If the investigational product is provided by the sponsor-investigator, then he or she should provide the necessary information to the trial personnel. Such a summary should incorporate studies that assess potential therapeutic activity (e.g. advantages), the rationale for performing research with the investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s).
Where appropriate, the published reports on related products should be discussed. 0000001216 00000 n 0000013480 00000 n 0000035060 00000 n 0000010548 00000 n An example is given in Appendix 1.The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document for the sole information and use of the investigator's team and the IRB/IEC.The IB should contain the following sections, each with literature references where appropriate:An example of the Table of Contents is given in Appendix 2A brief summary (preferably not exceeding two pages) should be given, highlighting the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the stage of clinical development of the investigational product.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. 0000009417 00000 n endstream endobj 44 0 obj<> endobj 45 0 obj<> endobj 46 0 obj<> endobj 47 0 obj<>/Border[0 0 0]/Type/Annot>> endobj 48 0 obj< Any structural similarities to other known compounds should be mentioned.The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form.

Instructions for the storage and handling of the dosage form(s) should also be given. If a marketed product is being studied for a new use (i.e., a new indication), an IB specific to that new use should be prepared. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL. In this way, the investigator can be provided with the most informative interpretation of the available data and with an assessment of the implications of the information for future clinical trials.

0000016769 00000 n 0000001973 00000 n
0000035334 00000 n 0000004796 00000 n In cases where a number of clinical trials have been completed, the use of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear presentation of the data. This document addresses the good clinical practice, ... Ethics Committee, Institutional Review Board, investigator, sponsor, protocol, investigator's brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report. 0000002434 00000 n

In cases where preparation of a formal IB is impractical, the sponsor-investigator should provide, as a substitute, an expanded background information section in the trial protocol that contains the minimum current information described in this guideline.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. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. 88 0 obj<>stream Conditions: Discontinuation of Pain Medication; Pain, Chronic It is expected that the type and extent of information available will vary with the stage of development of the investigational product. %PDF-1.4 %���� The IB should be reviewed at least annually and revised as necessary in compliance with a sponsor’s written procedures.

0000004122 00000 n Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such … 43 46 0000014100 00000 n

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0000012437 00000 n 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. 0000002818 00000 n Where possible, a summary of each completed clinical trial should be provided. 0000034628 00000 n 0000004408 00000 n 0000007219 00000 n 0000010385 00000 n 0000012279 00000 n In the case of an investigator sponsored trial, the sponsor-investigator should determine whether a brochure is available from the commercial manufacturer.

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