AddtoAny General responsibilities of investigatorsWhile the Common Rule does not enumerate specific investigator responsibilities, OHRP has provided a set of Frequently Asked Questions on that covers their interpretation of these responsibilities. Show
In contrast, the FDA regulations do include specific investigator responsibilities. These are listed in 21 CFR 312.60-69.pdf. 21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter. Through the act of submitting a protocol to the IRB, and being named as the principal investigator (PI) of that study, the PI is agreeing to assume the overall responsibility for the study conduct. By doing so, they are agreeing to:
There are numerous links to terms on this page which go to other webpages on the IRB's website with more details and more information. At present the most comprehensive discussion of the investigator's responsibilities is the FDA's Guidance document Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. The process starts with the decision to perform the study, the design of the study, the communications with the IRB, the oversight of the study execution, the analysis and reporting of data, and the storage of the study data after study completion. Overview of Principal Investigator ResponsibilitiesThe principal investigator is responsible for knowing the research regulations that apply to their study, additional requirements imposed by the funding agency, study sponsor and relevant regulatory authority (e.g. adverse event reporting, progress reports). ICH Good Clinical Practice - Investigator ResponsibilitiesThe International Conference on Harmonisation (ICH) documents, serve as guidance for the conduct of all FDA-regulated drug, biologic and device clinical trials. ICH E6 Guideline for Good Clinical Practice enumerates the specific responsibilities of the study investigator. While ICH E6 goes beyond what might be necessary for many minimal risk clinical research studies, it is still a useful reference for investigators. Section 4 in particular, outlines the investigator's responsibilities; these cover the following areas:
Responsibilities Related to the Conduct of Human Subjects ResearchThe principal investigator is responsible for ensuring that:
Responsibilities Related to the IRBThose responsibilities that relate to the IRB are covered in IRB SOP 801: Investigator Responsibilities. Resources to Assist with PI ResponsibilitiesWhich of the following are investigator responsibilities?21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the ...
Which of the following are GCP responsibilities of the investigator?What is GCP?. Ensures that the rights, safety, and well-being of study participants are protected.. Ensures the integrity of the data submitted for approval.. Sets standards for a system of mutual accountability among sponsors, regulatory authorities, investigators, and IRBs.. What are the responsibilities of the principal investigator of a study?The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships.
Who has ultimate responsibility for an investigational device at the site?1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.
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