Investigator Brochure (IB)
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An Investigator Brochure (IB) is a Document that summarizes information about an investigational product obtained during a clinical trial.
- Example(s):
- Counter-Example(s):
- See: Medical Device, Drug Development Clinical Trial, Clinical Trial Protocol, Good Clinical Practice, U.S. Food And Drug Administration, International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use, Good Clinical Practice.
References
2022a
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Investigator's_brochure Retrieved:2022-3-25.
- In drug development and medical device development the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials. An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: * Dose (of the study drug)
- Frequency of dosing interval
- Methods of administration
- Safety monitoring procedures
- An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product".
The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the authoring of the IB in the European Union (EU), Japan, and the United States (US).
- In drug development and medical device development the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials. An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: * Dose (of the study drug)
2022b
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-25.
- Investigator's Brochure
- A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects. (ICH E6)
- Investigator's Brochure
2018
- (FDA, 2018) ⇒ U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) (2018). [Chapter 7: Investigator's Brochure]. In: E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry.
- QUOTE: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. The information should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that generated the described data.