Regulatory & Documentation
Investigator-Initiated Trial (IIT)
An Investigator-Initiated Trial (IIT) is a clinical trial in which an academic or independent investigator (rather than a pharmaceutical or device sponsor) serves as the regulatory sponsor, holds the IND, and is responsible for protocol design, conduct, and reporting.
IITs typically address scientific questions outside a pharma sponsor's commercial roadmap; investigator-led comparative effectiveness, mechanism-of-action, repurposing, or rare-disease studies. Pharma companies often provide drug supply and partial funding through formal IIT or ISR programs.
Investigators serving as sponsor-investigators take on the full sponsor regulatory burden under 21 CFR 312, including IND submission, IB maintenance, monitoring, and pharmacovigilance.
Related terms
IND Application (Investigational New Drug)
An Investigational New Drug (IND) application is the submission a sponsor files with the FDA to obtain authorization to ship an unapproved drug across state lines and to administer it to humans in a clinical trial.
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo