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# Info Collection Extension for Clinical Trial Monitoring
- URL: https://www.fdaweb.com/info-collection-extension-for-clinical-trial-monitoring/
- Published: 2018-12-03T12:00:00.000Z
- Updated: 2026-09-15T00:48:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142937

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled: “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring — 21 CFR Parts 312 and 812” (OMB Control Number 0910-0733). The information collection supports reporting and recordkeeping found in agency guidance. Under 21 CFR parts 312 and 812, sponsors are required to provide appropriate oversight of their clinical investigations to ensure adequate protection of the rights, welfare, and safety of human subjects and to ensure the quality and integrity of the resulting data submitted to FDA. As part of this oversight, sponsors of clinical investigations are required to monitor the conduct and progress of their clinical investigations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-30/pdf/2018-26032.pdf?ref=fdaweb.com).