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Document:ICH ICH E6 Guideline R3 (2025): Difference between revisions

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|reference=ICH  ICH E6 Guideline  R3 (2025)
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<noinclude>
== References ==
{| class="wikitable"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference: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 description of the trial design should include: ...
|-
| [[Reference: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. Clinical trials conducted in accordance with this ...
|-
| [[Reference: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 Declaration of Helsinki and that are consistent with GCP ...
|-
| [[Reference: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 pharmacodynamic effects of an investigational ...
|-
| [[Reference: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 inspections. These bodies are sometimes referred ...
|-
| [[Reference: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, national or supranational) constituted of medical ...
|-
| [[Reference: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 Composition, Functions and Operations [...] 1.4 ...
|-
| [[Reference: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 accordance with applicable regulatory requirement(s), ...
|-
| [[Reference: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 a clinical trial. The nature and extent of those ...
|-
| [[Reference: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 respective records. These repositories may be ...
|-
| [[Reference: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 protocol. The protocol should be designed in such a ...
|-
| [[Reference: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 the key trial objectives. The sponsor should not ...
|-
| [[Reference: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 investigational product(s) in human participants ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) Appendix A]] || G || Appendix A || EN || Appendix A. INVESTIGATOR’S BROCHURE
|-
| [[Reference: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 a clinical trial. The nature and extent of those ...
|-
| [[Reference: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.
|-
| [[Reference: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 trial-related activities.
|-
| [[Reference: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 of a clinical trial. A clinical trial may have ...
|-
| [[Reference: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 investigational product is administered to, ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3]] || G || III. Annex 1
3 || EN || 3. SPONSOR
|-
| [[Reference: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 during the conduct of the trial. If a trial is ...
|-
| [[Reference: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 responsibility for the proper conduct of the trial and ...
|-
| [[Reference: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-related procedures and/or to make important ...
|-
| [[Reference: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 the sponsor in the identification of a suitable ...
|-
| [[Reference: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 recruiting the proposed number of eligible participants ...
|-
| [[Reference: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.
|-
| [[Reference: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 activities and, if appropriate, on financial matters ...
|-
| [[Reference: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 monitoring committee (IDMC), adjudication ...
|-
| [[Reference: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 sponsor should provide insurance or should indemnify ...
|-
| [[Reference: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 professionals in accordance with local regulatory ...
|-
| [[Reference: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 a trial after having been informed and been ...
|-
| [[Reference: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
|-
| [[Reference: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 trial; is discontinued from the trial; or reaches ...
|-
| [[Reference: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 justified or not, of benefits associated with participation ...
|-
| [[Reference: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) during the entire informed consent discussion. After ...
|-
| [[Reference: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 of the minor population intended to be enrolled, ...
|-
| [[Reference: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 the consent process, and assent from the minor ...
|-
| [[Reference: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 representative, the participants should be informed ...
|-
| [[Reference: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 representative, if present, should be requested. When prior ...
|-
| [[Reference: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 legally acceptable representative as soon as ...
|-
| [[Reference: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/favourable opinion from the IRB/IEC for the trial ...
|-
| [[Reference: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 appropriate, and screening of participants.
|-
| [[Reference: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 trial. Conversely, the participant may decide to ...
|-
| [[Reference: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 to the participant(s) being unaware, and ...
|-
| [[Reference: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 order to reduce bias.
|-
| [[Reference: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 investigator-blinded trial, should ensure that the ...
|-
| [[Reference: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 sponsor staff, trial participant, investigator and/or ...
|-
| [[Reference: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 treatment received when this information is ...
|-
| [[Reference: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 were unblinded, at what timepoint and for what ...
|-
| [[Reference: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, management of users’ accounts, delegation of ...
|-
| [[Reference: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 product with a marketing authorisation when used ...
|-
| [[Reference: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 trial.
|-
| [[Reference: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, dispensing, administration and return, rests with the ...
|-
| [[Reference: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 acceptable and in accordance with the storage ...
|-
| [[Reference: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.
|-
| [[Reference: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 sponsor. 2.5.2The investigator should comply with the ...
|-
| [[Reference: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, Good Clinical Practice (GCP) and the applicable ...
|-
| [[Reference: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 member(s) of the sponsor’s staff should lead to ...
|-
| [[Reference: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 protocol or GCP.
|-
| [[Reference: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 are a subset of protocol deviations that may ...
|-
| [[Reference: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, accurate, complete, secure and reliable such that data ...
|-
| [[Reference: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 the media used. This may include trial ...
|-
| [[Reference: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 otherwise makes it easier to retrieve, use or manage ...
|-
| [[Reference: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 generation through a validated process) to have the same ...
|-
| [[Reference: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 responsibility, irrespective of the media used. 2.12.2 The ...
|-
| [[Reference: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 acquisition tools completed by the investigator site (e.g., ...
|-
| [[Reference: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 requirement(s). The investigator/institution should have ...
|-
| [[Reference: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 collection. Protocols, data acquisition tools and other ...
|-
| [[Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4]] || G || III. Annex 1
4 || EN || 4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR
|-
| [[Reference: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 investigator/institution, ensure that appropriate ...
|-
| [[Reference: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 clinical practice computerised systems are being ...
|-
| [[Reference: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 respect to a computerised system used in clinical ...
|-
| [[Reference: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 ensure that security controls are implemented and ...
|-
| [[Reference: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 consistently fulfilled from design until decommissioning of ...
|-
| [[Reference: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 validation of computerised systems should be based on a ...
|-
| [[Reference: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 to ensure attributability to an individual. The ...
|-
| [[Reference: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/or practice to show expression of will and allow ...
|-
| [[Reference: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 participant (see Data Acquisition Tool).
|-
| [[Reference: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 according to the protocol and to report the data to ...
|-
| [[Reference: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 in an electronic health record are manually ...
|-
| [[Reference: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 be a planned activity, and the extent and nature ...
|-
| [[Reference: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 and the reliability of trial results as the trial ...
|-
| [[Reference: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 monitoring strategy and the design of the ...
|-
| [[Reference: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.
|-
| [[Reference: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 research organisation (CRO)) or institution to ...
|-
| [[Reference: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 risks associated with the conduct of the trial (see ...
|-
| [[Reference: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 deemed by the authority(ies) to be related to the ...
|-
| [[Reference: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 necessarily have a causal relationship with the ...
|-
| [[Reference: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-threatening, • Requires inpatient hospitalisation or ...
|-
| [[Reference: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. This includes the review of any reported ...
|-
| [[Reference: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 screening) should be considered and reported to the ...
|-
| [[Reference: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 therapeutic dose(s) may not be established): ...
|-
| [[Reference: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: There is a reasonable possibility that the drug ...
|-
| [[Reference: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 reported to the sponsor according to the reporting ...
|-
| [[Reference: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 Investigator’s Brochure, as required by applicable ...
|-
| [[Reference: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 the sponsor to assess at intervals the progress ...
|-
| [[Reference: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 and the efficacy endpoints, at intervals and to ...
|-
| [[Reference: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 applicable. B.8.2 Methods and timing for ...
|-
| [[Reference: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 relation to the applicable product information ...
|-
| [[Reference: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 professionals in accordance with local regulatory ...
|-
| [[Reference: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 provided of the investigational product substance(s) ...
|-
| [[Reference: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 individual participants, for parts of the trial or for ...
|-
| [[Reference: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 trial. Conversely, the participant may decide to ...
|-
| [[Reference: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 individual participants, for parts of the trial or for ...
|-
| [[Reference: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.
|-
| [[Reference: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 sponsor should provide insurance or should indemnify ...
|-
| [[Reference: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, the investigator/institution should promptly inform ...
|-
| [[Reference: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 inform the investigators/institutions and the ...
|-
| [[Reference: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 records and the final accountability of the ...
|-
| [[Reference: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/institution should maintain a record of where ...
|-
| [[Reference: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 should be retained in accordance with applicable ...
|-
| [[Reference: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.
|-
| [[Reference: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 clinical and statistical description, presentations ...
|-
| [[Reference: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/institution should provide the IRB/IEC with a ...
|-
| [[Reference: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 for regulatory submission, the sponsor should ...
|-
| [[Reference: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, as detailed in section 3.10.1.3) and the ...
|-
| [[Reference: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.
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


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

 ScopeDocument partLanguagePreview
ICH ICH E6 Guideline R3 (2025) Appendix AGAppendix AENAppendix A. INVESTIGATOR’S BROCHURE…
ICH ICH E6 Guideline R3 (2025) Appendix A 3.4GAppendix A 3.4ENA.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 BGAppendix BENAppendix 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 12.3GAppendix B 12.3ENAppendix 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 14.3GAppendix B 14.3ENAppendix 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 16GAppendix B 16ENB.16 Publication Policy Publication policy, if not addressed in a separate agreement.…
ICH ICH E6 Guideline R3 (2025) Appendix B 2.5GAppendix B 2.5ENAppendix 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 4.8-001GAppendix B 4.8ENB.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 4.8-002GAppendix B 4.8ENB.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 5GAppendix B 5ENB.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 6-001GAppendix B 6ENB.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 6-002GAppendix B 6ENB.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 8GAppendix B 8ENAppendix 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 9.4GAppendix B 9.4ENB.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. B4GAppendix B. B4ENB.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-002GAppendix CENAppendix 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-001GAppendix CENAppendix 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 2GAppendix C 2ENAppendix 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.2.3GAppendix C C.2.3ENThese 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)GGLOSSARY - Adverse Drug Reaction (ADR)ENAdverse 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)GGLOSSARY - Adverse Event (AE)ENAdverse 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 - AgreementGGLOSSARY - AgreementENAgreement 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 - AuditGGLOSSARY - AuditENAudit 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/MaskingGGLOSSARY - Blinding/MaskingENBlinding/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)GGLOSSARY - Case Report Form (CRF)ENCase 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 CopyGGLOSSARY - Certified CopyENCertified 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 TrialGGLOSSARY - Clinical TrialENClinical 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)GGLOSSARY - Clinical Trial/Study Report (CSR)ENClinical 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 - ComparatorGGLOSSARY - ComparatorENComparator 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)GGLOSSARY - Compliance (in relation to trials)ENCompliance (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 ValidationGGLOSSARY - Computerised Systems ValidationENComputerised 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)GGLOSSARY - Contract Research Organisation (CRO)ENContract Research Organisation (CRO) See Service Provider.…
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT)GGLOSSARY - Data Acquisition Tool (DAT)ENData 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 IntegrityGGLOSSARY - Data IntegrityENData 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)GGLOSSARY - Independent Data Monitoring Committee (IDMC)ENIndependent 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 ConsentGGLOSSARY - Informed ConsentENInformed 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 - InspectionGGLOSSARY - InspectionENInspection 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)GGLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC)ENInstitutional 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 ReportGGLOSSARY - Interim Clinical Trial/Study ReportENInterim 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 ProductGGLOSSARY - Investigational ProductENInvestigational 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 - InvestigatorGGLOSSARY - InvestigatorENInvestigator 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)GGLOSSARY - Investigator’s Brochure (IB)ENInvestigator’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 - MetadataGGLOSSARY - MetadataENMetadata 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 AmendmentGGLOSSARY - Protocol AmendmentENProtocol Amendment A documented description of a change(s) to a protocol.…
ICH ICH E6 Guideline R3 (2025) GLOSSARY - RandomisationGGLOSSARY - RandomisationENRandomisation 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 AuthoritiesGGLOSSARY - Regulatory AuthoritiesENRegulatory 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)GGLOSSARY - Serious Adverse Event (SAE)ENSerious 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 ProviderGGLOSSARY - Service ProviderENService 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 - SignatureGGLOSSARY - SignatureENSignature 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 RecordsGGLOSSARY - Source RecordsENSource 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 - SponsorGGLOSSARY - SponsorENSponsor 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-InvestigatorGGLOSSARY - Sponsor-InvestigatorENSponsor-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-InvestigatorGGLOSSARY - Sub-InvestigatorENSub-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)GGLOSSARY - Suspected Unexpected Serious Adverse Reaction (SUSAR)ENSuspected 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 ParticipantsGGLOSSARY - Vulnerable ParticipantsENVulnerable 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) IGIENGood 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) IIGIIENII. 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 2.4GII 2.4EN2.4 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 7.4GII 7.4EN7.4 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 3.17.2GIII. Annex 3.17.2EN3. 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 1GIII. Annex 1 1EN1. 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 1.2.7GIII. Annex 1 1.2.7EN1.2.7 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 2GIII. Annex 1 2EN2. 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 2.10GIII. Annex 1 2.10EN2.10 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 2.11GIII. Annex 1 2.11EN2.11Randomisation 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 - 2.12.3GIII. Annex 1 2.12.1 - 2.12.3EN2.12 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 2.12.10GIII. Annex 1 2.12.10EN2.12.10 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 – 2.12.14GIII. Annex 1 2.12.11 – 2.12.14EN2.12.11 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 – 2.12.9GIII. Annex 1 2.12.5 – 2.12.9EN2.12.5 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 2.13GIII. Annex 1 2.13EN2. 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 2.2GIII. Annex 1 2.2EN2.2 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 2.3GIII. Annex 1 2.3EN2.3 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 2.4.2GIII. Annex 1 2.4.2EN2.4 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 2.5GIII. Annex 1 2.5EN2.5 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 2.6GIII. Annex 1 2.6EN2. 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 2.7.1-001GIII. Annex 1 2.7.1EN2.7.1 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 2.7.1-002GIII. Annex 1 2.7.1EN2.7.1 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)GIII. Annex 1

2.7.2

(a)		EN2.7.2 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)GIII. Annex 1

2.7.2

(a) - (d)		EN2.7.2 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 2.8GIII. Annex 1 2.8EN2.8 Informed Consent of Trial Participants…
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12GIII. Annex 1 2.8.12EN2.8.12 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 2.8.13GIII. Annex 1 2.8.13EN2.8.13 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 2.8.8GIII. Annex 1 2.8.8EN2.8.8 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 2.8.9GIII. Annex 1 2.8.9EN2.8.9 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 2.9.1GIII. Annex 1 2.9.1EN2.9 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 2.9.3GIII. Annex 1 2.9.3EN2.9 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 3GIII. Annex 1 3EN3. SPONSOR…
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4GIII. Annex 1 3.1.4ENThe 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 3.10.1.6GIII. Annex 1 3.10.1.6EN3.10.1.6 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 3.11.2GIII. Annex 1 3.11.2EN3.11 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 - 3.11.4.6GIII. Annex 1

3.11.4

3.11.4.3 - 3.11.4.6		EN3.11 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 - 3.11.4.2GIII. Annex 1

3.11.4

3.11.4.1 - 3.11.4.2		EN3.11.4 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 3.11.4.5.2GIII. Annex 1 3.11.4.5.2EN3.11.4.5.2 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 3.11.4.5.3GIII. Annex 1 3.11.4.5.3EN3.11.4.5.3 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 3.12GIII. Annex 1 3.12EN3.12 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 3.13.1GIII. Annex 1 3.13.1EN3.13.1 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)GIII. Annex 1

3.13.2

(a) - (b) ; (d) - (f)		EN3.13.2 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)GIII. Annex 1

3.13.2

(c)		EN3.13.2 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 3.14-001GIII. Annex 1 3.14EN3.14 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 3.14-002GIII. Annex 1 3.14EN3.14 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 3.15GIII. Annex 1 3.15EN3.15 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)GIII. Annex 1

3.16.1

(g)		EN3.16.1 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/institutionGIII. Annex 1

3.16.1

For systems used or deployed by the investigator/institution		EN3.16 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 3.17.1GIII. Annex 1 3.17.1EN3. 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 3.5GIII. Annex 1 3.5EN3.5 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 3.6GIII. Annex 1 3.6EN3.6 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 3.8GIII. Annex 1 3.8EN3. 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 3.9GIII. Annex 1 3.9EN3.9 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 3.9.3GIII. Annex 1 3.9.3EN3.9.3 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 4GIII. Annex 1 4EN4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR…
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1GIII. Annex 1 4.1EN4.1Safeguard 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 4.2.1GIII. Annex 1 4.2.1EN4.2 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 - 4.2.4GIII. Annex 1 4.2.3 - 4.2.4EN4.2.3 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 4.3GIII. Annex 1 4.3EN4.3 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 4.3.3GIII. Annex 1 4.3.3EN4.3.3 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 4.3.4GIII. Annex 1 4.3.4EN4.3.4 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 4.3.8GIII. Annex 1 4.3.8EN4.3.8 User Management (a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and…
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