On February 16, 2018, FDA issued draft guidance describing the standardized format for electronic submission of data and information for all major (i.e., pivotal) studies used to support safety and efficacy claims in NDAs, BLAs regulated by CDER, and INDs in advance of a planned NDA, BLA, or supplemental submission. The guidance is part of FDA’s ongoing effort to standardize formatting for Bioresearch Monitoring (BIMO) inspection submissions to CDER.

To facilitate BIMO inspection planning, site selection and the conduct of inspections, FDA requests that applicants provide: (1) a comprehensive and readily located table listing all clinical sites that participated in clinical studies; (2) a table listing all entities whom the sponsor has contracted clinical study-related activities; and (3) protocols, protocol amendments, and annotated case report forms.

To allow verification of key study data during inspections, FDA requests that applicants provide subject-level data line listings by clinical site, including studies with different treatment indications. In addition, applicants should submit summary-level clinical site datasets containing data from pivotal studies to support safety and efficacy claims, including independent data for each study in cases where clinical investigator sites are involved in multiple studies.

Specifications for the electronic format and additional information on submitting the clinical study-level information, the subject-level data line listings by clinical site, and the summary-level clinical dataset is provided in the Bioresearch Monitoring Technical Conformance Guide.

Readers are encouraged to read the draft guidance, also available on FDA’s website. Comments and suggestions regarding the draft guidance should be submitted to FDA by April 17, 2018.