Glossary

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • 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.
  • Delegation Log

    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 blind

    A trial where the investigators and the subjects included in the trial (healthy volunteers or patients) do not know which interventions / treatments have been assigned.