Investigator’s brochure

As a first step, the sponsor is required to prepare an investigator s brochure (IB). This must be an objective compilation of available clinical and non-clinical data on the... 

Table 5.3 Suggested headings for an Investigator s Brochure according to ICH guidelines.

The investigator s brochure, the case report forms, the confirmation of insurance of subjects and the documents used to obtain informed consent... 

Investigator s Brochure, in Investigational New Drug Applications, 25 691 Investigator information, for Investigational New Drug Applications, 25 690 Investment... 

GCP Addendum on investigator s brochure GCP Addendum on essential documents for the conduct of a clinical trial... 

Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator s brochure for an unapproved investigational medicinal product). 

Results of previous related research (i.e., investigator s brochure)... 

A normal course of event in initiating a clinical trial is for the Sponsor (see below) to prepare an Investigator s Brochure and select an Investigator to conduct the trial. The Sponsor and Investigator then prepare the trial protocol. 

Investigator Investigator s Brochure Informed consent Protocol... 

Clinical Trial Protocol and Protocol Amendments Investigator s Brochure... 

The Investigator s Brochure is a collection of information prepared and updated by the Sponsor for the Investigator. The information consists of all the data relevant to the drug under investigation, including properties of the drug, the PK and PD, and toxicity results on animals (Exhibit 6.8). 

Items 1-3 and 9 and 10 are self-explanatory and will not be discussed further. Items 4-6, and 9 on Investigational Plan, Investigator s Brochure, and Protocols and human experience are covered in Chapter 6, and Pharmacology and Toxicity data are discussed in Chapter 5. We will concentrate our discussion on Item 7. 

Clinical Practice Section 7.3 Content of the Investigator s Brochure. London EMEA, 1996. 

Receipt of investigator s brochure (letters should clearly indicate what documents were received and when)... 

There should be consistency between the possible adverse events described for the study drug in the protocol, investigator s brochure and ICF. Most coimtries have specific requirements for their ICF. It is essential that the requirements are known when the country-specific ICF is prepared. These examples could easily have changed by the time the reader is checking an ICF. In the United Kingdom, reference should be made to the ABPI (Association of the British Pharmaceutical Industry) Clinical Trial Compensation Guidelines. In other countries, for example, Ireland, the study subject is allowed a specific length of time to decide whether to enter the study. 

The investigator s brochure provides more detail than the protocol in relation to the background of the study, and should help to facilitate a better understanding of the rationale for the protocol and its key features. In an ideal world, the potential investigator will receive the investigator s brochure before deciding to participate in the study. The brochure should provide the investigator with sufficient information to decide if the... 

Document (may be in protocol or investigator s brochure) with full details of study drug including details of stabihty, method of destruction, etc. 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

Under the CTN scheme the sponsor of the clinical trial provides detailed information about the proposed trial to the principal investigator who submits an application to conduct the clinical trial to the HREC at the institution or other site at which the trial is proposed to be conducted. The clinical trial application generally includes the protocol, the investigator s brochure, related patient information, supporting data and the CTN form. HRECs usually have their own standard format for applications to conduct a CTN trial at their institution. The HREC evaluates the scientific and ethical validity of the proposed clinical trial and the safety and efficacy of the medicine in the context of its stage of development. The TGA does not evaluate any information about the clinical trial. 

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