The monitor is responsible for ensuring compliance with the requirements of the IDE (§ 812.46). The monitor must ensure that inspectors comply with the signed agreement, test plan, IDE requirements, any other applicable FDA rules, or any certified conditions imposed by the IRB or FDA verification. A sponsor must obtain from each participating examiner a signed agreement that includes that the examiner is responsible for the protection of the rights, safety and well-being of the subjects. An examiner must conduct the investigation in accordance with the agreement signed with the sponsor, the test plan, the IDE rules and other applicable FDA rules, as well as any approval conditions imposed by an IRB and the FDA. (§812.100) At the end or end of a clinical trial or part of the trial conducted by the reviewer or at the request of the sponsor, a reviewer must return to the sponsor all remaining deliveries of the product or, in the opinion of the sponsor, dispose of the product. A sponsor must provide all investigators involved in the survey with copies of the test plan and a report on previous product studies. Ensure compliance: Any sponsor who finds that an examiner is not complying with the signed agreement, test plan, IDE requirements, other applicable FDA rules, or conditions of authorization imposed by the control IRB or FDA must immediately ensure compliance, either stop delivering the product to the reviewer and terminate the examiner`s participation in the investigation. A sponsor must also require the examiner to dispose of or return the device, unless doing so would compromise the rights, safety or well-being of a subject. A sponsor is responsible for selecting investigators qualified by training and experience to study the device. Clinical trials must provide the following necessary reports: The clinical trial must provide the sponsor with sufficient accurate financial information to enable the applicant (or sponsor) to obtain certification or disclosure of financial interests in accordance with 21 CFR 54. The auditor must update the information in case of relevant changes during the investigation and for one year after the end of the study.
In accordance with Article 812.7, a sponsor, examiner or person acting for or on behalf of a sponsor or examiner may not: sponsors are responsible for selecting qualified examiners and providing them with the information necessary to properly conduct the investigation. . . .