FDA Invites Comments on Clinical Data Template

The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials.

The analysis data reviewer's guide template was developed by the Pharmaceutical Users Software Exchange (PhUSE), an independent, nonprofit consortium that includes the FDA and other regulatory agencies, as well as academic, nonprofit and private-sector representatives.

The agency will review the proposed template and comments and determine whether to recommend its use in its current or a modified form in accordance with the FDA Study Technical Conformance Guide.