I have to admit I inherently know what is meant by the 1572 Investigator Commitments, but it has been some time since I read them, line by line. I did so recently during an inspection. There is a lot the PI agrees to do, let’s review them:
-I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
-I agree to personally conduct or supervise the described investigation(s).
-I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met.
-I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64. I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.
-I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments.
-I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in accordance with 21 CFR 312.68.
-I will ensure that an IRB that complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others. Additionally, I will not make any changes in the research without
IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
-I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312
What does all this mean?
As the sponsor, we have an obligation to the PI, to provide all the necessary documents to ensure the PI understands the expectations: protocol, IB, ICFs and any additional documents for full disclosure.
The PI agrees to follow the protocol, comply with ICH GCP, conduct the work personally or directly supervise the study activities, report any issues as required, and ensure there is ethics committee oversight, for the safety of clinical trial subjects.
This means there is a partnership and a contract that has been entered into. Sponsors will provide full disclosure as well as the PI and conduct the study as indicated in the protocol.
Have you reviewed and read these commitments? Have you had any challenges with PIs following through on these? How do they respond if you remind them of these, if there is a reason to think there may be non-compliance.
Let me know if this has helped you, I’d love to hear from you!
Reference:Â http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf