Securing IDE approval is only the first step—sponsors must ensure IRB oversight, qualified investigators, trial monitoring, device accountability, and timely reporting. Strict compliance safeguards subjects, data integrity, and the IDE’s standing with FDA.
Securing the IDE approval is a major milestone, but sponsors must adhere to strict responsibilities throughout the clinical trial. FDA and IRBs expect diligent oversight to protect subjects and ensure data integrity. Non-compliance can result in IDE withdrawal or regulatory action. Here are the key sponsor duties once an IDE is in effect:
Every clinical site must have Institutional Review Board (IRB) approval of the study, and that approval must be kept current (typically renewed annually) for as long as the site is enrolling or following subjects. No study activities can start at a site until both FDA IDE approval and IRB approval are in place. The sponsor is responsible for providing each IRB with any updated information (e.g., IDE approval letter, protocol amendments, safety reports) and for ensuring no patients are enrolled at non-approved sites. If an IRB ever withdraws approval (for example, due to a safety concern), the sponsor must halt the study at that site and inform FDA of the IRB’s decision within 5 working days.
Sponsors must select qualified investigators (experience and training appropriate for the device) and obtain their commitment to follow the investigational plan and regulations. This is usually done via a signed Investigator Agreement (submitted in the IDE). The sponsor should ensure each investigator gets the latest investigator brochure, device manual, and the IRB-approved protocol and consent forms. If any investigator is not complying, the sponsor must take corrective action (up to removing the investigator).
Per 21 CFR 812.46, sponsors are required to monitor the study to ensure it is conducted per the protocol and regulations. This involves appointing monitors (clinical research associates) who will visit sites, review consent forms, verify data accuracy against source documents, and check for compliance issues. Sponsors should have a monitoring plan (frequency of visits, etc.). If a monitor discovers serious non-compliance – e.g., an investigator not following the protocol or not reporting adverse events – the sponsor must act quickly to secure compliance or terminate that investigator’s participation. Proper monitoring is not just a regulatory obligation but also protects the quality of your data.
The sponsor must control the investigational devices and ship them only to participating investigators. You need to keep records of device shipment, use, and disposal. Investigators should return or destroy any remaining devices at study end (unless they are needed for continued access or have been accounted for). This prevents unauthorized use of the device outside the trial.
Sponsors have several reporting obligations during an IDE study (per 21 CFR 812.150):
The sponsor must maintain complete records of the trial as described in 21 CFR 812.140(b). This includes:
These records must be maintained in a way that they can be readily inspected by FDA. FDA inspections of sponsors or clinical sites can occur during or after the trial (as part of Bioresearch Monitoring). Being organized and compliant will make any inspection go much smoother.
A sponsor is also responsible for ensuring investigators fulfill their obligations (21 CFR 812.100 & 812.110). That means the sponsor should educate investigators on their duties, which include obtaining informed consent, following the protocol, reporting all required info to the sponsor/IRB, etc. For instance, investigators must report any unanticipated adverse device effect to the sponsor within 10 working days of occurrence, enroll only eligible patients, and only use the device as per the investigational plan. If an investigator is non-compliant, as mentioned, the sponsor must either correct it or discontinue use of the device by that investigator.
During the IDE, the device is investigational – promotion or commercialization is prohibited. Sponsors cannot market the device or claim safety/effectiveness beyond stating it is experimental. Advertising for trial recruitment is allowed (with IRB approval), but it must be clear that the device is investigational. Also, charging for the device is only allowed to recover costs of manufacture and R&D; it must be justified in the IDE (and FDA will object if the price seems profit-making).
By fulfilling these responsibilities, sponsors uphold Good Clinical Practice (GCP) and maintain the IDE in good standing. Remember, an IDE can be withdrawn by FDA if, for example, the sponsor fails to submit required reports or if continuing the study presents unreasonable risk. Thus, regulatory compliance during the trial is as important as obtaining the IDE approval in the first place.
In summary, think of IDE sponsor duties in three broad categories: (1) managing oversight (IRBs and investigators), (2) monitoring and controlling the study and device, and (3) reporting to regulators. By excelling in these, you not only satisfy legal requirements but also help ensure the trial runs safely and produces credible data for your eventual marketing submission.
