Investigator’s brochure – a document containing a summary of current data on a chemical substance or preparation that is a potential new drug or a drug with a potential new indication to be further evaluated in a new clinical trial.
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The investigator’s brochure shall contain data on clinical and pre-clinical trials of the investigational medicinal product relevant to the conduct of the clinical trial. The information contained in the investigator’s brochure should be presented in a concise, understandable and objective way, not intended to promote the IMP, so as to make it possible to assess the benefit-risk balance and the appropriateness of the clinical trial assumptions. leaflets printing
Documentation of the clinical trial
The investigator’s brochure should be produced at the clinical trial planning stage and should be documented in the investigator’s documentation prior to formal initiation, together with a document of receipt signed and dated by each investigator to confirm that up-to-date scientific information on the investigational product has been submitted to the investigator. During the clinical trial phase, updates of the investigator’s brochure shall be issued, as necessary and as new information becomes available, and shall be included in the study file together with a document of receipt signed and dated by each investigator to confirm that all new information has been submitted to the investigator in due time.
The investigator’s brochure should be included in the files of the sponsor and the investigator.
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Content. According to the ICH-GCP guidelines, the investigator’s brochure should contain the following elements:
Title page – name, surname and address or name and registered office of the sponsor, name and description of the investigational medicinal product (trial number, chemical name or trade name, if legally acceptable and expected by the sponsor) and date of publication of the brochure, it is also recommended to include the issue number and a reference to the number and date of publication replaced by the current edition.