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GUIDANCE DOCUMENT

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE February 2018

Draft

Not for implementation. Contains non-binding recommendations.

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document provides current Food and Drug Administration (FDA) specifications for preparing and submitting Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and a Summary-Level Clinical Site Dataset that are used by the Center for Drug Evaluation and Research (CDER) for planning of Bioresearch Monitoring (BIMO) inspections in electronic form for new drug applications (NDAs), biologics license applications (BLAs), and NDA or BLA supplemental applications containing clinical data that are regulated by CDER. It also applies when these data and information are submitted under certain investigational new drug applications (INDs) in advance of a planned NDA, BLA, or supplemental submission.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.