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.
10. Roles and responsibilities in clinical trials should be clear and documented appropriately.
10.1 The sponsor may transfer or the investigator may delegate their tasks, duties or functions (hereafter referred to as activities), but they retain overall responsibility for their respective activities.
10.2 Agreements should clearly define the roles, activities and responsibilities for the clinical trial and be documented appropriately. 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.
10.3 The sponsor or investigator should maintain appropriate oversight of the aforementioned activities.
11. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol.
11.1 Investigational products used in a clinical trial should be manufactured in accordance with applicable GMP standards.
11.2 Measures should be in place to ensure that the investigational product provided to trial participants retains its quality.
11.3 Investigational products should be used in accordance with the protocol and relevant trial documents.
11.4 Manufacturing, handling and labelling of investigational products should be undertaken in a manner that aligns with treatment assignment and maintains blinding, where applicable.
11.5 Investigational product labelling should follow applicable regulatory requirements.
11.6 Appropriate processes should be implemented for the handling, shipping, storage, dispensing, returning and destroying or alternatively disposing of the investigational product.