IDE Sponsor Responsibilities

Responsibilities of Sponsors for Significant Risk Device Studies

General Duties: Sponsors are responsible for selecting qualified investigators and providing them with the information that they need to conduct the investigation properly. They must also ensure proper monitoring of the investigation and IRB review and approval, submit an IDE application to FDA for significant risk device studies, and inform the IRB and FDA promptly of any significant new information about the investigation.

FDA and IRB Approval (§812.42): A sponsor cannot begin an investigation or any part of an investigation until an IRB and FDA have both approved the application or supplemental application.
Selecting Investigators (§812.43): A sponsor is responsible for selecting investigators qualified by training and experience to investigate the device.
Selecting Monitors (§812.43): A sponsor must select monitors qualified by training and experience to monitor the investigational study in accordance with the IDE and other applicable FDA regulations.
Device Control (§812.43): A sponsor can ship investigational devices only to qualified investigators participating in the investigation.
Investigator Agreements (§812.43): A sponsor must obtain a signed agreement from each participating investigator that includes:

• the investigator's curriculum vitae,
• a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience, where applicable,
• an explanation of the circumstances that led to termination of a study if the investigator was involved in an investigation or other research that was terminated,
• a statement of the investigator's commitment to:
• conduct the investigation in accordance with the agreement, the investigational plan, the IDE and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA,
• supervise all testing of the device involving human subjects. and
• ensure that the requirements for obtaining informed consent are met.
• sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 CFR 54, Financial Disclosure by Clinical Investigators.

Informing investigators (§ 812.45): A sponsor must supply all investigators participating in the investigation with copies of the investigational plan and a report of prior investigations of the device.
Monitoring (21 CFR 812.46)

• Selecting monitor(s) qualified by training and experience to monitor the progress of the investigation
• Securing compliance of all investigators in accordance with the signed investigator's agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any condition of approval imposed by the reviewing IRB or FDA. If compliance cannot be secured, shipment of the device to the investigator and the investigator's participation in the investigation must be discontinued
• Ensuring that significant new information about the investigation is provided to all reviewing IRBs, FDA, and investigators
• Evaluating all unanticipated adverse device effects and terminating the investigation, or portions of it, if that effect presents an unreasonable risk to subjects (reporting requirements are listed below.)
• Resuming terminated investigations only after both FDA and IRB approvals are obtained.

Sponsor records (§ 812.140): The sponsor must maintain accurate and complete records relating to the investigation. These records include:

• all correspondence including required reports,
• records of shipment of the device,
• records of disposition of the device
• signed investigator agreements including financial disclosure information,
• records concerning complaints and adverse device effects whether anticipated or not,
• any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.

Sponsor Reports (§812.150): The sponsor must provide the following reports in a timely manner to FDA, the IRB's, and/or the investigators.

• Unanticipated Adverse Device Effects
• Withdrawal of IRB Approval
• Withdrawal of FDA Approval
• Current List of Investigators
• Progress Reports
• Recalls and Device Disposition
• Final Report
• Informed consent
• Significant Risk Device Determination
• Other Reports

Labeling (§812.5):The sponsor should provide detailed information on device labeling in the investigational protocol. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.
Promotion of Investigational Devices (§812.7): Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:

• Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
• Commercialize an investigational device by charging the subjects or investigators a higher price than that necessary to recover costs of manufacture, research, development, and handling.
• Unduly prolong an investigation. If data developed by the investigation indicate that premarket approval (PMA) cannot be justified, the sponsor must promptly terminate the investigation.
• Represent that an investigational device is safe or effective.

However, the sponsor may advertise for research subjects to solicit their participation in a study. Appropriate advertising methods include but are not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects.

Responsibilities of Sponsors of Nonsignificant Risk Device Studies

Sponsors of nonsignificant risk studies must comply with the abbreviated IDE requirements set forth in (§812.2(b). The sponsor must:

• Obtain IRB approval of the investigation as a nonsignificant risk device study after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device and maintain such approval.
• Ensure that each investigator participating in an investigation of the device obtains informed consent under 21 CFR 50 for each subject under the investigator’s care and documents the consent, unless documentation is waived by an IRB under §56.109(c).
• Comply with the requirements of §812.46 with respect to monitoring investigations.
• Label the device in accordance with §812.5. The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.
• Maintain certain records and submit required reports.
• Ensure that participating investigators maintain the records of each subject’s case history and exposure to the device under §812.140(a)(3)(i) and ensure that participating investigators make the following required reports to the sponsor:
• Unanticipated Adverse Device Effects [§812.150(a)(1)]
• Withdrawal of IRB Approval [§812.150(a)(2)]
• Failure to obtain informed consent [§812.150(a)(5)]
• Other reports requested by a reviewing IRB or FDA [§812.150(a)(7)]
• Comply with the prohibitions in §812.7 against promotion and other practices.

Source:

www.fda.gov

Related Training:

Clinical Trials Process: Study Sponsor's and Investigator's Responsibilities
The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions