DocumentationGlossary Term
ICH E6(R3) Section 1.36
A compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects.
The Investigator's Brochure serves as the comprehensive reference document providing investigators with essential information about the investigational product under study. This compilation includes available physical, chemical, pharmaceutical, and biological data; preclinical pharmacology, toxicology, pharmacokinetic, and metabolic information; and all available clinical data including pharmacology, efficacy, and safety information from previous human studies. The IB enables investigators to understand the rationale for the trial and to make informed decisions about participant care.
The IB must contain sufficient information to support the proposed clinical investigation and to provide investigators with the information they need to conduct the trial safely and in accordance with the protocol. Key sections include a summary of the product's characteristics, physical and chemical properties, nonclinical study summaries, effects in humans from any prior clinical experience, guidance for investigators on recognizing and managing potential adverse reactions, and references to published literature.
Sponsors are responsible for keeping the IB current throughout the development program. As new information becomes available from ongoing studies, the IB must be reviewed and updated at least annually, though more frequent updates may be necessary when significant new safety or efficacy information emerges. Updated IBs must be provided to investigators and to IRBs/IECs, and new information may trigger the need for protocol amendments or updated informed consent processes to ensure that participants are aware of relevant new findings.
Study initiation
"Before signing the investigator agreement, Dr. Martinez thoroughly reviewed the Investigator's Brochure to understand the drug's mechanism of action, prior clinical experience, and potential adverse effects."
Safety assessment
"When evaluating a participant's new symptom, the investigator consulted the IB to determine whether the symptom was consistent with the known safety profile of the investigational product."
A printed, optical, or electronic document designed to record all protocol-required information on each trial subject.
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
A written description of a change or formal clarification to a protocol that must be approved by the sponsor, IRB/IEC, and regulatory authorities before implementation.
Original documents, data, and records from which a subject's clinical trial data are obtained, including hospital records, clinical and office charts, laboratory notes, memoranda, pharmacy records, and patient diaries.
ICH E6(R3) Section 1.36
A compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects.
The Investigator's Brochure serves as the comprehensive reference document providing investigators with essential information about the investigational product under study. This compilation includes available physical, chemical, pharmaceutical, and biological data; preclinical pharmacology, toxicology, pharmacokinetic, and metabolic information; and all available clinical data including pharmacology, efficacy, and safety information from previous human studies. The IB enables investigators to understand the rationale for the trial and to make informed decisions about participant care.
The IB must contain sufficient information to support the proposed clinical investigation and to provide investigators with the information they need to conduct the trial safely and in accordance with the protocol. Key sections include a summary of the product's characteristics, physical and chemical properties, nonclinical study summaries, effects in humans from any prior clinical experience, guidance for investigators on recognizing and managing potential adverse reactions, and references to published literature.
Sponsors are responsible for keeping the IB current throughout the development program. As new information becomes available from ongoing studies, the IB must be reviewed and updated at least annually, though more frequent updates may be necessary when significant new safety or efficacy information emerges. Updated IBs must be provided to investigators and to IRBs/IECs, and new information may trigger the need for protocol amendments or updated informed consent processes to ensure that participants are aware of relevant new findings.
Study initiation
"Before signing the investigator agreement, Dr. Martinez thoroughly reviewed the Investigator's Brochure to understand the drug's mechanism of action, prior clinical experience, and potential adverse effects."
Safety assessment
"When evaluating a participant's new symptom, the investigator consulted the IB to determine whether the symptom was consistent with the known safety profile of the investigational product."
A printed, optical, or electronic document designed to record all protocol-required information on each trial subject.
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
A written description of a change or formal clarification to a protocol that must be approved by the sponsor, IRB/IEC, and regulatory authorities before implementation.
Original documents, data, and records from which a subject's clinical trial data are obtained, including hospital records, clinical and office charts, laboratory notes, memoranda, pharmacy records, and patient diaries.