FDA regulatory requirements call for submission of study data in electronic format. This requirement is true even if the marketing application is in paper format. Study data includes information from trials submitted to the agency for evaluation and information to understand the data. The study data typically include the following:

• SAS Transport files
• Data Definitions file
• Annotated CRF

Regulations in 21 CFR Part 11 require all datasets submitted in electronic format to provide an accurate and complete copy of the data suitable for inspection, review, and copying. Currently, the FDA require all clinical data submitted in SAS System XPORT transport format (Version 5 SAS transport file) for review and archiving.

The data definition file describes the format and content of the submitted datasets. In order to increase the level of automation and improve the efficiency of the Regulatory Review process the FDA announced specifications for dataset data definitions using CDISC SDTM standards and these are incorporated in the Case Report Tabulation Data Definition Specification (define.xml) developed by the CDISC define.xml Team.

Annotated CRF is a blank case report form with annotations that document the location of the data with the corresponding names of the datasets and the names of those variables included in the submitted datasets.

Our Solution

DefinePDF^® is a one-step solution to automatically create the entire CRT section of an electronic submission.

ezFormUtil™ is a Acrobat plug-in to automate the CRF annotation process.