IDE Investigator Responsibilities

Responsibilities of Investigators for Significant Risk Device Studies

The investigator is responsible for protecting the rights, safety, and welfare of subjects. An investigator must conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, the IDE regulations and other applicable FDA regulations, and any conditions of approval imposed by an IRB and FDA. (§812.100)

While awaiting approval of an IDE application, an investigator may determine whether or not potential subjects would be interested in participating in an investigation, but cannot request written informed consent or allow any subjects to participate before obtaining IRB and FDA approval. (§812.110)

Informed Consent: An investigator is responsible for obtaining informed consent under 21 CFR Part 50.
Supervision of Device Use (§812.110): An investigator can permit use of the investigational device only with subjects under his/her supervision and cannot not supply an investigational device to any person not authorized under the IDE regulations to receive it.
Financial Disclosure (§812.110): The clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the IDE applicant (or sponsor) to submit certification or disclosure of financial interests under 21 CFR 54. The investigator must update the information if any relevant changes occur during the course of the investigation and for one year following completion of the study.
Device Disposal (§812.110): Upon completion or termination of a clinical investigation or the investigator's part of the investigation or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or dispose of the device as the sponsor directs.
Records (812.140): The investigator must maintain accurate and complete records relating to the investigation. These records include:

• all correspondence including required reports
• records of receipt, use, or disposition of the investigational device
• records of each subject's case history and exposure to the device
• the protocol and documentation (date and reason) for each deviation from the protocol
• any other records that FDA requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation

Responsibilities of Investigators for Nonsignificant Risk Device Studies

Informed Consent: An investigator is responsible for obtaining informed consent under 21 CFR Part 50.
Records: Clinical investigators must maintain the records of each subject’s case history and exposure to the device under §812.140(a)(3)(i). Case histories include case report forms and supporting data, including signed and dated consent forms and medical records, including progress notes of the physician, the individual’s hospital chart(s), and the nurses’ notes. Records must include documents demonstrating informed consent and, for any use of a device the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. The case history of each individual must document that informed consent was obtained prior to participation in the study.
Reports: Clinical investigators must make the following required reports:

• 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)]

Financial Disclosure: If the data in a nonsignificant risk device study is submitted in a marketing application, then 21 CFR 54, Financial Disclosure, applies. The clinical investigator must disclose to the sponsor sufficient accurate financial information to allow the IDE applicant (or sponsor) to submit certification or disclosure of financial interests. The investigator must update the information if any relevant changes occur during the course of the investigation and for one year following completion of the study. (§ 812.110)

Source:

www.fda.gov

Related Training:

Investigator Responsibility/Legal Commitment in Drug and Device Clinical Research
Responsibilities of a Principal Investigator in Clinical Trials
GCP and FDA Regulations with regard to Investigator Responsibility