New - Updated Version of Pilot Submission Package (2013) Now Available
The ADaM and SDS teams are pleased to announce the release of an update to the first CDISC SDTM/ADaM Pilot Project. The original pilot project submission package was finalized and released in February, 2007 following a review by FDA Staff who evaluated the CDISC data and metadata contained within the package for its suitability in meeting the needs and expectations of medical and statistical reviewers. The package was provided as a mock submission that included one "pivotal" study. In the years since the package was posted, many of the standards have changed or have been updated, including the notable release of the first ADaM implementation guide. The new package contains updates to the SDTMIG and ADaM data and the define.xml metadata. Details of these updates can be found in the cover letter included in the zip file.
By providing an example of how more current standards can be applied, the Pilot Project Update team hopes that this package will encourage broader and more consistent use of CDISC standards across the industry.
SDTM/ADaM Pilot Project Background
The CDISC SDTM / ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. (This pilot project is also referred to as “Pilot 1.” It was conducted during 2006 and 2007) The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated metadata met the needs and the expectations of both medical and statistical FDA reviewers. In doing this, the project also assessed the data structure, resources and processes needed to transform source data into the SDTM and ADaM formats and to create the associated metadata.
This pilot project effort represented an unprecedented amount of work and collaboration between CDISC, the Industry and FDA and led to a number of valuable learnings, documented in the project report. However, it must be noted that all comments, statements, and opinions attributed in the project report to the regulatory (FDA) review team reflect views of those individuals conveyed as informal feedback to the pilot project team, and must not be taken to represent guidance, policy, or evaluation from the Food and Drug Administration
All of the aforementioned goals were met by the CDISC SDTM/ADaM Pilot Project. The project established that the package submitted using CDISC standards met the needs and the expectations of both medical and statistical reviewers participating on the regulatory review team. The regulatory review team noted the importance of having both data in SDTM format to support the use of FDA review systems and interactive review, and data in ADaM format to support analytic review. The project also demonstrated the importance of having documentation of the data (e.g., the metadata provided in the data definition file) that provides clear, unambiguous communication of the science and statistics of the trial.
The regulatory review team expressed a favorable impression of the pilot submission package. They were optimistic about the impact that data standards will have on the work associated with their review of new drug applications.