Did you know the FDA issued proposed guidance on certification requirements to accompany drug, biologics and device submissions in association with the Clinical Trial Registrations?
Click here to learn more from the draft guidance document posted on the FDA website.
A copy of the certification form (FDA Form 3674) can be downloaded by clicking on the link below on the Useful Templates section.
Are you an IND Holder?
If you are the holder of an IND (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 Julie Kaberry at 617-424-4138 or Sarah White at 617-424-4137.
IND Submission Content
Useful Templates:
FDA Form 3674 (new)
Cover Letter to FDA (Form 1571)
Useful Links:
Frequently Asked Questions - FDA Form 1572 (new draft guidance)
Good Clinical Practice in FDA-Regulated Clinical Trials
Protection of Human Subjects 21 CFR 50
Protection of Human Subjects 45 CFR 46 - OHRP
Investigational New Drug Application 21 CFR 312
Investigational Device Exemptions 21 CFR 812
Electronic Records; Electronic Signatures 21 CFR 11