FDA Rules for the Content, Tone and Format of an Investigator’s Brochure

by Dr. Mukesh Kumar | May 13, 2020

Investigator’s Brochure (IB)

Investigator’s Brochure template is provided to attendees.

An Investigator’s Brochure (IB) is perhaps one of the most important documents used in clinical trials after the clinical protocol. The IB provides the detailed background of the investigational product to the doctors participating in the trial and gives talking points to discuss with the subjects and IRBs. It is required to update the IB every year at the time of annual reports to the FDA even if no other documents used in the study were revised. An IB not only provides a precise summary of the available information but is also expected to build the rationale for the study and educate the study teams about the overall context of the clinical trial and of the overall development program. IB is also one of the most common areas of concern during FDA review. FDA frequently sites sponsors for improperly written IB that claims benefits and superiority for the investigational products while underplaying the risks.

Why should you attend:

This webinar, presented by a leading industry expert who authored more than 50 Investigator’s Brochures, will discuss FDA expectations from IBs, writing styles, common errors, and review findings. The seminar will list the different areas of IB with tips for what kind of information to include and avoid in an IB. Writing tips for style, tone, citations, and presenting contextual information for an appropriate balance of encouraging information for an investigational product without creating undue hype for it will be discussed. The presenter will use case studies and examples to highlight how one can present all information in a precise, supportive and FDA-acceptable manner while maintain high level of appeal for the product in the eyes of the investigators and study teams. Dos and don’ts, common areas of concern, and potential solutions will be discussed. Best practices for formatting, reviewing, finalizing, revising, and training personnel will be presented. This seminar is a must for new clinical trial professionals and a good update for the experienced ones to understand the current regulatory requirements for IB.

Areas Covered in the Session:

  • Essential components of an Investigator’s Brochure
  • Components of SOP and other regulatory processes for IBs
  • What information to include or avoid in an IB (Investigator’s Brochure Content)
  • Best practices for style, tone, formatting, and presentation of IBs
  • Ways for balancing positive, negative and neutral information in an IB
  • Common FDA findings of unacceptable IB statements

Who will benefit:

  • Clinical research associates
  • Clinical project managers
  • Medical writers
  • Sponsors
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He has been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the US FDA, EMA, and regulators in more than 40 countries.

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