Skin Melanoma Skin, other Small Intestine Soft Tissue Stomach Thyroid Unknown Sites Urinary Bladder Urinary, other Breast - Female Breast - Male Buccal Cavity & Pharynx Ill-defined Sites Kaposis Sarcoma Kidney Larynx Liver Lung Ovary Lymphoma, Hodgkin‟s Lymphoma, Non-Hodgkin's Cervix Colon Corpus Digestive Organ, other Endocrine System, other Mycosis Fungoides Multiple Myeloma Pancreas Click here to communicate with the System Administrator Clear OK Example Screen # 50 - Protocol Filtering Search Results Protocol Fully Integrated Research Standards & Technology Participant Reports Other Main Menu Exit Protocol Matches for : Name: Kelly M Clarkson FIRSTSM Unique Person ID: 46586 Pt ID:(Prefill pt ID #) Protocol Information F 20 No Assist Lymphoma Yes Yes 6 mo #113 #540 #700 #003 N/A N/A N/A N/A to 18yrs 18yrs to 70yrs 18yrs to 65yrs 18yrs to No Assist; Some Assist No Assist; Some Assist No Assist; Some Assist No Assist; Some Assist Lymphoma All Hem All Hem Any Cancer Yes N/A N/A N/A Yes N/A N/A N/A 3 mo 3 mo N/A N/A N/A N/A N/A N/A Filter Summary: 15 protocols in FIRST;10 available for searching; 5 matched your query Click here to communicate with the System Administrator Protocol Abstraction for Eligibility Matching Patient Eligibility Criteria Protocol Filtering Rules Test Scenarios Fixed Parameters Used for testing filtering rules: Unique Protocol ID 34, Patient First ID: 35 Test Scenario Protocol filtering characterizes: Gender Set protocol gender demographics to 1 undifferentiated, patient gender to undifferentiated Set protocol gender demographics to 2 undifferentiated, patient gender to female Expected Result Actual Result Protocol is displayed in the result grid Protocol is displayed in the result grid Protocol is displayed in the result grid Protocol is displayed in the result grid Pass / Failed Date of Test 3 4 5 6 7 8 9 Since protocol is set to undifferentiated, this protocol should display Since protocol is set to undifferentiated, this protocol should display Set protocol gender demographics to Since protocol is set to undifferentiated, patient gender to male undifferentiated, this protocol should display Set protocol gender demographics to female, Since protocol is set to patient gender to undifferentiated undifferentiated, this protocol should display Set protocol gender demographics to female, This protocol should display patient gender set to female Set protocol gender demographics to female, This protocol should not patient gender set to male display Set protocol gender demographics to male, patient gender set to undifferentiated Set protocol gender demographics to male, patient gender set to female Set protocol gender demographics to male, patient gender set to male Pass 1/29/04 Pass 1/29/04 Pass 1/29/04 Pass Pass Pass Pass Pass Pass 1/29/04 1/29/04 1/29/04 1/29/04 1/29/04 1/29/04 Protocol is displayed in the result grid Procotol is not displayed in the result grid This protocol should display Protocol is displayed in the result grid This protocol should not Protocol is not display displayed in the result grid This protocol should display Protocol is displayed in the result grid Actual Result Protocol is displayed in result grid Protocol is displayed in result grid Test Scenario Expected Result Protocol filtering characterizes: Min Age, Max Age Set min age to empty(year), max age to This protocol should display 10 empty(year), set patient DOB to any date Set min age to empty(month), max age to This protocol should display 11 empty(month), set patient DOB to any date Pass / Failed Date of Test Pass Pass 1/29/04 1/29/04 12 Set min age to 18(year), max age to empty(year), set patient DOB to 8/14/1976 Set min age to 18(month), max age to empty(year), set patient DOB to 8/14/1976 Set min age to 30(year), max age to empty (year), set patient DOB to 8/14/1976 Set min age to 30(month), max age to empty(year), set patient DOB to 8/14/1976 Set min age to empty(year), max age to 18(year), set patient DOB to 8/14/1976 Set min age to empty(year), max age to 18(month), set patient DOB to 8/14/1976 Set min age to 0(year), max age to 18(year), set patient DOB to 8/14/1976 Set min age to 0(month), max age to 18(month), set patient DOB to 8/14/1976 Set min age to 30(year), max age to 60(year), set patient DOB to 8/14/1976 Set min age to 30(month), max age to 60(month), set patient DOB to 8/14/1976 Set min age to 18(year), max age to 30(month), set patient DOB to 8/14/1976 Set min age to 'asdf'(year), max age to empty(year), set patient DOB to 8/14/1976 Set min age to empty(year), max age to 'asdf'(year), set patient DOB to 8/14/1976 13 14 15 16 17 18 19 20 21 22 23 24 Since patient DOB is over 18 years, this protocol should display Since patient DOB is over 18 months, this protocol should display Since patient DOB is under 30 years, this protocol should not display Since patient DOB is over 30 months, this protocol should display Since patient DOB is over 18 years, this protocol should not display Since patient DOB is over 18 months, this protocol should not display Since patient DOB is over 18 years, this protocol should not display Since patient DOB is over 18 months, this protocol should not display Since patient DOB is under 30 years, this protocol should not display Since patient DOB is over 60 months, this protocol should not display ? System should not take character values System should not take character values Protocol is displayed in result grid Protocol is displayed in result grid Protocol is displayed in result grid Protocol is displayed in result grid Protocol is displayed in result grid Protocol is displayed in result grid Protocol is not displayed in result grid Protocol is not displayed in result grid Protocol is not displayed in result grid Protocol is not displayed in result grid Protocol is not displayed in result grid 500 Servlet Exception Error 500 Servlet Exception Error Pass 1/29/04 Pass 1/29/04 Failed 1/29/04 Pass 1/29/04 Failed 1/29/04 Failed 1/29/04 Pass 1/29/04 Pass 1/29/04 Pass 1/29/04 Pass ? Failed Failed 1/29/04 1/29/04 2/6/04 2/6/04 Possible caBIG Development Approach: Year One Proposed Approach to caBIG Module A User Specifications Knowledge Representation Application Development Testing and Deployment UML Use Cases HL7 RIM XML / PIDS / COAS/ Web Test Specifications User Manuals Possible Iterative Approach to caBIG Development NCI Working Group Specifies & prioritizes desired functionality Univ of Pitt Deploys their current module Adopters Utilizes module City of Hope UML Use Cases Review and Comment HL7 RIM caBIG Application Development caGIB Application Development Review and Comment Review and Comment Create Test Specifications Review and comment Create Test Specifications Deploy for Testing Review and Comment Testing Deploy for Testing Review and comment Review and Comment Review and Comment Build User Documentation Discussion FIRST System Design  3-tier architecture Presentation Layer Java-based Middle Tier XML Process Definition Language Rules Engine Data Layer CORBA / OpenEMed

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