Confidentiality {27}
CRF
CRF
The trial staff will ensure that participants’ confidentiality is maintained. Any identifiable data obtained by the LSHTM CTU Global Health Trials Group will be stored securely and confidentiality protected in accordance with relevant Data Protection regulations including the UK General Data Protection Regulation (GDPR) 2018. Participants will be identified only by a participant screening ID and randomisation number on all trial documents and any electronic database, except for the paper CRF which remains at participating sites, where participant initials may be added. All documents will be stored securely and only accessible by the trial staff and authorised personnel. The LSHTM CTU Global Health Trials Group will securely store copies of consent forms sent for monitoring, and these will be destroyed at trial closure. Only people authorised by the chief investigator, project lead, or trial manager will have access to the I’M WOMAN trial database. The trial database will be accessed through a complex password system which includes a password ageing mechanism (i.e. passwords will be changed every 90 days).