a. Prior Investigations (21 CFR §812.27). This section should summarize any prior clinical testing experience by the sponsor with the test device. Additional information could be included from bench, in vitro and in vivo tests that support the proposed clinical trial. Relevant literature data on safety and effectiveness should also be summarized, including a bibliography of all published material.
b. Responsibility of the Sponsor (21 CFR §812 Subpart C). This section describes the general responsibilities of the study sponsor, including securing the FDA/IRB approvals, selection of qualified investigators and monitors, obtaining signed agreement from the investigator, details on the monitoring procedures, procedures for reporting unanticipated device effects to the agency and IRB, providing periodic reports (annual reports to FDA), procedures on how investigational devices will be controlled, that is, records for shipping and receiving and calibration and maintenance records.
c. IRB Review (21 CFR §812 Subpart D). This section should briefly describe the IRB composition, duties, and function. An IRB is responsible for protecting the rights and welfare of the subjects participating in the study. An IRB approval is required for subject recruitment (any form of advertisement to recruit subjects), consent form, and the clinical protocol. Sponsor is responsible for determining whether the device is a significant or a nonsignificant risk device. The IRB must agree with this determination.
d. Responsibilities of Investigators (21 CFR §812 Subpart E). This section should briefly describe the responsibilities of the investigator in conducting the clinical trial. The regulatory definition of an investigator is “… an individual who actually conducts a clinical investigation, i. e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or in the event of an investigation conducted by a team of individuals, is the responsible leader of the team”.
The general responsibilities of the investigator include conducting the clinical trial according to the investigational plan, supervising the device use, and protecting the rights, and safety and welfare of the subjects enrolled in the study. The investigator also ensures that appropriate approvals from the FDA and IRB are in place before initiating the study.
e. Records and Reports (21 CFR §812 Subpart G). This section briefly describes what records would be created and maintained.