In drug development and medical device development[1] 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".[2]
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.
As part of its guidance on good clinical practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US).[1] (broken link)
If many clinical trials have been completed, tables that summarize findings across the various studies can be very useful to demonstrate outcomes in, e.g., different patient populations or different indications.
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application [2]
Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) [3]
CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. [4]
CDER Guidance for Industry. Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. [5]
CDER Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. [6]
^Doerr, Beatrix; Whitman, Sophia; Walker, Steven. "Writing for medical devices compared to pharmaceuticals: An introduction" (PDF). EMWA. p. 6. Retrieved 30 March 2021.
International Conference on Harmonisation (ICH) Topic E6-Guideline for Good Clinical Practice [7]
May 04, 2023
investigator, brochure, this, article, needs, additional, citations, verification, please, help, improve, this, article, adding, citations, reliable, sources, unsourced, material, challenged, removed, find, sources, news, newspapers, books, scholar, jstor, sep. This article needs additional citations for verification Please help improve this article by adding citations to reliable sources Unsourced material may be challenged and removed Find sources Investigator s brochure news newspapers books scholar JSTOR September 2009 Learn how and when to remove this template message In drug development and medical device development 1 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 proceduresAn 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 2 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 3 Guidance documents EditAs part of its guidance on good clinical practice GCP the International Conference on Harmonisation ICH has prepared a detailed guidance for the contents of the IB in the European Union EU Japan and the United States US 1 broken link If many clinical trials have been completed tables that summarize findings across the various studies can be very useful to demonstrate outcomes in e g different patient populations or different indications Code of Federal Regulations Title 21 Part 312 Investigational New Drug Application 2 Code of Federal Regulations Title 21 Part 201 56 and Part 201 57 3 CDER Guidance for Industry Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products Content and Format 4 CDER Guidance for Industry Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products Content and Format 5 CDER Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers 6 See also EditDirective 2001 20 EC Europe Directive 2005 28 EC Europe Clinical trialReferences Edit Doerr Beatrix Whitman Sophia Walker Steven Writing for medical devices compared to pharmaceuticals An introduction PDF EMWA p 6 Retrieved 30 March 2021 ICH GCP guidelines PDF Archived copy PDF Food and Drug Administration Archived from the original PDF on 2018 02 25 Retrieved 2019 12 16 a href Template Cite web html title Template Cite web cite web a CS1 maint archived copy as title link International Conference on Harmonisation ICH Topic E6 Guideline for Good Clinical Practice 7 Retrieved from https en wikipedia org w index php title Investigator 27s brochure amp oldid 1106171577, wikipedia, wiki, book, books, library,
