Clinical Trial Investigator's Brochure

The Investigator's Brochure or IB is a compilation of the clinical and nonclinical data on the investigational product that is relevant to the study of the product in human subjects.

GCP Guidelines

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GCP guidelines state that the purpose of the IB is to provide the investigators and others involved in the trial with the information to improve their understanding and compliance with of the protocol, especially regarding:

• The dose
• The dose frequency/interval
• Methods of administration
• Safety monitoring procedures

Regulatory Requirements

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Regulations require that at a minimum, the IB should include:

• Description of drug substance
• Information from previous experience with the drug
• Pharmacological and toxicological effects
• Summary of pharmacokinetics
• Safety and effectiveness
• Risks and Side Effects

IThe IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial.

Presentation of Information in Investigator's Brochure

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The information in the IB should be:

• Concise
• Simple
• Objective
• Balanced
• Non-promotional

Information included in the IB should be such that a clinician or potential investigator can understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial.

Who should edit the Investigator's Brochure?

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A medically qualified person should edit an IB, but the contents of the IB should be approved by the disciplines that generated the described data.

ComplianceOnline training on Good Clinical Practices

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Clinical Trials and Good Clinical Practice

This Clinical Trials and GCP session describes the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.

The Importance of ICH Guidelines and its Role in Achieving Good Clinical Practice

This presentation reviews the key concepts of GCP and correlates them to the ICH guidelines.

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

This Clinical Trial training provides a detailed review of the FDA regulations for Clinical Trials Process.