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CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs November 2020

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

For new animal drug applications, FDA requires full reports of investigations which have been conducted to show a drug is safe and effective for use [section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)]. Additionally, section 512(n)(1)(E) of the FD&C Act requires that abbreviated applications for the approval of a new animal drug contain information to show that the new animal drug is bioequivalent to the approved new animal drug.

Submissions to CVM in support of new animal drug applications generally include a Final Study Report (FSR) for one or more studies. For each study that includes electronic data files, CVM needs information regarding documentation of the process for data generation and the statistical analysis conducted in order to review submissions and verify that there is sufficient quality and detail of evidence to support an animal drug application. An adequately documented submission should include readable electronic data files, a description of how the data are processed, and a description of the statistical analyses employed to support your conclusions.

Your documentation should clearly describe the entire process by which the data were collected, including a record of all changes to the data, starting from the electronic data files created from transcribed case report forms, or from electronic data capture systems, to the completed statistical analyses which form the basis for your study’s conclusions. To understand the process by which you compiled the data and conducted the statistical analysis, CVM needs to understand the contents of each data file, the computer programs that processed all the electronic data files for analysis, and the programs that implemented the statistical analyses. The information that should be submitted to CVM, together with the FSR and electronic datasets, are described in this guidance, along with recommendations for how README files should be organized and completed to describe the datasets and analysis, and additional recommendations regarding statistical programs.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0052.


Contact Point
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
(240) 402-7002
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