Comprehensive training, organizational contacts, and meticulous hosting protocols for FDA inspections
Offering Category: Does your study involve an investigational drug or device?
A course introducing the regulatory responsibilities of sponsors and investigators in drug and device studies
Guide to optimize clinical trial oversight with vigilant protocol adherence and compliance, prepared for any sponsor, university, or regulatory audits
Details U-M Research Pharmacy’s standards for investigational drugs and approved exceptions with rigorous protocols to maintain the utmost safety and regulatory integrity in your clinical trials
Independent monitoring for IND/IDE investigator-initiated clinical trials
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics
Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations
FDA regulations for conducting clinical trials involving non-significant risk devices
A protocol template for investigator-initiated clinical drug trials (not to be used with medical device or hematology-oncology trials)
Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination