The Trial Steering Committee for the PROMED-EX intervention is chaired by Prof Emma Stevenson from Newcastle University.
The Committee members are:
Dr Claire McEvoy - Queen's University Belfast
Prof Jayne Woodside - Queen's University Belfast
Dr Chris Cardwell - Queen's University Belfast
Prof Lorraine Brennan - University College Dublin
Prof Lisette de Groot - Wageningen University
Prof Dorothee Volkert - Friedrich-Alexander-Universität Erlangen-Nürnberg
Ms Bernie Devlin - PPI group member
Ms Eleanor Butterwick - PPI group member
To act as the oversight body for PROMED-EX on behalf of the Sponsor/Funder.
The role of the TSC is to provide oversight for the trial [Medical Research Council (MRC) Good Clinical Practice (GCP) guidelines (1998)]. It should also provide advice through its independent Chairperson to the PI, local trial team, BBSRC on all aspects of the trial.
Specific Roles of TSC
- provide expert oversight of the trial
- maintain confidentiality of all trial information that is not already in the public domain
- make decisions as to the future continuation (or otherwise) of the trial/s
- monitor recruitment rates (reported using the Consolidated Standards of Reporting Trials (CONSORT) statement guidance for reporting Randomised Controlled Trials (RCTs) (Schulz KF et al, 2010)) and encourage the trial team to develop strategies to deal with any recruitment problems
- review regular reports of the trial from the trial team
- assess the impact and relevance of any accumulating external evidence (provided by the local trial team/trial manager)
- monitor completion of CRFs and comment on strategies from trial team to encourage satisfactory completion in the future
- monitor follow-up rates (reported by the Trial team using robust records collected throughout the study and reported using the CONSORT guidance for reporting RCTs (Schulz KF et al, 2010)) and review strategies from Trial team to deal with problems
- approve any amendments to the protocol, where appropriate
- approve any proposals by the Trial team concerning any change to the design and conduct of the trial, including additional substudies
- oversee the timely reporting of trial results
- comment on the main trial manuscript
- comment on any abstracts and presentations of any results during the running of the trial
The Committee meet twice a year and receive monthly progress reports on the PROMED-EX intervention.