The SDTM Annotated Case Report Form (CRF) is a document that provides a mapping between the data collected in a clinical trial and the variables in the Study Data Tabulation Model (SDTM) standard. The SDTM Annotated CRF is typically created during the data management and analysis phase of a clinical trial and is used to guide the conversion of raw clinical trial data into SDTM datasets that can be submitted to regulatory authorities.
The SDTM Annotated CRF includes a copy of the original CRF used in the clinical trial, with each data field annotated to indicate the corresponding SDTM variable name, format, and other metadata. The annotations may also include information about any derivations or transformations that are needed to map the data to the SDTM format.
The SDTM Annotated CRF serves as a key document in the SDTM conversion process, providing a clear and detailed description of how the data collected in the trial should be mapped to the SDTM standard. It also facilitates the review and validation of SDTM datasets by regulatory authorities, as it provides a clear audit trail linking the raw clinical trial data to the final SDTM datasets.
Overall, the SDTM Annotated CRF is an important tool in ensuring that clinical trial data is accurately and consistently converted to the SDTM format, which is a key requirement for regulatory submission and analysis.