Clinical Data Standards Governance. Tammy Burns, Expert Clinical Data Manager 11 th January 2013

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1 Clinical Data Standards Governance Tammy Burns, Expert Clinical Data Manager 11 th January 2013

2 Standards Used and Formal Govenance Standard Types General and Therapeutic Area Data Standards Collection Modules EMD Serono/Merck Serono SDTM Standards EMD Serono/Merck Serono ADaM Standards Controlled Terminology Value Level Metadata GBS Output Standards Standard algorithms The official CDISC Standards Standard validated programs and tools Standard mappings 2 Clinical Data Standards Governance

3 Objective of the WI To describe the management of the general and therapeutic area data standards, Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) in relation to the creation, use, maintenance and documentation of the standards, to ensure data consistency and to facilitate regulatory submissions 3 Clinical Data Standards Governance

4 Standards Governance Requires empowerment of governance teams to reinforce the standards within the organisation and a strong support from upper management It requires the governance teams to be advocates for the use of standards increasing the acceptance across the organisation Allocating resources for standards management is a must to achieve the benefits 4 Clinical Data Standards Governance

5 Governance Teams Standards Governance Teams General Data Standards (DS) Team Therapeutic Area Data Standards (TA DS) Team for each of the main Therapeutic Areas Membership DS Team Lead Clinical Data Standards Librarian(s) Controlled Terminology Librarian TA DS Team Lead Controlled Terminology Librarian Merck Serono (MS) SDTM Team Merck Serono (MS) ADaM Team SDTM Team Lead (appointed by the Head of Global Clinical Data Science or designee) SDTM Librarian(s) Controlled Terminology Librarian MS ADaM Team Representative appointed by the MS ADaM Team Lead MS ADaM Team Lead (appointed by the Head of Global Biostatistics or designee) Statistical Standards Librarian (ADaM) Statistical Programmer(s) Biostatistician(s) 5 Presentation title in footer 00 Month 0000

6 Standards Governance Teams (ctd) Organisation Level Function EMD Serono/Merck Serono Clinical Governance Head of GDM and GBS Standard Type General Data Standards Team TA Data Standards Team SDTM Team ADaM Team Project PDM PDM Specialist / PDM Specialist /Project Stats Prog / Biostat Trial TDM CRO TDM CRO TDM CRO Trial Stats Prog Trial Biostat CRO 6 Clinical Data Standards Governance

7 When is the governance process used? Previous governance only required an exemption when not complying with the existing standard. Study specific forms did not require approval/governance process. The new governance requires if the current clinical data standards do not cover all the requirements for setting up any of the trial specifications (e.g. ecrf, SDTM, ADaM) or anything which does not comply with an existing standard a New, Change or Exemption Request Form is completed and approved prior to implementation. 7 Clinical Data Standards Governance

8 Completion of Metadata on the Clinical Data Standards New, Change or Exemption Request Form When the governance was updated to incorporate the governance of SDTM, CT and ADaM Standards it was felt that the SDTM metadata should be provided as early as when the CRFs were being designed We then agreed to take a flexible approach to the completion of the New, Change or Exemption form so that the process can be adapted to what is required and what is feasible. Definition of all metadata is now not required at the CRF creation phase. However, where possible, the minimum information should be collected (i.e. CT and VLM) and an SDTM Expert should review the request to evaluate the impact on the SDTM 8 Clinical Data Standards Governance

9 When, How Much and Where Do We Govern How do we balance strict timelines for go-live of a CRF with time to manage and mandate the use of standards? Do we govern the SDTM at the same time as the General Clinical Data Collection Standards? Do we govern all forms and modules including study specific? 9 Clinical Data Standards Governance

10 Standards and Governance Team Objectives Development of new standards Assessing the impact of new releases of CDISC standards and related guidance from Health Authorities on the company specific standards Freezing standards which are no longer in use Providing general rules and conventions for company specific use of general data standards, control terminology, CDISC SDTM and ADaM, as applicable Develop and provide training 10 Clinical Data Standards Governance

11 Standards and Governance Team Objectives Providing expert guidance on the application of the standards Compliance to existing standards Management of exemptions Track all exemptions and review them for potential changes to the standards Track and review all requests for updates to the standards and make the changes or provide rationale as to why a request is not made 11 Clinical Data Standards Governance