An overview of the Clinical Investigator’s Brochure and the role it plays in clinical research.
The Investigator's Brochure
The role of the Investigator’s Brochure (IB) is to provide a complete summation concerning the information gathered during the investigation of a drug or medical device. This document provides an ongoing documentation of new information learned about the therapy or drug in question during trials. While the IB is designed to provide the investigator with relevant information needed to manage the trial, there are also legal requirements for the the proper documentation of the IB.
A brief description of the drug substance and the formulation, including the structural formula, if known.
(ii) A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
(iii) A summary of the pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.
(iv) A summary of information relating to safety and effectiveness in humans obtained from prior clinical studies. (Reprints of published articles on such studies may be appended when useful.)
(v) A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug (FDA, 2015).
This documentation is required prior to a study beginning. Once the study has begun there are other areas of documentation which must be maintained throughout the trial. Some of these vital information areas pertain to safety and clinical trial protocols including:
1. Dose (of the drug)- how much was used at various stages of the study.
2. Frequency of dosing- how often the dosages were given throughout the study.
3. Methods of administration- The methods of administration typically will only change if the study design calls for different methods of administration, e.g. intravenous or oral.
4. Safety monitoring procedures- At different stages of the study this will likely change and these methods must be updated in the IB (Colorado State University, 2015).
The IB provides an ongoing documentation which describes all aspects of the study. This area is not limited to information concerning the drug and its dosage and protocols. Any information concerning outcomes need to be documented and submitted. This means that the IB must be reviewed consistently for changes in information.
The sponsor is required to maintain the information in the IB. As new information concerning any aspect of the study becomes available it needs to be documented in the IB. As a result of regulations and guidance such as found in the International Conference on Harmonisation (ICH), the IB will likely contain much more information than what is required by regulation. However, since the IB is used to update other stakeholders such as Institutional Review Boards, documentation in this detail is necessary for meeting standards.
Colorado State University. (2015). Investigator’s Brochure. Retrieved from Colorado State University: http://ricro.colostate.edu/QA/InvestigatorsBrochure.html
FDA. (2015, April). CFR — Code of Federal Regulations Title 21. Retrieved from Food and Drug Administration: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23