Overview
This lecture discusses the Investigator’s Brochure (IB), one of the essential documents in clinical research, its contents, importance, and responsibilities for its upkeep.
Essential Documents in Clinical Trials
- Essential documents include the Study Protocol, Investigator’s Brochure (IB), and Case Report Form (CRF).
- The IB is critical for informing investigators about the investigational product.
Investigator’s Brochure Contents
- The IB includes a title page with version number, summary, introduction, and detailed drug information.
- It provides an overview of physical, chemical, and pharmaceutical properties of the investigational product.
- Contains non-clinical data such as pharmacology, metabolism, and toxicology in animals.
- Includes clinical data if available, such as human pharmacokinetics, metabolism, safety, mode of use, marketing experience, data summary, and a manual for investigators.
- Guidance on recognizing and treating overdose and adverse reactions is included based on prior experience.
Use and Importance of the IB
- Investigators must always use the latest IB version for updated information.
- The IB is especially important in early clinical phases (e.g., phase one) with limited human data.
- All trial site staff making medical decisions must be familiar with the IB’s contents.
- Investigators must confirm receipt of the IB by signing a receipt form.
IB Maintenance and Regulatory Guidance
- The International Conference on Harmonization (ICH) provides detailed guidance on IB contents in the EU, Japan, and the US.
- The sponsor is responsible for keeping the IB up to date.
- The IB should be reviewed annually and updated with new or significant information, such as after marketing approval.
Key Terms & Definitions
- Investigator’s Brochure (IB) — A comprehensive document containing all known scientific and clinical data regarding an investigational product for investigators.
- Sponsor — The individual or organization responsible for initiating, managing, and updating the clinical trial and its documentation.
- Pharmacokinetics — The study of how a drug is absorbed, distributed, metabolized, and excreted in the body.
- Case Report Form (CRF) — A document used to record all information required by the clinical trial protocol for each subject.
Action Items / Next Steps
- Ensure you always use and are familiar with the latest version of the IB.
- Investigators should sign the IB receipt form upon receiving updates.
- Next topic: Review the Case Report Form (CRF).