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 investigator/institution should maintain adequate source records that include pertinent observations on each of the trial participants under their responsibility. Source records should be attributable, legible, contemporaneous, original, accurate and complete. Changes to source records should be traceable, should not obscure the original entry and should be explained if necessary (via an audit trail). The investigator should define what is considered to be a source record(s), the methods of data capture and their location prior to starting the trial and should update this definition when needed. Unnecessary transcription steps between the source record and the data acquisition tool should be avoided.
2.12.3 The investigator should be provided with timely access to data by the sponsor (see section 3.16.1(k)) and be responsible for the timely review of data, including relevant data from external sources that can have an impact on, for example, participant eligibility, treatment or safety (e.g., central laboratory data, centrally read imaging data, other institution’s records and, if appropriate, electronic patient-reported outcome (ePRO) data). The protocol may provide exceptions for access, for instance, to protect blinding.
2.12.4 The investigator should ensure that data acquisition tools and other systems deployed by the sponsor are used as specified in the protocol or trial-related instructions.
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., case report form (CRF)) and in any other required reports (e.g., SAE reports). 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)).
2.12.6 Data reported to the sponsor should be consistent with the source records or the discrepancies explained. Changes or corrections in the reported data should be traceable, should be explained (if necessary) and should not obscure the original entry.
2.12.7 The investigator/institution should implement appropriate measures to protect the privacy and confidentiality of personal information of trial participants in accordance with applicable regulatory requirements on personal data protection.
2.12.8 Data reported to the sponsor should be identified by an unambiguous participant code that can be traced back to the identity of the participant by the investigator/institution.
2.12.9 For systems deployed by the investigator/institution that maintain and retain trial data/information, the investigator/institution should ensure that such data are protected from unauthorised access, disclosure, dissemination or alteration and from inappropriate destruction or accidental loss.
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 individuals have secure and attributable access;
(b) For systems deployed by the sponsor, notify the sponsor when access permissions need to be changed or revoked from an individual;
(c) For systems deployed by the investigator/institution specifically for the purposes of clinical trials, ensure that the requirements for computerised systems in section 4 are addressed proportionate to the risks to participants and to the importance of the data;
(d) Where equipment for data acquisition is provided to trial participants by the investigator, ensure that traceability is maintained and that participants are provided with appropriate training;
(e) Ensure that incidents in the use and operation of computerised systems, which in the investigator’s/institution’s judgement may have a significant and/or persistent impact on the trial data or system security, are reported to the sponsor and, where applicable, to the IRB/IEC.
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 control of all essential records generated by the investigator/institution before and during the conduct of the trial.
2.12.12 The investigator/institution should retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution that these records are no longer needed, whichever is the longest. The investigator/institution should take measures to ensure availability, accessibility and readability and to prevent unauthorised access and accidental or premature destruction of these records (see Appendix C).
2.12.13 The investigator/institution should keep the sponsor informed of the name of the person responsible for maintaining the essential records during the retention period; for example, when the investigator site closes or an investigator leaves the site.
2.12.14 Upon request of the monitor, auditor, IRB/IEC or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records.