This involved distributing the questionnaire via an email link to all trial managers and clinical trial recruiters engaged in paediatric and neonatal emergency care trials through identified gatekeepers in each of the 42 UK clinical trial units and eight Medicines for Children Research Network (MCRN) Local Research Networks LRNN).
The Trial Management Group will include a Trial Manager, Trial Programmer, Database Manager and Trial Statistician.
Access to the database will be overseen by the CTU data manager and trial manager.
Group allocation is revealed to the participant, trial manager and trial therapists.
The TSC will consist of an independent chair, two independent clinicians, independent consumer representative, the chief investigator, co-investigator, senior trial manager, trial manager and trial statistician.
The principal investigator, study manager and trial statistician will have access to the final data set.
The initial report can be made by secure fax which will also generate an email copy to the chief investigator, senior trial manager and trial manager.
Over the past 10 years, the original partnership of clinician and statistician for the running of clinical research projects, especially clinical trials, has come to be supplemented by the data manager and trial coordinator.
The Chief Investigator and the Trial Statistician, who will provide reports, the Trial Manager and the Trial Statistician will be in attendance.
3. Trial Steering Committee (TSC): The TSC will be chaired by an independent expert and members will include experts in Eating Disorders and General Psychiatry (different from those in the iDMC) as well as user and carer representatives, a lead trust representative and the Chief Investigator, who will provide a report, the Trial Manager and the Trial Statistician.
