CP 7348.810 Sponsors and CROs - US Food and Drug A
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CP 7348.810 Sponsors and CROs - US Food and Drug Administration
page 8
B. PROGRAM MANAGEMENT INSTRUCTIONS 1. Coverage This program covers domestic and foreign inspections of: a. Sponsors Such entities that take responsibility for and initiate clinical investigations4 and/or have been so identified by FDA through receipt of an investigational exemption, or application for research or marketing permit. A sponsor is defined in the regulations at 21 CFR 58.3(f), 312.3(b), 510.3(k), 511.3, and 812.3(n). b. Contract Research Organizations (CROs) Such entities to whom one or more of the obligations of a sponsor have been transferred in writing5 (e.g., design of protocol, selection of investigators and study monitors, monitoring, evaluation of reports, preparation of materials to be submitted 4 21 CFR 312.3, 511.3, and 812.3(i) 5 Transfer of responsibility is permitted by written agreement. Responsibilities that are not specified in a written agreement are not considered to be transferred. When operating under written agreements, the CROs are subject to the same regulatory actions as sponsors for any failure to perform any of the obligations assumed.
https://www.fda.gov/media/75916/download
page 8
B. PROGRAM MANAGEMENT INSTRUCTIONS 1. Coverage This program covers domestic and foreign inspections of: a. Sponsors Such entities that take responsibility for and initiate clinical investigations4 and/or have been so identified by FDA through receipt of an investigational exemption, or application for research or marketing permit. A sponsor is defined in the regulations at 21 CFR 58.3(f), 312.3(b), 510.3(k), 511.3, and 812.3(n). b. Contract Research Organizations (CROs) Such entities to whom one or more of the obligations of a sponsor have been transferred in writing5 (e.g., design of protocol, selection of investigators and study monitors, monitoring, evaluation of reports, preparation of materials to be submitted 4 21 CFR 312.3, 511.3, and 812.3(i) 5 Transfer of responsibility is permitted by written agreement. Responsibilities that are not specified in a written agreement are not considered to be transferred. When operating under written agreements, the CROs are subject to the same regulatory actions as sponsors for any failure to perform any of the obligations assumed.
https://www.fda.gov/media/75916/download
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