Document:ICH ICH E6 Guideline R3 (2025)
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| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| ICH ICH E6 Guideline R3 (2025) Appendix A | G | Appendix A | EN | Appendix A. INVESTIGATOR’S BROCHURE… |
| ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 | G | Appendix A 3.4 | EN | A.3 Contents of the Investigator’s Brochure
[...] A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation A description should be prov… |
| ICH ICH E6 Guideline R3 (2025) Appendix B | G | Appendix B | EN | Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) Clinical trials should be described in a clear, concise and operationally feasible proto… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 | G | Appendix B 12.3 | EN | Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
[...] B.12.3 Description of the process for the handling of non-compliance with the prot… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 14.3 | G | Appendix B 14.3 | EN | Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
[...] B.14 Data Handling and Record Keeping [...] B.14.3 A statement that records shoul… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 16 | G | Appendix B 16 | EN | B.16 Publication Policy Publication policy, if not addressed in a separate agreement.… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 | G | Appendix B 2.5 | EN | Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
[...] B.2.5 A statement that the trial will be conducted in compliance with the protocol… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 | G | Appendix B 4.8 | EN | B.4 Trial Design
[…] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 | G | Appendix B 4.8 | EN | B.4 Trial Design
[…] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for indivi… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 5 | G | Appendix B 5 | EN | B.5 Selection of Participants
B.5.1 Participant inclusion criteria. B.5.2 Participant exclusion criteria. B.5.3 Mechanism for pre-screening, where … |
| ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 | G | Appendix B 6 | EN | B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the tr… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 | G | Appendix B 6 | EN | B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the tr… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 8 | G | Appendix B 8 | EN | Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
[...] B.8 Assessment of Efficacy B.8.1 Specification of the efficacy parameters, where a… |
| ICH ICH E6 Guideline R3 (2025) Appendix B 9.4 | G | Appendix B 9.4 | EN | B.9.4 The type and duration of the follow-up of participants after adverse events and other events such as pregnancies.… |
| ICH ICH E6 Guideline R3 (2025) Appendix B. B4 | G | Appendix B. B4 | EN | B.4 Trial Design The scientific integrity of the trial and the reliability of the results from the trial substantially depend on the trial design. A d… |
| ICH ICH E6 Guideline R3 (2025) Appendix C-002 | G | Appendix C | EN | Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
C.1 Introduction C.1.1 Many records are generated before and during the conduct of … |
| ICH ICH E6 Guideline R3 (2025) Appendix C-001 | G | Appendix C | EN | Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
C.1 Introduction C.1.1 Many records are generated before and during the conduct of … |
| ICH ICH E6 Guideline R3 (2025) Appendix C 2 | G | Appendix C 2 | EN | Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
[...] C.2 Management of Essential Records [...] C.2.4 The sponsor and investigator/i… |
| ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3 | G | Appendix C C.2.3 | EN | These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their res… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) | G | GLOSSARY - Adverse Drug Reaction (ADR) | EN | Adverse Drug Reaction (ADR): • in the pre-approval clinical experience with a new investigational product or its new usages (particularly as the ther… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) | G | GLOSSARY - Adverse Event (AE) | EN | Adverse Event (AE):
Any unfavourable medical occurrence in a trial participant administered the investigational product. The adverse event does not … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement | G | GLOSSARY - Agreement | EN | Agreement A document or set of documents describing the details of any arrangements on delegation or transfer, distribution and/or sharing of activit… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit | G | GLOSSARY - Audit | EN | Audit A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking | G | GLOSSARY - Blinding/Masking | EN | Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) | G | GLOSSARY - Case Report Form (CRF) | EN | Case Report Form (CRF) A tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial partic… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy | G | GLOSSARY - Certified Copy | EN | Certified Copy A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by genera… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial | G | GLOSSARY - Clinical Trial | EN | Clinical Trial Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharm… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR) | G | GLOSSARY - Clinical Trial/Study Report (CSR) | EN | Clinical Trial/Study Report (CSR) A documented description of a trial of any investigational product conducted in human participants, in which the cl… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator | G | GLOSSARY - Comparator | EN | Comparator An investigational or authorised medicinal product (i.e., active control), placebo or standard of care used as a reference in a clinical t… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) | G | GLOSSARY - Compliance (in relation to trials) | EN | Compliance (in relation to trials) Adherence to the trial-related requirements, GCP requirements and the applicable regulatory requirements.… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation | G | GLOSSARY - Computerised Systems Validation | EN | Computerised Systems Validation A process of establishing and documenting that the specified requirements of a computerised system can be consistentl… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) | G | GLOSSARY - Contract Research Organisation (CRO) | EN | Contract Research Organisation (CRO) See Service Provider.… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) | G | GLOSSARY - Data Acquisition Tool (DAT) | EN | Data Acquisition Tool (DAT) A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial acc… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Integrity | G | GLOSSARY - Data Integrity | EN | Data Integrity Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, contemporaneous, original, accurat… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC) | G | GLOSSARY - Independent Data Monitoring Committee (IDMC) | EN | Independent Data Monitoring Committee (IDMC) An independent data monitoring committee (e.g., data safety monitoring board) that may be established by … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed Consent | G | GLOSSARY - Informed Consent | EN | Informed Consent A process by which a participant or their legally acceptable representative voluntarily confirms their willingness to participate in … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection | G | GLOSSARY - Inspection | EN | Inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records and any other resources that are… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | G | GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | EN | Institutional Review Board (IRB)/Independent Ethics Committee (IEC) An independent body (a review board or a committee, institutional, regional, nati… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Interim Clinical Trial/Study Report | G | GLOSSARY - Interim Clinical Trial/Study Report | EN | Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of a trial.… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product | G | GLOSSARY - Investigational Product | EN | Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator | G | GLOSSARY - Investigator | EN | Investigator A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility dur… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) | G | GLOSSARY - Investigator’s Brochure (IB) | EN | Investigator’s Brochure (IB) A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata | G | GLOSSARY - Metadata | EN | Metadata The contextual information required to understand a given data element. Metadata is structured information that describes, explains or otherw… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment | G | GLOSSARY - Protocol Amendment | EN | Protocol Amendment A documented description of a change(s) to a protocol.… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation | G | GLOSSARY - Randomisation | EN | Randomisation The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in or… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities | G | GLOSSARY - Regulatory Authorities | EN | Regulatory Authorities Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) | G | GLOSSARY - Serious Adverse Event (SAE) | EN | Serious Adverse Event (SAE):
Any unfavourable medical occurrence that is considered serious at any dose if it: • Results in death, • Is life-threaten… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider | G | GLOSSARY - Service Provider | EN | Service Provider A person or organisation (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfil… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature | G | GLOSSARY - Signature | EN | Signature A unique mark, symbol or entry executed, adopted or authorised by an individual, in accordance with applicable regulatory requirements and/o… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records | G | GLOSSARY - Source Records | EN | Source Records Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor | G | GLOSSARY - Sponsor | EN | Sponsor An individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing … |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator | G | GLOSSARY - Sponsor-Investigator | EN | Sponsor-Investigator An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the i… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator | G | GLOSSARY - Sub-Investigator | EN | Sub-Investigator Any individual member of the clinical trial team designated and under the oversight of the investigator to perform significant trial-… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) | G | GLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR) | EN | Suspected Unexpected Serious Adverse Reaction (SUSAR):
an adverse reaction that meets three criteria: suspected, unexpected and serious. • Suspected… |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants | G | GLOSSARY - Vulnerable Participants | EN | Vulnerable Participants Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justifie… |
| ICH ICH E6 Guideline R3 (2025) I | G | I | EN | Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. … |
| ICH ICH E6 Guideline R3 (2025) II | G | II | EN | II. PRINCIPLES OF ICH GCP
[...] 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declara… |
| ICH ICH E6 Guideline R3 (2025) II 2.4 | G | II 2.4 | EN | 2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their l… |
| ICH ICH E6 Guideline R3 (2025) II 7.4 | G | II 7.4 | EN | 7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2 | G | III. Annex 3.17.2 | EN | 3. SPONSOR
[…] 3.17.2 Clinical Trial/Study Reports (a) Whether the trial is completed or prematurely terminated, or an interim analysis is undertaken … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 1 | G | III. Annex 1 1 | EN | 1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
[…] 1.1 Submission and Communication [...] 1.2 Responsibilities [...] 1.3 Composi… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7 | G | III. Annex 1 1.2.7 | EN | 1.2.7 If minors are to be included in a trial, the IRB/IEC should review the assent information considering the age, maturity and psychological state … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2 | G | III. Annex 1 2 | EN | 2. INVESTIGATOR
2.1 Qualifications and Training 2.1.1 The investigator(s) should be qualified by education, training and experience to assume respon… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 | G | III. Annex 1 2.10 | EN | 2.10 Investigational Product Management 2.10.1 Responsibility for investigational product(s) management, including accountability, handling, dispensi… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 | G | III. Annex 1 2.11 | EN | 2.11Randomisation Procedures and Unblinding The investigator should follow the trial’s randomisation procedures, if any, and, in the case of an inves… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.1 - 2.12.3 | G | III. Annex 1 2.12.1 - 2.12.3 | EN | 2.12 Records 2.12.1 In generating, recording and reporting trial data, the investigator should ensure the integrity of data under their responsibilit… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10 | G | III. Annex 1 2.12.10 | EN | 2.12.10 When using computerised systems in a clinical trial, the investigator/institution should do the following: (a)For systems deployed by the inv… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.11 – 2.12.14 | G | III. Annex 1 2.12.11 – 2.12.14 | EN | 2.12.11 The investigator/institution should maintain the trial records as specified in Appendix C and as required by the applicable regulatory require… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.5 – 2.12.9 | G | III. Annex 1 2.12.5 – 2.12.9 | EN | 2.12.5 The investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor in the data acquisitio… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13 | G | III. Annex 1 2.13 | EN | 2. INVESTIGATOR
[...] 2.13 Reports Upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/i… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.2 | G | III. Annex 1 2.2 | EN | 2.2 Resources 2.2.1 The investigator should be able to demonstrate (e.g., based on retrospective or currently available data) a potential for recruit… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3 | G | III. Annex 1 2.3 | EN | 2.3 Responsibilities
2.3.1 The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by t… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 | G | III. Annex 1 2.4.2 | EN | 2.4 Communication with IRB/IEC
[...] 2.4.2Before initiating a trial, the investigator/institution should have a documented and dated approval/favoura… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 | G | III. Annex 1 2.5 | EN | 2.5 Compliance with Protocol 2.5.1The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the spons… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6 | G | III. Annex 1 2.6 | EN | 2. INVESTIGATOR
[...] 2.6 Premature Termination or Suspension of a Trial 2.6.1 If the trial is prematurely terminated or suspended for any reason, th… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 | G | III. Annex 1 2.7.1 | EN | 2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 | G | III. Annex 1 2.7.1 | EN | 2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) | G | III. Annex 1
2.7.2 (a) | EN | 2.7.2 Safety Reporting
(a) [...] Unfavourable medical events occurring in participants before investigational product administration (e.g., during sc… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d) | G | III. Annex 1
2.7.2 (a) - (d) | EN | 2.7.2 Safety Reporting (a) Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be report… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8 | G | III. Annex 1 2.8 | EN | 2.8 Informed Consent of Trial Participants… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12 | G | III. Annex 1 2.8.12 | EN | 2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13 | G | III. Annex 1 2.8.13 | EN | 2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable repr… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8 | G | III. Annex 1 2.8.8 | EN | 2.8.8 In emergency situations, when prior consent of the participant is not possible, the consent of the participant’s legally acceptable representati… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9 | G | III. Annex 1 2.8.9 | EN | 2.8.9 If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) duri… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1 | G | III. Annex 1 2.9.1 | EN | 2.9 End of Participation in a Clinical Trial 2.9.1 When a participant decides to stop treatment with the investigational product or withdraw from a tr… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 | G | III. Annex 1 2.9.3 | EN | 2.9 End of Participation in a Clinical Trial
[...] 2.9.3 Where relevant, the investigator should inform the participant about the trial results and tr… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 | G | III. Annex 1 3 | EN | 3. SPONSOR… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4 | G | III. Annex 1 3.1.4 | EN | The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collec… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6 | G | III. Annex 1 3.10.1.6 | EN | 3.10.1.6 Risk Reporting The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded,… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 | G | III. Annex 1 3.11.2 | EN | 3.11 Quality Assurance and Quality Control
[...] 3.11.2 Audit When performed, audits should be conducted in a manner that is proportionate to the risk… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6 | G | III. Annex 1
3.11.4 3.11.4.3 - 3.11.4.6 | EN | 3.11 Quality Assurance and Quality Control
[...] 3.11.4 Monitoring The aim of monitoring is to ensure the participants’ rights, safety and well-being … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2 | G | III. Annex 1
3.11.4 3.11.4.1 - 3.11.4.2 | EN | 3.11.4 Monitoring
[...] Monitoring activities may include site monitoring (performed on-site or remotely) and centralised monitoring, depending on the… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2 | G | III. Annex 1 3.11.4.5.2 | EN | 3.11.4.5.2 Investigator Site Selection, Initiation, Management and Close-out
[...] (j) Confirming the arrangement for the retention of the essential r… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 | G | III. Annex 1 3.11.4.5.3 | EN | 3.11.4.5.3 Monitoring of Investigational Product Management
(a) Confirming, for the investigational product(s): (i) That storage conditions are acc… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 | G | III. Annex 1 3.12 | EN | 3.12 Noncompliance 3.12.1 Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirement(s) by an investigator/institution or by… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1 | G | III. Annex 1 3.13.1 | EN | 3.13.1 Sponsor Review of Safety Information The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. T… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f) | G | III. Annex 1
3.13.2 (a) - (b) ; (d) - (f) | EN | 3.13.2 Safety Reporting (a) The sponsor should submit to the regulatory authority(ies) safety updates and periodic reports, including changes to the I… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c) | G | III. Annex 1
3.13.2 (c) | EN | 3.13.2 Safety Reporting
[...] (c) Safety reporting to regulatory authorities should be undertaken by assessing the expectedness of the reaction in rel… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001 | G | III. Annex 1 3.14 | EN | 3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the spo… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002 | G | III. Annex 1 3.14 | EN | 3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the spo… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 | G | III. Annex 1 3.15 | EN | 3.15 Investigational Product(s)
[...] (d) In blinded trials, the sponsor should implement: (i) A process to blind individuals, including the sponso… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) | G | III. Annex 1
3.16.1 (g) | EN | 3.16.1 Data Handling
[...] (g) Procedures should be in place to describe unblinding; where applicable; these descriptions should include: (i) who … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution | G | III. Annex 1
3.16.1 For systems used or deployed by the investigator/institution | EN | 3.16 Data and Records
3.16.1 Data Handling [...] For systems used or deployed by the investigator/institution: [...] (vii) In situations where clinica… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1 | G | III. Annex 1 3.17.1 | EN | 3. SPONSOR
[...] 3.17.1Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly i… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5 | G | III. Annex 1 3.5 | EN | 3.5 Financing The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6 | G | III. Annex 1 3.6 | EN | 3.6 Agreements 3.6.1 Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8 | G | III. Annex 1 3.8 | EN | 3. SPONSOR
[...] 3.8 Communication with IRB/IEC and Regulatory Authority(ies) 3.8.1 Notification/Submission to Regulatory Authority(ies) In accordanc… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9 | G | III. Annex 1 3.9 | EN | 3.9 Sponsor Oversight
[...] 3.9.7 The sponsor may consider establishing an IDMC to assess the progress of a clinical trial, including the safety data … |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 | G | III. Annex 1 3.9.3 | EN | 3.9.3 The sponsor should determine necessary trial-specific criteria for classifying protocol deviations as important. Important protocol deviations a… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4 | G | III. Annex 1 4 | EN | 4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 | G | III. Annex 1 4.1 | EN | 4.1Safeguard Blinding in Data Governance 4.1.1 Maintaining the integrity of the blinding is important in particular in the design of systems, manageme… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1 | G | III. Annex 1 4.2.1 | EN | 4.2 Data Life Cycle Elements
Procedures should be in place to cover the full data life cycle. 4.2.1 Data Capture (a) When data captured on paper or… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 | G | III. Annex 1 4.2.3 - 4.2.4 | EN | 4.2.3 Review of Data and Metadata Procedures for review of trial-specific data, audit trails and other relevant metadata should be in place. It should… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3 | G | III. Annex 1 4.3 | EN | 4.3 Computerised Systems As described in sections 2 and 3, the responsibilities of the sponsor, investigator and the activities of other parties with… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3 | G | III. Annex 1 4.3.3 | EN | 4.3.3 Security
(a) The security of the trial data and records should be managed throughout the data life cycle. (b) The responsible party should ens… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 | G | III. Annex 1 4.3.4 | EN | 4.3.4 Validation (a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validatio… |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8 | G | III. Annex 1 4.3.8 | EN | 4.3.8 User Management (a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and… |
