Investigator Brochure

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not funded x Federal State industry foundation UNC-CH
not funded x Federal State industry foundation UNC-CH
Not funded x federal state industry foundation unc-ch other (specify): epa intramural federal research for industry sponsored research (if applicable): sponsor’s master protocol version #: version date: investigator brochure version #: version...
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What is Investigator Brochure?

An Investigator Brochure is a document that provides essential information about a pharmaceutical product or medical device to investigators conducting clinical trials. It contains comprehensive details about the product's composition, formulation, pharmacokinetic properties, and safety profile. The Investigator Brochure serves as a valuable resource for investigators to understand and evaluate the investigational product.

What are the types of Investigator Brochure?

There are primarily two types of Investigator Brochures: Investigator's Brochure for an Investigational New Drug (IND) and Investigator's Brochure for an Approved Drug. The IND Investigator's Brochure contains information about new drugs that have not yet been approved by regulatory authorities. On the other hand, the Investigator's Brochure for an Approved Drug provides updated information about a drug that has already received regulatory approval.

IND Investigator's Brochure
Investigator's Brochure for an Approved Drug

How to complete Investigator Brochure

Completing an Investigator Brochure requires meticulous attention to detail. Here are the key steps to follow:

01
Gather all relevant information about the investigational product, including its composition, manufacturing process, and clinical trial data.
02
Organize the information in a clear and concise manner, ensuring that it is easily accessible to investigators.
03
Include comprehensive safety and efficacy data, as well as any adverse effects observed during the clinical trials.
04
Review and update the Investigator Brochure regularly to incorporate new findings and updates.
05
Ensure that the Investigator Brochure complies with regulatory requirements and guidelines.
06
Provide a summary of the Investigator Brochure to investigators before they begin the clinical trial.

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Questions & answers

Introduction: A thorough discussion of the known effects of the investigational product(s) in humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics, dose response, safety, efficacy, and other pharmacological activities.
The Investigator's Brochure (IB) is a comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device or other product) maintained by a drug developer or investigator that contains the body of information about the investigational product obtained before and during a
Investigator's Brochure (IB) is a document which contains all the available clinical and non-clinical data on the Investigational Product(s) that are known and relevant to the study of the product.
The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other trials. An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.
What is Reference Safety Information? Reference Safety Information (RSI) defines which reactions are expected for the Investigational Medicinal Product (IMP) being administered to subjects participating in a clinical trial.
A complete and thorough Investigator's Brochure should include the following: 7.2. 1 Title Page. 7.2. 2 Confidentiality Statement. 7.3 Contents of the Investigator's Brochure. 7.3.1 Table of Contents. 7.3. 2 Summary. 7.3. 3 Introduction. 7.3. 4 Physical, Chemical and Pharmaceutical Properties and Formulation. 7.3.
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