It is critical to have access to a properly designed Investigator’s Brochure Template in order to be compliant with ICH Topic E 6 (R1) “Guideline for Good Clinical Practice.” To provide a basic definition, an investigator’s brochure (IB) is one of the most important documents used in clinical trials and serves as a label for the product until the results are clear enough to produce a label. In other words, it provides detailed background and rationale for the investigational medicinal product as well as its current status in terms of the stage of trials, safety, and efficacy to investigators, FDA personnel, IRB members, and investors.
IB needs to be updated at least once a year and more if there are updates and is often one of the common FDA’s areas of concern during a review and need to realistically reflect the benefits and risks of the investigational medicinal product.
This is an MS Word template of an Investigator’s Brochure Template to be used as a starting point for drafting an Investigator’s Brochure to be provided to the investigators.
Please note that in this Investigator’s Brochure Template
- The blank text place holders enclosed “<Enter Text>” indicates where specific detail is to be inserted (replace as appropriate).
- Ensure that you replace all placeholders with project-specific information.
- Please review this template and feel free to adapt it to your specific needs.
- Leave the template version information in the form and update it according to after each update.
Using this Investigator’s Brochure Template and the instructions provided will assist you to:
- Identify the essential components of an IB
- Identify the information that you want to include in IB
- Become familiar with best practices for formatting, writing styles, flow, and presentation of an IB
- Use authoring notes throughout the template based on ICH Topic E 6 (R1) “Guideline for Good Clinical Practice.”
Who Can Benefit From This Course
The template will assist the following in the preparation of audits for GLP compliance:
- Clinical research scientists
- Clinical project managers
- Medical writers / Regulatory writers
- Regulatory affairs personnel
- Quality assurance personnel
- Medical affairs personnel
- Vice presidents, Directors, and Managers
- Investors interested in investing in FDA-regulated industry
- ID: 1883
- SKU: TE-0004-RC
- Type: Template
- Format: Template File (.doc)
- Date of Last Update: Mar 01, 2018
- Price: $200.00
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