15/16 September 2020
The U.S. Food and Drug Administration (FDA) published a draft guidance on Documenting Electronic Data Files and Statistical Analysis Programs for comment. The guidance has been provided to inform sponsors of recommendations for submissions to the Center for Veterinary Medicine (CVM) to support new animal drug applications. The aim of the guidance is to reduce the number of revisions that may be required for CVM to effectively review data submissions. Additionally, submission preparation for sponsors is clarified by providing a suggested framework, including examples, on how to describe and organize the information regarding the electronic data files and statistical analysis programs.
The revised version of the draft guidance replaces the version made available in December 2015. FDA says, "the document has been revised to update contact information, clarify existing language, remove recommendations that are no longer applicable, and provide additional details on the README file". Comments on this draft guidance should be submitted by July 20, 2018.
Submissions to support new animal drug applications generally include a Final Study Report (FSR). For each study that includes electronic data files, CVM needs additional information regarding documentation of the process for data generation and the statistical analysis conducted. Therefore, the submission should include
The documentation should clearly describe the entire process by which the data were collected, including the computer programs that processed all electronic data files for analysis, and the programs that implemented the statistical analyses. The draft guidance describes the information which should be submitted, together with the FSR and electronic datasets, and gives recommendations for how README files should be organized and completed.
The README file (typically a PDF file with the filename README.pdf) is an overview of electronic data files (e.g. Case Report Forms - CRFs), documentation, and programming files included in the submission. An effective README file should quickly orient the assessor to crucial information needed to understand the electronic files.The README Files should include a brief introduction, background and other information relevant to analyzing and interpreting the data. A data flow could also be provided, such as audit trail processes or how the data were captured and merged to derive the analysis datasets. According to FDA, it is acceptable to submit a separate document (e.g., a Statistical Report) as an appendix in the FSR that provides details on the statistical analysis (then the information does not have to be repeated in the README file).
Furthermore, the draft guidance contains an APPENDIX providing examples of SAS codes that convert data files to acceptable formats (i.e. non-proprietary XML files, XPT files). Finally, the document shows detailed examples for the following topics:
Electronic Data Files (e.g. Data Collection Forms) should be provided as
Audit Trail Files
For Data Analysis Programs the following should be included: