The Investigator’s Brochure(IB)
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1. Introduction of the Investigator’s Brochure
- The Investigator’s Brochure is a document that consists of the clinical and non-clinical data relevant to the study of the medical device.
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2. Purpose of the Investigator’s Brochure (IB)
- The main purpose of the IB is to provide investigators, clinicians and other experts who are involved in the process of the clinical investigation, with necessary information such as dose, dose frequency, visiting interval, method of administration, safety monitoring procedures etc. The information according to the GCP (Good Clinical Practice) should be presented in ‘a concise, simple, objective, balanced and non-promotional form’.
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3. Who prepare and Who assess?
- Investigator’s Brochures should be prepared by the sponsor. A medically qualified person should also participate in editing of the IB, but the final approval of the content of IB should be made by researched who generated the data. The IB should be reviewed and revised annually, more frequent revision of the IB data may be appropriate in case of the generation of relevant new information regarding the medicine or medical device.
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The information IB should include :
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General
① Introduction
② Identification of the IB
③ Sponsor/Manufacturer
- Investigational device information
- Preclinical Testing
- Existing Clinical Data
- Risk Management
- Regulatory and other references
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General
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