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 promoter, examiner or any person acting for or for a sponsor or examiner cannot do so: the IDE regulation requires the promoter to identify the name and address of the monitor and to put in place written monitoring procedures. 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. Once the investigators and institutions have been identified and selected, the promoter must enter into a legal agreement or contract with the site where the process is to be carried out. This is most often referred to as the clinical study agreement. The agreement should include the following conditions: at the end or end of a clinical examination or part of the examiner`s examination or at the request of the proponent, an examiner must return to the promoter the remaining delivery of the device or discard the device, as the proponent indicates. A sponsor is responsible for selecting qualified investigators through training and experience to examine the device. An examiner may only authorize the use of the examination device for persons under his authority and cannot provide an investigative facility to persons who are not authorized to receive it under FDI rules. Clinical auditors must prepare the following necessary reports: proponents are responsible for selecting qualified investigators and providing 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. An examiner is responsible for obtaining consent under 21 CFR Part 50. 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 allocation of roles and responsibilities should also include the following elements in the agreement (if any): A proponent who finds that an examiner is not complying with the signed agreement, the protocol, FDA requirements, all other applicable FDA rules or the conditions of approval imposed by the IRB or FDA verification must, without delay, ensure compliance with the device. , or stop transferring the device to the auditor and terminate the examiner`s involvement in the investigation. A promoter must also require the examiner to dispose of the device or return it, unless it jeopardizes the rights, safety or well-being of a subject. The monitor is responsible for ensuring compliance with FDI requirements. The monitor must ensure that inspectors comply with the signed agreement, protocol, FDI requirements, all other applicable FDA requirements or licensing requirements imposed by the IRB or FDA audit.