What does an 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 …
How do you make an investigator brochure?
A brief introductory statement should be provided that contains the chemical name (and generic and trade name(s) when approved) of the investigational product(s), all active ingredients, the investigational product (s ) pharmacological class and its expected position within this class (e.g. advantages), the rationale …
Does the IRB review investigator brochure?
To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
What makes up an Investigator’s Brochure ( IB )?
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 should be included in an Ich gcp-7 brochure?
7.2 General Considerations The IB should include: This should provide the sponsor’s name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name (s) where legally permissible and desired by the sponsor), and the release date.
What is an investigator’s brochure in drug development?
In drug development, the Investigator’s Brochure (IB) summarises the main elements of the entire development programme to date, primarily for the benefit of investigators conducting clinical studies.
Do you need brochure for investigator sponsored trial?
In the case of an investigator sponsored trial, the sponsor-investigator should determine whether a brochure is available from the commercial manufacturer. If the investigational product is provided by the sponsor-investigator, then he or she should provide the necessary information to the trial personnel.