AUDIT REVIEW FOR INVESTIGATOR-INITIATED TRIALS INVOLVING AN

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

Principal Investigator:Date of review:

IRB #Auditor:

IDE #Protocol version date:

Study Title:

Questions / Yes / No / N/A / Comments
Sponsor-Investigator IDE Holders
Is the regulatory status of the device clear (classification, SR-significant risk or NSR-non-significant risk, etc)?
Is the intended route to market and the type of investigational exemption being sought clearly stated?
Is there a copy of the pre-IDE submission to the FDA on file, if applicable?
Is the pre-IDE response letter from the FDA on file, if applicable?
Is there a copy of the IDE submission to the FDA on file?
Is there an IDE confirmation letter on file with an IDE assignment # and Category A or B device determination indicated?
Is Sponsor-investigator/FDA correspondence on file?
Is the trial registered on if device is intended for the treatment of a serious or life-threatening disease or condition and you are conducting clinical trials to test its effectiveness)
Contact person:
Has a Form FDA 3674, Certificate of compliance been submitted to the FDA and a copy on File?
Has the CRCE (Clinical Research Compliance and Education) office reviewed and approved the MCA/NCD (Medicare Coverage Analysis/National Coverage Determination) pricing submission, if applicable?
Does the protocol include a description of plans for ongoing communication with the FDA and IRB such as annual reports, amendments, adverse device effects, etc.?
Does the PI have written verification of agreement to follow the protocol as written from each site participating, if applicable?
Informed Consent
Does the informed consent form for research subjects include all of the required elements? (This should be documented via IRB review and approval).
Are all IDE required procedures, if applicable, documented in the informed consent?
IRB / Sponsor Compliance
Is there a Financial Disclosure Form in ERICA or a Form FDA 3455 on file for each investigator listed on the 1572?
Are all versions of the protocol and consent complete and available for review?
Were the protocol, informed consent form, and relevant documents in compliance with the FDA, IRB and sponsor (if applicable) requirements?
If the study involves more than one investigator, has the name and address of the monitor been provided?
Are study personnel curriculum vitae (CV) and/or other relevant documents evidencing qualifications of primary investigator and co-investigator/s completed and on file for review?
Is the sponsor-investigator/IRB/sponsor (if applicable) correspondence on file?
Is the process to report protocol violations/deviations to the IRB included in the protocol?
Study Management
Is there a subject-screening log?
Is there a subject identification code list (enrollment log)?
Are there monitoring visit logs and report formsprepared and on file?
Is there a study staff signature list on file, if applicable?
Is the patient enrollment process identified in the protocol?
Is the process for recordkeeping outlined in the protocol?
Is there a staff training log?
Is there a delegation of tasks assignment sheet?
Is there a mechanism in place to record receipt, use and/or disposition of each device according to 21 CFR 812.140(a)?
ADE/IDE Safety Reporting
Is the process for the notification of unexpected and serious adverse deviceeffects to regulatory authorities and the IRB clearly identified in the protocol?
Is a Data and Safety Monitoring oversight committee identified and are the reporting instructions outlined in the protocol (if applicable)?
Is the process of reporting adverse device effects consistent with the regulations and instructions from the FDA in the IDEconfirmation letter?

Version date 9-28-09Page 1 of 5