1. Second Annual Japan CDISC Group (JCG) Meeting 28 January 2004 Julie Evans Director, Technical Services

2. CDISC Team Updates

3. SDS Team Update 2003 Progress (1) Release new V3 models as an HL7 document –Completed for V3.0 in June 2003; V3.1 planned for 5/04 Support FDA initiatives for standard tools with a pilot test of V3 models –Complete; an FDA public meeting reporting the results held on 10/2/03.

4. SDS Team Update 2003 Progress (2) Expand models with controlled terminology –A sub-team was created and produced a plan and draft document on initial controlled terminology standards; however, release has been delayed at request of FDA pending a SNOMED impact assessment; V. 3 and V.3.1 identify variables that will be subject to controlled terminology. Define new domains for commonly used data –3 new domains included in V3; 3-6 more ready to be included in V3.1. Support implementation in industry with additional documentation and support materials –Additional V3 documentation published in June and August 2003. Work in progress on implementation guide and change summary.

5. SDS Team Update 2003 Progress (3) Establish an ongoing standards maintenance process –Responsibility has been transferred to Julie Evans; maintenance currently managed by SDS team. Develop and adopt conformity policy and guidelines for the SDS –Complete – included in V3 Specification Assist in educational tutorials. –Ongoing. SDS training now performed by team member Jane Boone; other SDS volunteers include Fred Wood and Mike Walega.

6. SDS Team Update 2004 Goals Finalize Version 3.1 and support issuance of FDA Guidance Maintain model (1 maintenance release) Complete critical controlled terminology Provide additional domain models Provide additional training and implementation guides Provide support and maintenance function.

7. ODM Team Update 2003 Progress (1) Develop a minor release (V1.2) to address issues and enhancement requests from early adopters. –Draft was published in July; Final was posted early this month. Develop Schema version in conjunction with new minor release. –V1.2 includes a schema Develop a use case to support the use of the ODM for transferring SDS Metadata to the FDA. –Define.xml was developed and is being balloted as HL7 an informative document

8. ODM Team Update 2003 Progress (2) Continue to work with the Lab Team to develop a harmonized XML model. –Changes were made in Lab model to align with ODM Develop Archive, Lab Use, Metadata, EDC/M and other use case documents for publication, one per quarter. –Metadata Use Case is posted on website; Archive is in development Form a European sub-team in Q2 –Team has been formed and is very active

9. ODM Team Update 2004 Goals Develop the case for use of ODM for eSubmissions Harmonize with the SDS, ADaM and Lab models Harmonize with HL7 Develop an ODM Implementation Guide Produce maintenance release(s) Develop new ODM features as needed to support Regulatory Use and CDISC model harmonization

10. LAB Team Update 2003 Progress (1) Submit HL7 version of LAB model to ballot –CDISC LAB model approved as an HL 7 Version 3 message Post draft XML schema, revise with comments received and finalize – Developed XML implementation of the LAB model Post draft microbiology extension for review –Developed extensions for both Microbiology and ECG

11. LAB Team Update 2003 Progress (2) Harmonize with ODM model with mapping of LAB to ODM –Developed V1.0.1, which addressed issues of harmonization with other CDISC models Monitor and respond to feedback on LAB model Version 1.0 –Ongoing: published V1.0.1 to address feedback Collect, analyze, and publish metrics on model implementation –Published Case Study template

12. LAB Team Update 2003 Progress (3) Make presentations at industry meetings –Presented at Pharmaceutical SAS Users Group and IBM Seminars Hold Netmeeting(s) for LAB users group –Held LAB Roundtable at Interchange Finalize clinical trial laboratory test dataset for subsetting RELMA –Developed CDISC subset and submitted to LOINC Develop high level draft of pharmacogenomics extension –Began work on genomics extension and specimen handling extensions

13. LAB Team Update 2003 Progress (4) Develop and adopt conformity policy and guidelines for the Lab model –Developed draft conformity levels and profiles Assist in educational tutorials –Developed training workshop –Worked with training consultant on online training Additional accomplishments: –Worked with central laboratories to encourage sponsors to use LAB model. Some central labs now offering a discount to clients that are willing to use the CDISC LAB model as a data interchange format.

14. LAB Team Update 2004 Goals (1) Finalize Version 1-0-1 of LAB Model, including XML implementation, Microbiology extension Post ECG extension for public comment, then finalize Further develop specimen handling and genomics extensions and post for public comment

15. LAB Team Update 2004 Goals (2) Continue to work to encourage awareness and adaptation of the LAB model by pharma and biotech companies Finish development of the online training program for the LAB model

16. ADaM Team Update 2003 Progress (1) Complete and post 3 statistical models with input from FDA statisticians. –Completed three statistical analysis models: Change from Baseline, Time to Event (Survival Analysis) and Categorical Analysis. Identify 2 additional analysis submission models for development. –Drafts of Linear Models Analysis, Safety Analysis position paper Continue collaboration with FDA on Safety Analysis –Presented Safety Analysis position paper at FDA

17. ADaM Team Update 2003 Progress (2) Develop and adopt conformity policy and guidelines for analysis submission datasets. –Tied to conformity for SDS V3.1 Develop and post position paper on imputation and data flags. Incorporate the concept in at least one data model. –Collaborated with SDS and developed ADaM standards for SAS date variable and imputation flags Develop and post position paper on documentation of the creation of analysis files. –Drafted plan for describing and standardizing creation of analysis datasets

18. ADaM Team Update 2003 Progress (3) Collaborate with SDS on the development of version-3 domain data models. –Provided feedback to SDS regarding V3. Assist in educational tutorials. –Provided input for training materials

19. ADaM Team Update 2004 Goals (1) Develop a model for analysis metadata. Provide input on upcoming FDA Guidance on Submission of Analysis Datasets. Develop a library of “real world” examples of issues and decisions that arise in the creation of analysis datasets from the source variables. Revise existing statistical models to conform to SDS V3.1 nomenclature and ICH E3 eCTD Draft Guidance. Complete Linear Models Analysis statistical model.

20. ADaM Team Update 2004 Goals (2) Identify and develop 2 additional analysis submission models. Continue collaboration with FDA on Safety Analysis Continue participation in the DEFINE.XML project. Collaborate with and participate in the development of the structured analysis plan with the Protocol Representation Group. Assist in educational tutorials relating to Analysis Datasets.