In conducting clinical investigations of drugs, including biological products, under 21 CFR part 312 and of medical devices under 21 CFR part 812, the investigator is responsible for:
- Ensuring that a clinical investigation is conducted according to the signed investigator statement for clinical investigations of drugs, including biological products, or agreement for clinical investigations of medical devices, the investigational plan, and applicable regulations
- Protecting the rights, safety, and welfare of subjects under the investigator’s care
- Controlling drugs, biological products, and devices under investigation (21 CFR 312.60, 21 CFR 812.100)
As a reminder, some investigators may be responsible for submitting certain clinical trial information to the National Institutes of Health clinical trials data bank under 42 U.S.C 282(j), 402(j) of the Public Health Service Act. Although not all investigators will be expected to meet this requirement, go to www.clinicaltrials.gov for further information about potential responsibilities.
Although specific investigator responsibilities in drug and biologics clinical trials are not identical to the investigator responsibilities in medical device clinical trials, the general responsibilities are essentially the same. This guidance discusses the general investigator responsibilities that are applicable to clinical trials of drugs, biologics, and medical devices.
An investigator’s responsibilities in conducting clinical investigations of drugs or biologics are provided in 21 CFR Part 312. Many of these responsibilities are included in the required investigator’s signed statement, Form FDA-1572 (see Attachment A) (hereinafter referred to as 1572). Note that although the 1572 specifically incorporates most of the requirements directed at investigators in part 312, not all requirements are listed in the 1572. Investigators and sponsors should refer to 21 CFR Parts 11, 50, 54, 56, and 312 for a more comprehensive listing of FDA’s requirements for the conduct of drug and biologics studies.2
An investigator’s responsibilities in conducting clinical investigations of a medical device are provided in 21 CFR Part 812, including the requirement that there be a signed agreement between the investigator and sponsor (see 21 CFR 812.43(c)(4) and 812.100). The medical device regulations do not require use of a specific form for an investigator’s statement; and there are additional requirements not listed above (see Attachment B). Investigators and sponsors should refer to 21 CFR Parts 11, 50, 54, 56, and 812 for a more comprehensive listing of FDA’s requirements for the conduct of device studies.
Nothing in this guidance is intended to conflict with recommendations for investigators contained in the International Conference on Harmonisation (ICH) guidance for industry, E6 Good Clinical Practice: Consolidated Guidance (Good Clinical Practice Guidance).
Clarification of certain investigator responsibilities