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Investigator's Brochure Guidance

Investigator's Brochure Guidance - 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 drug trial. Investigator’s brochure.58 a.1 introduction.58 a.2 general considerations.59 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. What is the purpose of an ib? Content of the investigator’s brochure. According to the eu requirements for good clinical practice in clinical trials (note for guidance on good clinical practice (cpmp/ich/135/95), the information in an investigator brochure (ib) should be: Chapter 7 of the good clinical practice guideline (chmp/ich135/95) describes the requirements for an ib. Good clinical practice (gcp) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to 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.

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