Trial Management Group (TMG)
The Trial Management Group normally includes those individuals responsible for the day-to-day management of the trial, such as the Chief Investigator, statistician, trial manager, research nurse, data manager. The role of the group is to monitor all aspects of the conduct and progress of the trial, ensure that the protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself.
Trial Master File (TMF)
The Trial Master File contains all essential documents held by the sponsor/Chief Investigator which individually and collectively permits the evaluation of the conduct of a trial and the quality of the data produced.
A hospital, health centre, surgery or other establishment or facility in the UK at or from which a CTIMP, or any part of a CTIMP, is conducted.
Trial Steering Committee (TSC)
The role of the Trial Steering Committee (TSC) is to provide the overall supervision of the trial. Ideally, the TSC should include members who are independent of the investigators, their employing organisations, funders and sponsors. The TSC should monitor trial progress and conduct and advise on scientific credibility. The TSC will consider and act, as appropriate, upon the recommendations of the Data Monitoring Committee (DMC) or equivalent and ultimately carries the responsibility for deciding whether a trial needs to be stopped on grounds of safety or efficacy.
See MRC Guidelines for GCP for Clinical Trials 1998 for terms of reference and further guidance (Appendix 3).
Type A Trial
Trials involving medicinal products licensed in any EU Member State if:
- they relate to the licensed range of indications, dosage and form; or
- they involve off-label use (such as in paediatrics and in oncology etc.) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.