Clinical Trial Investigator Agreement
A promoter, examiner or person acting for or on behalf of a sponsor or examiner may not do so under section 812.7: at the end or end of a clinical examination or part of the examiner`s examination or at the request of the promoter, an examiner must return to the promoter the remaining delivery of the device or discard the device as the sponsor manages it. “Sample Commitment Statement of an Individual Investigator to Institutional Human Subject Protection Policies and IRB Oversight A proponent must obtain a signed agreement from each participating examiner that requires sponsors to select qualified examiners and provide them with the information they need to complete the investigation. They must also ensure that the investigation and verification and accreditation of the IRB is properly monitored, that they submit an FDI application to the FDA for studies of significant risk devices, and that they immediately inform the IRB and FDA of any important new information regarding the investigation. The investigator is responsible for the protection of the rights, safety and well-being of the subjects. An examiner conducts the review in accordance with the agreement signed with the sponsor, the protocol, the FDI rules and other applicable FDA rules, and all licensing requirements imposed by an IRB and FDA. (No. 812.100) A sponsor must provide all investigators involved in the investigation with copies of the investigation plan and a report on previous investigations into the aircraft. The IDE regulation stipulates that the promoter must identify the name and address of the monitor and that written monitoring procedures are provided. While FDI rules do not specify the content of written monitoring procedures, the FDA has issued the following guidelines to help sponsors develop such procedures. The guidelines for the creation and operation of Clinical Data Monitoring Committees (CMDs) are intended to help clinical trial proponents determine when a CMD can be useful in monitoring studies and how these committees should work. In addition, monitoring of clinical investigations – A risk-based approach to monitoring sponsors in the development of risk-based surveillance strategies and plans must be supported.