CDISC Data Standards Validation

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1 CDISC Data Standards Validation How can it be done? Peter Van Reusel Business Unit Director Business & Decision Life Sciences Tel Fax Mobile peter.vanreusel@businessdecision.com Sint-Lambertusstraat 141 Rue Saint- Lambert 1200 Brussels

2 Topics 1 Current Situation 2 Applied CDISC Compliance 3 Summary

3 Topics 1 Current Situation 2 Applied CDISC Compliance 3 Summary

4 FDA Submissions (1) It is requested to submit clinical trial data (SDTM) & metadata (Define.xml) according to the SDTMIG V3.1.2 standards It is highly recommended to submit analysis data (ADaM) and metadata (Define.xml) according to the ADaMIG V1.0 standards Data standards allow the FDA to use standard tools

5 FDA Submissions (2) Applies to both FDA CBER and FDA CDER (Study Data Specifications) nrequirements/electronicsubmissions/ucm pdf CBER has recently released new documentation for submitting data to CBER (Submision of data in CDISC format to CBER) Office of Vaccines Research and Review May 15, 2010 Office of Blood Research and Review September 1, 2010 Office of Cellular and Gene Therapies December htm CDER has prepared a Data Standards Plan which will be released to the public soon nrequirements/electronicsubmissions/ucm pdf

6 SDTM FDA Tools: Patient Profile Viewer

7 SDTM FDA Tools: JReview (1)

8 SDTM FDA Tools: JReview (2) v3.1 Training Materials

9 SDTM FDA Tools: WebSDM (1) v3.1 Training Materials

10 SDTM FDA Tools: WebSDM (2)

11 SDTM FDA Tools: WebSDM (3)

12 CDISC Data Model Conformance (SDTM & ADaM) Follow complete metadata structure Follow CDISC domain models Include all Required and Expected variables Use CDISC-specified: standard domain names and prefixes standard variable names variable labels (SDTM only) data types for all variables (SDTM only) controlled terminology and format guidelines Currently, adhere to the SAS V5 XPT limitations Ensure that each dataset includes a set of keys Ensure that each record in a dataset includes a topic variable (SDTM only) Conform to all business rules

13 Results of non-compliance Not following data standards will: break the tools create confusion and frustration give the impression that the sponsor does not control the data

14 Current status (1) Validation check history WebSDM (1.5, 2.6, 3.0), SDTMIG (3.1, 3.1.1, 3.1.2), ADaMIG (1.0) Today, different vendors have developed a specific tool WebSDM Data Model Compliance Checker Validator Checkpoint Clinical Standards Toolkit

15 Current status (2) Different vendors have created different checks Different tools are producing different output Rules and checks are not clearly defined There is no official version yet

16 Current status (3) ADaM team: Has published ADaMIG V1.0 ( Dec. 17, 2009) Has developed a draft check list (June 11, 2010) Is preparing a final version SDTM team did not create a check list CDISC has started the CAB VP CDISC Advisory Board Validation Project To create one official version of the SDTM checks Broad industry representation Representing all of the 5 major vendors and the FDA

17 Current status (4) Ongoing comparison and consolidation between all checks Unambiguous check specification will avoid check interpretation

18 FDA CRT Submission Process (1) Data Tabulation Components: SDTM annotated CRFs SDTM datasets ADaM datasets Define.xml metadata

19 FDA CRT Submission Process (2) WebSDM and OpenCDISC tools check the CDISC SDTM data & metadata to ensure standard FDA tools can be used

20 FDA CRT Submission Process (3) CDISC SDTM (& ADaM) compliance issues are reported to the sponsor

21 Janus layers Source: «CDISC Standards, Present & Future», Dave Iberson-Hurst, CDISC, VP Technical Strategy

22 SDTM Compliance Issues Report OBPS provides an SDTM issue list to the sponsor OBPS = Office of Business Process Support Loading issues can be caused by Data & Metadata Inconsistency Non conformity with:» SDTM Model» SDTM IG business rules» Controlled Terminology

23 Topics 1 Current Situation 2 Applied CDISC Compliance 3 Summary

24 CDISC Compliance Checks We have created an expanded & enhanced list of checks 154 WebSDM checks Total check package: SDTMIG V3.1.1 SDTMIG V3.1.2 ADaMIG V1.0 Data checks Metadata checks Mapping checks Project consistency checks CDISC compliance checks list is growing continuously

25 Categorization CDISC Compliance Checks Categories Data Metadata Class Domain Mapping Timing variables Data model version Check version

26 Application Flowchart Metadata definition of the data model or sponsor proprietary data standards + CDISC controlled terminology

27 Application Flowchart The data model compliance checks system reads the folder with the SDTM, ADaM datasets & the define.xml metadata file

28 Application Flowchart DEFINE.XML SDTM DATASETS ADaM DATASETS DATA & METADATA ENVIRONMENT METADATA DATABASE CHECK SCHEDULER EXCEPTION TABLE SDTMIG V3.1.1 SDTMIG V3.1.2 ADaMIG V1.0 METADATA LIBRARY Metadata Cross Checks DEFINED JOB CHECK SELECTION SDTM COMPLIANCE ISSUE REPORT Data Model Compliance Checks cross-check for consistency between: CDISC SDTM or ADaM datasets definition Metadata reported in the Define.xml CDISC SDTM, ADaM or sponsor proprietary data standards in the metadata library

29 Application Flowchart A job definition is created in the application interface

30 Application Flowchart Identified quality issues are added to an exception table Quality check reports are generated for further processing

31 Application Interface

32 Application Interface Data Model Selection Screen Select Data Model Possibility to add proprietary data models Select Controlled Terminology CDISC Controlled Terminology Possibility to include sponsor-defined controlled terminology

33 Application Interface

34 Application Interface Job Creation Screen Check Selection : Select Project and Study Select Checks based on Class Events, Interventions, Findings, Trial Design, Special Purpose, Findings About Type Data, Metadata, Programming Individual Select from dynamically created list of domains Creates Job ID Check Description : Detailed description of all checks Possibility of adding/modifying check descriptions

35 Application Interface Check Selection :

36 Application Interface Check Description:

37 Application Interface Run Job Screen Job List :» Lists Job ID, Job description, Job owner, Job creation date» Select the job to run Job Description :» Lists project and studyid for the selected job» Lists checks to run for the selected job» Lists domains on which selected checks run

38 Application Interface Job List

39 Application Interface Job Description

40 Application Interface Parameter Database Central table for project and study parameters

41 Reporting Tool (1) 3 reports are created: Exception log Exception summary Exception report > 50 exceptions per check per domain: only 3 exceptions are reported

42 Reporting Tool (2) 3 reports are created: Exception log Exception summary Exception report > 50 exceptions per check per domain: only 3 exceptions are reported

43 Reporting Tool (3) 3 reports are created: Exception log Exception summary Exception report > 50 exceptions per check per domain: only 3 exceptions are reported Reported Exception Record Identifiers Exception Attributes

44 Topics 1 Current Situation 2 Applied CDISC Compliance 3 Summary

45 Summary CDISC compliance will facilitate: The use of the FDA tools In-house communication between CRO and sponsors Running these checks do not necessarily solve all findings but sponsor is prepared for FDA feedback Document confirmed issues in FDA Reviewers Guide CBER calls this the Validation and Data Interpretation Report FDA will not reject your submission (yet)!

47 Thank you for your attention Peter Van Reusel Business Unit Director Business & Decision Life Sciences Tel Fax Mobile peter.vanreusel@businessdecision.com Sint-Lambertusstraat 141 Rue Saint- Lambert 1200 Brussels

The Evolution of SDTM

The Evolution of SDTM What s new? Tina Apers CRO Manager Mobile +32 476 60 08 79 tina.apers@businessdecision.com Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Sint-Lambertusstraat