Data storage
ADVERSE EVENTS
Data stored on the trial database will be pseudonymised by linking to a unique participant ID number only. The name and any other identifying details will not be included in the trial data electronic file used for analysis or publication. A risk assessment for the trial database will be conducted, covering all the risks associated to the front-end and back-end security of the systems, outlined in the I’M WOMAN Database Development and Validation Plan. The LSHTM CTU Global Health Trials Group will provide an Investigator Site File (ISF) containing the essential trial documents, which the site must keep updated throughout the trial. Original copies of CRFs, consent forms, and source data will be kept securely at each participating site. These must be archived securely for 10 years after the overall end of the trial. Source documents include, but are not limited to, hospital records (from which medical history, previous and concurrent medication, clinical outcomes, and adverse events may be summarised onto CRFs), clinical and office logbooks, laboratory and pharmacy records, diaries, and correspondence. On all trial-specific documents other than the consent form, we will refer to the participant by their screening ID number and randomisation number. Study sites will provide data access to authorised representatives of the sponsor, the host institution, and regulatory authorities to allow trial-related monitoring, audits, and inspections.