DocumentationGlossary Term
ICH E6(R3) Section 1.43
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.
A protocol amendment represents the formal mechanism for modifying an approved clinical trial protocol. Unlike protocol deviations, which are unplanned departures from protocol requirements, amendments are prospective changes that undergo proper review and approval before being implemented. The amendment process ensures that proposed modifications are scientifically justified, do not compromise participant safety, and maintain the integrity of the trial.
Protocol amendments may be necessary for various reasons throughout a trial's duration. New scientific information may require changes to inclusion criteria, dosing regimens, or safety monitoring procedures. Emerging safety signals may necessitate additional assessments or modified eligibility requirements. Operational challenges may require adjustments to visit schedules or sample collection procedures. Regulatory authority feedback may require protocol clarifications or modifications. Regardless of the reason, all amendments must be properly justified and documented.
The amendment approval process typically involves sequential review by the sponsor, IRB/IEC, and regulatory authorities where required. The sponsor initiates amendments and must ensure that they are scientifically appropriate and adequately documented. The IRB/IEC reviews amendments to confirm that the changes do not adversely affect the rights and welfare of participants. Regulatory authorities review amendments to ensure continued compliance with applicable requirements. Implementation cannot occur until all required approvals are obtained, and sites must be formally notified and trained on new requirements.
Safety-driven amendment
"Following reports of hepatic enzyme elevations, the sponsor developed an amendment requiring more frequent liver function testing and established new discontinuation criteria for hepatotoxicity."
Enrollment criteria change
"To improve enrollment rates, the sponsor submitted an amendment widening the age range for eligibility from 18-65 years to 18-75 years, with additional safety monitoring for participants over 65."
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 compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects.
A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
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 1.43
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.
A protocol amendment represents the formal mechanism for modifying an approved clinical trial protocol. Unlike protocol deviations, which are unplanned departures from protocol requirements, amendments are prospective changes that undergo proper review and approval before being implemented. The amendment process ensures that proposed modifications are scientifically justified, do not compromise participant safety, and maintain the integrity of the trial.
Protocol amendments may be necessary for various reasons throughout a trial's duration. New scientific information may require changes to inclusion criteria, dosing regimens, or safety monitoring procedures. Emerging safety signals may necessitate additional assessments or modified eligibility requirements. Operational challenges may require adjustments to visit schedules or sample collection procedures. Regulatory authority feedback may require protocol clarifications or modifications. Regardless of the reason, all amendments must be properly justified and documented.
The amendment approval process typically involves sequential review by the sponsor, IRB/IEC, and regulatory authorities where required. The sponsor initiates amendments and must ensure that they are scientifically appropriate and adequately documented. The IRB/IEC reviews amendments to confirm that the changes do not adversely affect the rights and welfare of participants. Regulatory authorities review amendments to ensure continued compliance with applicable requirements. Implementation cannot occur until all required approvals are obtained, and sites must be formally notified and trained on new requirements.
Safety-driven amendment
"Following reports of hepatic enzyme elevations, the sponsor developed an amendment requiring more frequent liver function testing and established new discontinuation criteria for hepatotoxicity."
Enrollment criteria change
"To improve enrollment rates, the sponsor submitted an amendment widening the age range for eligibility from 18-65 years to 18-75 years, with additional safety monitoring for participants over 65."
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 compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects.
A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
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.