Articles tagged with “ind-application”

Investigator-Initiated Trials (IITs): A Guide to Sponsorship

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials.

40 min read

11/22/2025

investigator initiated trial sponsor-investigator clinical trial sponsorship academic clinical trials gcp guidelines fda regulations ind application

What is an Investigator's Brochure (IB)? A GCP Guide

Learn what an Investigator's Brochure (IB) is, its required content per ICH GCP guidelines, and its critical role in assessing risk for clinical trials.

35 min read

11/19/2025

investigator's brochure clinical trials gcp ich e6 regulatory affairs ind application drug development investigational product