What must be included in a Clinical Investigation Plan (CIP)?

A Clinical Investigation Plan (CIP) is a comprehensive document that outlines the strategy, objectives, methodology, and organizational structures for a clinical trial. The inclusion of a clinical investigation protocol is essential because it serves as the foundational framework for the study. The protocol provides detailed information on the trial’s design, objectives, statistical considerations, and participant management, ensuring that the study is conducted systematically and in compliance with regulatory standards.

This document is crucial not only for guiding the conduct of the trial but also for ensuring that all stakeholders, including regulatory bodies, ethical committees, and the study team, understand the study’s objectives and procedures. By detailing how the investigation will be conducted, the protocol helps maintain the integrity of the research and ensures patient safety is prioritized throughout the trial.

On the other hand, while a clinical investigator's brochure, investigator qualifications, and informed consent forms are important documents that support the clinical investigation, they do not constitute the core component of the CIP. The brochure provides background information on the investigational product, qualifications affirm the research capabilities of the investigator, and informed consent forms ensure that subjects are adequately informed about the study risks and procedures. However, these elements are supplementary to the primary structure and guidelines established within the clinical investigation protocol.