What should investigator brochure include?

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 …

Are investigator brochures confidential?

A statement which reminds Investigators and other recipients to treat the Investigator’s Brochure as a confidential document and an important resource for the Investigators team and the Institutional Review Boards (IRBs) and Independent Ethics Committee (IEC).

How long should an investigator’s brochure be?

As for most documents, a concise and focused presentation style will have the best chances of communicating the necessary messages to the intended audience. In practice, an IB should not need to exceed ∼100 pages, and a shorter document can also be sufficient.

What are investigators responsibilities?

– An investigator is responsible for: Maintaining adequate records of the disposition of the drug. Accurate case histories that record all observations, and. Other data pertinent to the investigation on each individual. administered the investigational drug or employed as a control in.

What is investigational brochure in clinical trials?

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.

Does the FDA approve investigator brochures?

For studies conducted under an investigational new drug application, an investigator’s brochure is usually required by FDA. Even though 21 CFR part 56 does not mention the investigator’s brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB.

What are the qualities of a good investigator?

7 Qualities Found in a Successful Professional Investigator

  • Professionalism. This is a quality required for any career stream.
  • Integrity. One of the most important virtues of a professional investigator is integrity.
  • Persistence.
  • Self-driven.
  • Problem Solver.
  • Reliable.
  • Courage.

What is an investigator protocol?

Investigation protocols are a set of standard statements that publicly explain the process and expectations that guide the process. Once they’re put in place, they exert tremendous power in making sure that the outcome of your investigation will be valid, transparent and legally defensible.

What is an investigator’s brochure?

INVESTIGATOR’S BROCHURE The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product (s) that are relevant to the study of the product (s) in human subjects.

What is Investigator’s Brochure-ICH GCP 7?

INVESTIGATOR’S BROCHURE – ICH GCP 7. INVESTIGATOR’S BROCHURE The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product (s) that are relevant to the study of the product (s) in human subjects.

What is the best way to provide product information to investigators?

Where permitted by regulatory authorities, a basic product information brochure, package leaflet, or labelling may be an appropriate alternative, provided that it includes current, comprehensive, and detailed information on all aspects of the investigational product that might be of importance to the investigator.

Can a sponsor-investigator provide an expanded background information section?

In cases where preparation of a formal IB is impractical, the sponsor-investigator should provide, as a substitute, an expanded background information section in the trial protocol that contains the minimum current information described in this guideline. 7.2 General Considerations The IB should include: