Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-31261 · Docket No. FDA-2023-D-5016

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.” This draft guidance provides recommendations to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations. The guidance provides definitions for protocol deviations and important protocol deviations. In addition, the guidance provides a recommended classification system for sponsors to report protocol deviations to FDA in clinical study reports for drugs, biological products, and devices; for investigators to report protocol deviations to sponsors and to IRBs; and for IRBs to evaluate protocol deviations.

Dates

Submit either electronic or written comments on the draft guidance by February 28, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.” Protocols document the study design, objectives, population, planned procedures, investigational product management, method(s) of data capture, monitoring and oversight plans, and statistical analysis plans either directly or by reference to associated investigational plans. In the conduct of a clinical investigation, some deviations from the specifics outlined in the protocol may occur. This guidance provides recommendations to assist sponsors, clinical investigators, and IRBs in defining, identifying, and reporting protocol deviations. FDA regulations do not include a definition of the term protocol deviation or provide a system for classifying the various types of deviations that may occur during the conduct of a clinical investigation. A system that applies consistent classification, reporting, and documentation standards is important to assure the most interpretable and useful information emerges from the reporting of protocol deviations. To address these considerations, this guidance includes (1) definitions for protocol deviations and important protocol deviations, (2) recommendations on the types of protocol deviations that sponsors should report to FDA in clinical study reports, (3) recommendations on the types of protocol deviations that investigators should report to sponsors and to IRBs, and (4) recommendations for IRBs in their evaluation of protocol deviations. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 320 have been approved under OMB control number 0910-0291; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov. Dated: December 17, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024-31261 Filed 12-27-24; 8:45 am]