When Is An Investigator Brochure Not Required

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What is when is an investigator brochure not required?

A when an investigator brochure is not required when there is already an existing comprehensive report or document that contains all the necessary information about the investigational product. This report or document should cover aspects such as the pharmacokinetics, pharmacodynamics, and toxicology of the product.

What are the types of when is an investigator brochure not required?

There are two types of situations when an investigator brochure is not required. The first type is when the investigational product is already approved for another indication, and the second type is when the investigational product is a new formulation of an already approved product.

Existing comprehensive report or document covering all necessary information

Investigational product approved for another indication

New formulation of an already approved product

How to complete when is an investigator brochure not required

To complete when an investigator brochure is not required, you need to ensure that all the necessary information about the investigational product is already available in the existing comprehensive report or document. Additionally, you should clearly state the type of situation that exempts the need for an investigator brochure.

Gather all relevant information about the investigational product

Ensure the information is comprehensive and covers all necessary aspects

Clearly state the type of situation exempting the need for an investigator brochure

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Questions & answers

When should an investigator brochure be updated?

The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.

What are the essential documents?

Essential documents are those documents that individually and collectively allow the evaluation of the conduct of a trial and the quality of the data generated.

How long should the sponsor and investigator retain essential documents?

Sponsor and Investigator must retain records for 2 years after marketing or 2 years after investigational use is discontinued and FDA notified. Also see VCU's record retention policy.

What should be included in an investigator brochure?

The Investigator's Brochure should identify countries where the investigational product has been approved and marketed. Any important information arising from the marketed use should be summarised (e.g. formulations, dosages, routes of administration, and adverse product reactions).

Is investigator brochure part of IND?

Clinical Protocols and Investigator Brochures: A detailed clinical study protocol, and Investigator Brochure are required sections of an IND application.

What documents are required only for investigator files?

The essential documents that should be included in the ISF include: Trial Protocol. Participant Information Sheet and Consent Forms. Investigator Brochure. Regulatory documents, applications and approvals. Delegation Logs. Safety Reports. Correspondence between delegated site staff and Sponsor.