Frequently Asked Questions

Browse the links below to find answers to frequently asked questions (FAQs) questions. Please email  ECS-HSR@pitt.edu for any topic or question not answered. 

Monitoring & Compliance Support FAQs 

Get answers to your FAQs about Monitoring and Compliance Support such as source documentation, preparing for an FDA or regulatory audit, Principal Investigator Responsibilities, and more. 

Clinical Trial Registration and Transparency Support FAQs

Get answers to your FAQs about ClinicalTrials.gov, registration, maintenance, submitting study results, and more. 

IND & IDE Support FAQs 

Get answers to your FAQs about the submission of IND and IDE applications, submitting protocol modifications to the IRB and/or FDA, and more.