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Investigator Responsibilities - Devices

An investigator's responsibilities in conducting clinical investigations of a medical device are stated in 21 CFR 812.

These include the requirement that there is a signed agreement between the investigator and the sponsor. Additional requirements are also contained in 21 CFR 50 (Informed Consent Process), and 21 CFR 56 (IRB regulations), and sections of 21 CFR 312.

The investigator, as documented in the signed agreement between the investigator and sponsor, has the following commitments:

  • To conduct the investigation in accordance with
    • The signed agreement with the sponsor
    • The investigational plan (protocol and other relevant documentation)
    • The regulations in 21 CFR 812 and other applicable regulations
    • Any conditions of approval imposed by the reviewing IRB or FDA
  • To supervise all testing of the device including human subjects (21 CFR 812.43 (c)(4)(ii))
  • To ensure that the requirements for obtaining informed consent are met (21 CFR 812.43(c)(4)(iii) and 21 CFR 812.100)
In addition to following the signed agreement, the investigator's responsibilities include:
  • To permit an investigational device to be used only with subjects under the investigator's supervision and to supply an investigational device only to persons authorized to receive it (please refer to Delegation of Authority and Supervision of the Conduct of a Clinical Investigation)
  • To return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs upon completion or termination of the a clinical investigation or the investigator's part of an investigation
  • To maintain accurate, complete, and current records related to the investigator's participation in the study
    • All correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA, including required reports
    • Records of receipt, use, and disposition of a device
    • Records of each subject's case history and exposure to the device
    • The protocol, with documentation of the dates of and reasons for each deviation from the protocol
    • Any other records which the FDA requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation
  • To permit the FDA to inspect and copy any records pertaining to the investigation including, in certain circumstances, those which identify subjects
  • To prepare and submit to the sponsor and, when required by regulation, the reviewing IRB and monitor, the following complete, accurate, and timely reports
    • Any unanticipated adverse device effect occurring during an investigation
    • Progress reports on the investigation
    • Any deviation from the investigational plan made to protect the life or physical well-being of a subject in an emergency
    • Any use of the device without obtaining informed consent
    • A final report
    • Any further information requested by FDA or the IRB about any aspect of the investigation
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