The promoter is responsible for the selection of qualified instructors through training and experience to oversee the investigation study. The monitors can be collaborators of the sponsor or an organization charged by the promoter to carry out the tasks of the study monitor. A promoter must obtain a signed agreement from each participating examiner: the FDA 1572 form must be collected, in accordance with U.S. regulations, by all PNs for trials conducted as part of a test application (IND) that would include clinical trials of a test product or biological product, with the exception of device-related clinical trials (which require a similar form called an “investigative agreement,” which must be completed as part of a test device waiver application). 1. 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 the remaining delivery of the device to the sponsor or discard the device, as indicated by the proponent. The proponent must provide the following reports to the FDA, the IRB and/or the auditors in a timely manner. For more information on registration requirements, see the recordings. 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. The Investigator`s Statement (FDA Form 1572) is a form to be filled out for clinical trials with test drugs or biologic drugs. Through this form, IP provides the sponsor with specific information, including its qualifications and information on the clinical site, to ensure that the clinical trial is conducted in accordance with FDA rules and guidelines.

{1}By signing the 1572 form, IP is committed to meeting the FDA`s expectations: Clinical auditors must prepare the required reports: Section 6 is provided for the issuance of the names of individuals who are listed as investigators. After 21 CFR 312.3 (b), PI is the only leader of this team formed as part of a team study. All individuals who assist the IP and directly contribute to the implementation of the study procedures outlined in the protocol and when collecting data must be listed as sub-verifiers on FDA Form 1572. VAERS form – Used to report adverse vaccination events. 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. 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, an investigator or any person acting for or on behalf of a sponsor or examiner cannot: a promoter may only send control devices to qualified investigators who participate in the investigation.