Regulatory & Documentation
Investigational Product (IP)
An Investigational Product (IP) is the pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products with marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form.
IP handling is governed by ICH E6(R3), ICH Q7, and Annex 13 of the EU GMP Guide. Sponsors must ensure proper labeling, blinding, temperature-controlled storage, accountability logs, and appropriate destruction or return at study end.
IRT systems automate IP randomization, dispensing, and resupply forecasting based on enrollment velocity.
Related terms
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.
Investigator Brochure (IB)
An Investigator's Brochure (IB) is the comprehensive document, updated at least annually, that summarizes all available clinical and non-clinical data on an investigational product, allowing investigators to assess the benefit-risk balance for trial participants.
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.
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