2025年的GCP：透明度革命

ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICEE6(R3) Final versionAdopted on06January2025 This Guideline has been developed by the appropriate ICH Expert Working Group and has beensubject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4of the Process thefinal draft is recommended for adoption to the regulatory bodies of ICH regions. Legal notice:This document is protected by copyright and may, with the exception of the ICH logo, beused, reproduced, incorporated into other works, adapted, modified, translated or distributed under apublic license provided that ICH's copyright in the document is acknowledged at all times. In case ofany adaption, modification or translation of the document, reasonable steps must be taken to clearlylabel, demarcate or otherwise identify that changes were made to or based on the original document.Any impression thatthe adaption, modification or translation of the original document is endorsed orsponsored by the ICH must be avoided.The document is provided "as is" without warranty of any kind.In no event shall the ICH or the authors of the original document be liable for any claim, damages orother liability arising from the use of the document.The above-mentioned permissions do not apply tocontent supplied by third parties. Therefore, for documents where the copyright vests in a third party,permission for reproduction must be obtained from this copyright holder. ICHE6(R3)Guideline ICHHARMONISEDGUIDELINE GUIDELINE FORGOODCLINICALPRACTICE E6(R3) ICH Consensus Guideline iTABLE OF CONTENTSI.INTRODUCTION........................................................................................................1Guideline Scope.........................................................................................................................1Guideline Structure....................................................................................................................1II.PRINCIPLES OF ICH GCP.......................................................................................2III.ANNEX 1......................................................................................................................71.INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICSCOMMITTEE (IRB/IEC)...........................................................................................71.1Submission and Communication...................................................................................81.2Responsibilities..............................................................................................................81.3Composition, Functions and Operations........................................................................91.4Procedures....................................................................................................................101.5Records........................................................................................................................112.INVESTIGATOR......................................................................................................112.1Qualifications and Training.........................................................................................112.2Resources.....................................................................................................................122.3Responsibilities............................................................................................................122.4Communication with IRB/IEC....................................................................................122.5Compliance with Protocol............................................................................................132.6Premature Termination or Suspension of a Trial.........................................................142.7Participant Medical Care and Safety Reporting...........................................................142.7.1Medical Care of Trial Participants...........................................................142.7.2Safety Reporting........................................................................................142.8Informed Consent of Trial Participants........................................................................152.9End of Participation in a Clinical Trial........................................................................192.10Investigational Product Management..........................................................................202.11Randomisation Procedures and Unblinding.................................................................212.12Records........................................................................................................................21 ICHE6(R3)Guideline 2.13Reports.........................................................................................................................233.SPONSOR....................................................................