FDA Corner

IND/IDE Holder Information:

If you are the holder of an IND/IDE (a.k.a. Sponsor-Investigator), you assume the responsibilities of both an investigator AND a sponsor. The QI Program can assist you in ensuring compliance with FDA regulations governing sponsor-investigators.

The QI Program has developed a checklist as well as other relevant tools that will help you to meet the FDA requirements and be ready for an unexpected audit. The best way for the QI Program to help you is through an on-site review, during which the QI staff will guide you through your responsibilities including setting up essential documents, data collection, record keeping, monitoring activities and FDA reporting requirements. This type of on-site review usually takes between 2 - 4 hours.

If you would like to schedule a review/consultation, or are interested in learning more about our service, please contact Sarah White at 617-424-4137.

IND/IDE Submission Content

• IND/IDE Basic
• IND Submission Format
• IDE Submission Format

FDA Guidance Information:

Completion guidelines for FDA Forms 1571, 1572, and 3674 (new)

Certification requirements to accompany drug, biologics and device submissions in association with the Clinical Trial Registrations (new)

Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials (new)

Frequently Asked Questions - FDA Form 1572 (new draft guidance)

HDE Holders (new draft guidance)

Safety Information and Adverse Event Reporting (new)

Investigational Device Advice

Good Clinical Practice in FDA-Regulated Clinical Trials

FDA Information Sheets

Additional Useful FDA Guidances (new)

Useful Forms:

FDA Form 3674 - Certficate of Compliance w/ Requirements of ClinicalTrials.gov Data Bank (new)

FDA Form 3500A - Adverse Event Reporting

FDA Form 3454 - Certifcation of Absence of Reportable Financial Interest

FDA Form 3455 - Financial Disclosure

FDA Form 1571 - Cover Letter to FDA

FDA Form 1572 -Statement of Investigator

Drug Accountability Log

Device Accountability Log

FDA Communication Log

Coordinating Center Regulatory checklist

FDA Electronic Forms Page

Regulatory Information:

Protection of Human Subjects 45 CFR 46 - OHRP

Protection of Human Subjects 21 CFR 50

Electronic Records; Electronic Signatures 21 CFR 11

Financial Disclosure By Clinical Investigators 21 CFR 54

Institutional Review Boards 21 CFR 56

Investigational New Drug Application 21 CFR 312

Investigational Device Exemptions 21 CFR 812

Other Useful Information:

Partners 21 CFR Part 11 Compliance Letter (new)

IDE Investigator Agreement

FDA Most Recent Warning Letters (new)

FDA Contacts for IND/IDE Questions (new)

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