Drug storage and supply
HEAT, RECRUITMENT
When a site is ready to start, a box of treatment packs will be sent by the LSHTM CTU Global Health Trials Group or the in-country coordinating centre. Site stock level depends on the site’s average recruitment rate. Each time a participant is randomised and entered into the trial database, one pack from the site’s stock will be automatically deducted. When the stock reaches the site’s minimum level, the LSHTM CTU Global Health Trials Group or in-country coordinating centre will send another box (or boxes). Sites should send screening and entry data to the LSHTM CTU Global Health Trials Group as soon as possible after randomisation (ideally within 24 h). Sites must report all used, lost or damaged trial treatment packs to the LSHTM CTU Global Health Trials Group on a Drug Accountability Log.At each site, the treatment packs will be stored securely in a place where they are always accessible to the trial team for randomisation. Although tranexamic acid is heat stable, it will be stored in a dry place where it is protected from excessive heat and freezing. The expiry date of the trial treatment will be printed on the ampoule label, the treatment pack and the drug box. When a batch of treatment packs is close to expiry, the principal investigator (PI)/trial pharmacist/delegate will be asked to arrange the destruction of affected packs and record this on a Drug Destruction Form (DDF). When a site is to be closed, the PI/trial pharmacist/delegate will arrange the destruction of all unused packs and return a completed DDF to the LSHTM CTU Global Health Trials Group to confirm disposal.