Data Monitoring Committee (DMC) (also known as DMEC, IDMC, DSMB and ISMC)A committee that may be established by the sponsor to assess at intervals, the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
A list of appropriately qualified persons to whom the investigator has delegated significant trial related duties. Sponsors/host organisations will usually provide a template for the Delegation Log and researchers should check with their NHS R&D office if any ‘preferred template’ is available. If no default document is available, the following delegation log template may be adapted.
Development Safety Update Report (DSUR)The common format for annual safety reports on investigational drugs in the ICH regions under ICH guideline E2F.
Doctors and Dentists Exemption (DDX)Pre-2004 Clinical Trial Arrangements: former method for the approval of a clinical trial by the MHRA now replaced by the Clinical Trial Authorisation.
Double blindA trial where the investigators and the subjects included in the trial (healthy volunteers or patients) do not know which interventions / treatments have been assigned.