It is critical to have access to a properly designed Investigator’s Brochure Template to comply with ICH Topic E 6 (R1) “Guideline for Good Clinical Practice.” An investigator’s brochure (IB) is one of the most important documents used in clinical trials to provide a basic definition. Generally, it serves as a label for the product until the results are clear enough to produce a label. Basically, it provides detailed background and rationale for the investigational medicinal product and 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. Often, it is one of the common FDA’s areas of concern during a review and needs to realistically reflect the benefits and risks of the investigational medicinal product.
This is an MS Word template of an Investigator’s Brochure Template that you can use 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 placeholders 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 accordingly 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 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” (GLP).
Who Can Benefit From This Course
The template will assist the following in the preparation of audits for GLP compliance:
- Clinical research scientists
- Project managers
- Clinical Trial experts
- 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: 1890
- SKU: TE-0005-RC
- Type: Template
- Format: Template File (.docx)
- Date of Last Update: Mar 01, 2018
- Price: $200.00
- Upon Check out, check your basket to ensure you have the right product(s) for your needs.
- Fill out the billing information and enter a Coupon Code if you have one.
- Press “Proceed to PayPal” to pay for your selected product(s) in your basket.
- We will direct you to PayPal for payment, where you can pay with a credit card (Visa, Master Card, American Express, and Discover) or debit card (You do not need a PayPal account).
- After purchase, we will redirect you back to the website.
- We will send you the link to download the PDF version of the document by e-mail upon completing registration and payment.
- Please provide feedback on your purchasing experience from us (Easy Global Training) so that we may constantly improve our products and services.
Feel free to browse our collaborator’s site (Neometrix Consulting Inc.).