21 CFR § 312.87 - Active monitoring of conduct and evaluation of clinical trials.

---
identifier: "/us/cfr/t21/s312.87"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.87 - Active monitoring of conduct and evaluation of clinical trials."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.87"
section_name: "Active monitoring of conduct and evaluation of clinical trials."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 312.87 Active monitoring of conduct and evaluation of clinical trials.

For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be involved in facilitating their appropriate progress.