The operational management group meets face-to-face on a regular basis to ensure the smooth day-to-day running of the project, adherence to the project timetable and adherence to the project budget. In addition, the group reviews recruitment rates at participating sites and addresses operational issues as they arise.
The Operational Management Group consists of Dr Ira Madan, Dr Vaughan Parsons, Dr Alison Wright, Ms Caroline Murphy, Ms Joanna Kelly, Mrs Beverly White- Alao, Mrs Barbara Smiley and Mr Daniel Weston. Other members of the research team are co-opted into individual meetings as required.
Trial Management Group (TMG):
The trial management group is responsible for overseeing the methodology of the trial, ensuring that the trial complies with ethical guidance, runs to budget and project timelines. The group consists of Dr Ira Madan, Professor Hywel Williams, Professor David Coggon, Professor Barry Cookson, Dr Alison Wright, Professor Paul McCrone, Ms Caroline Murphy and Dr Vaughan Parsons. The trial administrator also participates. The trial management group meets annually in London, and ad hoc as required, by teleconference during the project period.
Trial Steering Committee (TSC):
The trial steering committee provides overall supervision of the trial to ensure the requirements and standards outlined in the Medical Research Council-Guidelines for Good Practice for Clinical Trials 1988 are being met. These come under the headings: Patient safety; trial progress; adherence to study protocol; consideration of new information; dissemination and implementation of results; complaints procedure and compensation for participants. Since the trial will not be monitored by a data monitoring committee (as agreed with NIHR HTA, May 2013) a major role of the trial steering committee is advised on the implications of protocol changes, in particular the need to add more centres as either some drop out or insufficient nurses sign up to take part.
The trial steering committee meets face-to-face in London four times during the period of the study. The first face-to-face meeting took place in July 2014 after the feasibility study and prior to the commencement of the main trial.
The following members of the trial steering committee have been appointed by HTA: Dr Kit Harling CBE, a recent former senior OH advisor to the Department of Health ( Independent Chair) Professor Peter White (Psychiatrist and trialist), Wendy Taylor (patient representative), Dr Ira Madan (chief investigator), Dr Lesley Rushton (co-investigator), Dr Gopal Roa (Infection control specialist), Dr Graham Johnston ( dermatologist), Dr Isabel Reading (statistician and observer)