Clinical investigators brochure

Prior to the initiation of initial studies in humans, it is important that all of the nonclinical information available is made into an integrated summary. This information must be included in the clinical investigators brochure so that the clinical protocol can be modified to include relevant biochemical or other markers to minimize human risk. The regulatory authority and ethics committees are... 

The structure of an IND application is contained in the regulation and is quite easily followed. Almost all pharmaceutical companies, contract research organizations and universities have templates for the writing of these documents. All the animal data, the proposed clinical study protocol, a clinical investigators brochure and the chemistry and manufacturing controls must be described. 

The Medical Information department may have its own medical writers dedicated to phase IV (postapproval) publications, booklets and pamphlets. Many large companies have a specific Medical Writing department usually reporting into the Research department, who will assist in writing clinical reports, publications and help prepare the clinical investigational brochure or NDA annual safety reports. These associates usually have science degrees and have been trained in technical and medical writing. 

All these observations and findings will be included in the Clinical Investigators Brochure (CIB). Indeed, the initial guidance for clinical hazard potential may depend almost entirely on safety pharmacology findings because of an unspectacular toxicology profile, the lack of human exposure, and the fact that normal volunteers are unlikely to be capable of exhibiting certain adverse event types... 

Institutional review board records that do not adequately track or log research documents that have been submitted by the clinical investigator, including protocols, amendments, consent forms, Investigator Brochures, IND safety reports, advertisements, patient information sheets, and correspondence between the investigator and the IRB. 

Be thoroughly familiar with the properties of the clinical study medications/devices as described in the investigator brochure... 

S. A. Mahler, Review of Clinical Studies of Exp. 126, Investigational Brochure, E. I. DuPont de Nemours and Company (I966). 

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