Clinical trials

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Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable.

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Guideline Scope This guideline applies to interventional clinical trials of investigational products1 that are intended to be submitted to regulatory authorities.

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The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial.

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Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials.

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The principles are interdependent and should be considered in their totality to assure ethical trial conduct and reliable results.

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The participant selection process should be representative of the population groups that the investigational product is intended to benefit, once authorised, to allow for generalising the results across the broader population.

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For potential participants unable to provide informed consent, their legally acceptable representatives, acting in the participants’ best interest, should provide consent prior to clinical trial participation.

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In the event that a minor is a participant, assent should be collected from that minor, as appropriate, and in accordance with local regulatory requirements (see ICH E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population).

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Individuals involved in a trial should be qualified by education, training and experience to perform their respective task(s).

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These factors are attributes of a trial that are fundamental to the protection of participants, the reliability and interpretability of the trial results and the decisions made based on those trial results.

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9.3 Computerised systems used in clinical trials should be fit for purpose (e.g., through risk-based validation, if appropriate), and factors critical to their quality should be addressed in their design or adaptation for clinical trial purposes to ensure the integrity of relevant trial data.

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These essential records should be available to regulatory authorities, monitors, auditors and IRBs/IECs (as appropriate) upon request to enable appropriate evaluation of the trial conduct in order to ensure the reliability of trial results.

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Where activities have been transferred or delegated to service providers, the responsibility for the conduct of the trial, including quality and integrity of the trial data, resides with the sponsor or investigator, respectively.

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For the submission to or communication with the IRB/IEC, in most regions where there is also a requirement to make a submission to the relevant regulatory authority, these may be combined in a single submission in accordance with applicable regulatory requirements.

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Submissions and communications with the IRB/IEC and regulatory authorities are made in some regions by the investigator/institution and by the sponsor in other regions in accordance with applicable regulatory requirements.

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Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant.

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It is recommended that the IRB/IEC should include: (a) At least five members; (b) At least one member whose primary area of interest is not in medical sciences; (c) At least one member who is independent of the institution/investigator site.

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The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor (see section 3.6.5).

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The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data.

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In addition to those identified by the investigator themselves, protocol deviations relevant to their trial participants and their conduct of the trial may be communicated to them by the sponsor (see section 3.11.4.5.1(b)).

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In either case, the investigator should review the deviations, and for those deviations deemed important, the investigator should explain the deviation and implement appropriate measures to prevent a recurrence, where applicable (see section 3.9.3).

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(a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements) who is an investigator or a sub-investigator for the trial should have the responsibility for trial-related medical care and decisions.

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(b) Other appropriately qualified healthcare professionals may be involved in the medical care of trial participants, in line with their normal activities and in accordance with local regulatory requirements.

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(b) All serious adverse events (SAEs) should be reported immediately (after the investigator reasonably becomes aware of the event) to the sponsor.

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In accordance with applicable regulatory requirements, the protocol may identify SAEs not requiring immediate reporting; for example, deaths or other events that are endpoints.

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(e) Whether the informed consent process takes place in person or remotely, the investigator should assure themselves of the identity of the participant (or legally acceptable representative) in accordance with applicable regulatory requirements.

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The communication of this information and confirmation of the willingness to continue trial participation should be documented.

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The informed consent process may involve a physical or an electronic signature and date (see the glossary term “signature”).

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When prior consent of the participant is not possible and the participant’s legally acceptable representative is not available, enrolment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the participant’s rights, safety and well-being and to ensure compliance with applicable regulatory requirements.

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During trial participation, the participant or the participant’s legally acceptable representative should receive a copy of the consent form updates and any other updated informed consent materials provided.

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A process for consent should be considered if, during the course of the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.

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The investigator or delegated investigator site staff should consider explaining to the participant the value of continuing their participation to minimise trial participants withdrawal.

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In this process, the investigator should ensure that it does not interfere with the participant’s decision to refuse or withdraw participation at any time.

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The investigator should review and endorse the reported data at important milestones agreed upon with the sponsor (e.g., interim analysis) (see section 3.16.1(o)).

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(a) Where reference is made to a submission to the IRB/IEC, this can be made by the investigator/institution or sponsor in accordance with applicable regulatory requirements (see section 1.1).

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The sponsor should adopt a proportionate and riskbased approach to quality management, which involves incorporating quality into the design of the clinical trial (i.e., quality by design) and identifying those factors that are likely to have a meaningful impact on participants’ rights, safety and well-being and the reliability of the results (i.e., critical to quality factors as described in ICH E8(R1)).

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The sponsor should describe the quality management approach implemented in the trial in the clinical trial report (see ICH E3 Structure and Content of Clinical Study Reports).

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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 remedial actions taken and document them in the clinical trial report (see ICH E3).

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When performed, audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial (see section 3.10.1.1).

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(a) Selecting the site and confirming that the investigator and individuals or parties involved in the trial conduct have adequate qualifications, resources (see sections 2.1, 2.2 and 3.7) and facilities, including laboratories, equipment and investigator site staff, to conduct the trial safely and properly.

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(d) Confirming that informed consent was obtained before participation in the trial (see section 2.8) for trial participants at the site.

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(b) The sponsor should, in accordance with the applicable regulatory requirement(s) and with ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, expedite the reporting to the regulatory authority(ies) of all suspected, unexpected and serious adverse reactions (i.e., SUSARs).

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Alternatively, for authorised medicinal products, the sponsor should identify the basic product information to be used in the trial (see Appendix A, section A.1.1).

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(e) The sponsor should ensure that documented processes are implemented to ensure the data integrity for the full data life cycle (see section 4.2).

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This enables the investigators to make decisions (e.g., on eligibility, treatment, continuing participation in the trial and care for the safety of the individual trial participants) (see section 2.12.3).

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These steps may vary depending on the purpose of the analysis to be conducted (e.g., data for IDMC, for interim analysis or the final analysis) (see section 4.2.6).

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(b) The sponsor should ensure that trial participants have consented to direct access to source records for the purposes outlined in 3.16.4(a) (see section 2.8.10(n)).

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The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of ICH E3 or are otherwise in accordance with applicable regulatory requirements.

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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 trials should be clear and documented.

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INVESTIGATOR’S BROCHURE A.1 Introduction The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s)1 that are relevant to the study of the product(s) in human participants.

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A.1.1 Development of the Investigator’s Brochure Generally, the sponsor is responsible for ensuring that an up-to-date IB is developed.

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A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)), and a brief summary should be given of the relevant physical, chemical and pharmaceutical properties.

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A.3.5 Nonclinical Studies Introduction The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic and investigational product metabolism studies should be provided in summary form.

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B.2.2 A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.

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B.2.5 A statement that the trial will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

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B.4.2 A description of the type and design of trial to be conducted (e.g., double-blind, placebo-controlled, parallel design, adaptive design, platform/umbrella/basket, trials with decentralised elements) and a schematic diagram of trial design, procedures and stages.

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B.4.3 A description of the measures taken to minimise/avoid bias, including: (a) Randomisation (b) Blinding B.4.4 A description of the investigational product(s) and the dosage and dosage regimen of the investigational product(s), including a description of the dosage form, packaging and labelling.

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Conversely, the participant may decide to withdraw from the trial or stop treatment with the investigational product (see sections 2.8.10(l), 2.8.10(m) and 2.9.1).

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B.7 Treatment and Interventions for Participants B.7.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the criteria for dose adjustment(s), the route/mode(s) of administration and the treatment period(s), including the follow-up period(s) for participants for each investigational product treatment/trial treatment group/arm of the trial.

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B.10 Statistical Considerations B.10.1 A description of the statistical methods to be employed, including timing and purpose of any planned interim analysis(ses) and the statistical criteria for the stopping of the trial.

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B.10.2 The number of participants planned to be enrolled and the reason for the choice of sample size, including reflections on or calculations of the power of the trial and clinical justification.

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B.14.2 The identification of data to be recorded directly into the data acquisition tools (i.e., no prior written or electronic record of data) and considered to be the source record.

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C.2 Management of Essential Records C.2.1 Records should be identifiable and version controlled (when appropriate) and should include authors, reviewers and approvers as appropriate, along with date and signature (electronic or physical), where necessary.

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C.2.2 For activities that are transferred or delegated to service providers by the sponsor or investigator/institution, respectively, arrangements should be made for the access and management of the essential records throughout the trial and for their retention following completion of the trial.

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C.2.6 The sponsor and investigator/institution should retain the essential records in a way that ensures that they remain complete, readable and readily available and are directly accessible upon request by regulatory authorities, monitors and auditors.

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python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom019_t07_primary_claims.json --source-file <local-raw-pdf>

C.2.7 The sponsor and investigator/institution should ensure the retention of the essential records required to fulfil their responsibility.

Evidence card JSONRendered card

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C.3.2 Applying the criteria in section C.3.1, the trial records that are considered essential are listed in the Essential Records Table, and these should be retained when produced.

Evidence card JSONRendered card

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python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom019_t07_primary_claims.json --source-file <local-raw-pdf>

C.3.3 For some trial records listed in the Essential Record Table, their presence and nature are dependent on the trial design, trial conduct and risk proportionate management of the trial and may not be produced.

Evidence card JSONRendered card

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python scripts/verify_primary_public_claim_group.py artifacts/cb7k_dom019_t07_primary_claims.json --source-file <local-raw-pdf>

(see ICH E2A) An important medical event that may not be immediately life-threatening or result in death or hospitalisation, that may jeopardise the participant or that may require intervention to prevent serious outcomes (see ICH E2A and E19) should generally be considered as serious.

Evidence card JSONRendered card

Download the PDF to a local file, then run the committed verifier. A changed PDF is reported as drift rather than silently accepted.

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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 and analyses are fully integrated into a single report (see ICH E3 Structure and Content of Clinical Study Reports).

Evidence card JSONRendered card