9.1 The quality and amount of the information generated in a clinical trial should be fit for purpose and sufficient to provide confidence in the trial’s results and support good decision making.
9.2 Systems and processes that aid in data capture, management and analyses, as well as those that help ensure the quality of the information generated from the trial, should be fit for purpose, should capture the data required by the protocol and should be implemented in a way that is proportionate to the risks to participants and the importance of acquired data.
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.
9.4 Clinical trials should incorporate efficient and robust processes for managing records (including data) to help ensure that record integrity and traceability are maintained and that personal information is protected, thereby allowing the accurate reporting, interpretation and verification of the relevant clinical trial-related information.
9.5 Essential records should be retained securely by sponsors and investigators for the required period in accordance with applicable regulatory requirements. 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.
9.6 The transparency of clinical trials includes timely registration on publicly accessible and recognised databases and the public posting of clinical trial results. Communicating trial results to participants should be considered. Such communication should be objective and non- promotional.