Terms of reference

• The TSC should approve the protocol and trial documentation in a timely manner.
• In particular the TSC should concentrate on progress of the trial, adherence to the protocol, patient safety and consideration of new information of relevance to the research question.
• The safety and well-being of the trial participants are the most important consideration and should prevail over the interests of science and society.
• The TSC should provide advice, through its chair, to the chief investigator, the trial sponsor, the trial funder, on all appropriate aspects of the trial. Specifically, the TSC will:
  • Monitor recruitment rates and encourage the TMG to develop strategies to deal with any recruitment problems.
  • Monitor completion of data sheets and comment on strategies from TMG to encourage satisfactory completion in the future.
  • Monitor follow-up rates and review strategies from TMG to deal with problems including sites that deviate from the protocol.
  • Approve any amendments to the protocol, where appropriate.
  • Approve any proposals by the TMG concerning any change to the design of the trial, including additional sub-studies.
  • Oversee the timely reporting of trial results.
  • Approve and comment on the statistical analysis plan.
  • Approve and comment on the publication policy.
  • Approve and comment on the main trial manuscript.
  • Approve and comment on any abstracts and presentations of any results during the running of the trial.
  • Approve external or early internal requests for release of data or subsets of data or samples including clinical data and stored biological samples.
  • Receive reports from the DMEC.
  • The TSC will make decisions as to the future continuation (or otherwise) of the trial.
• Membership of the TSC should be limited and include an independent chair, at least two other independent members, two collaborators and two members of the public. The investigators and the trial project staff are ex officio.
• Representatives of the trial sponsor and the HTA should be invited to all TSC meetings.
• Responsibility for calling and organising the TSC meetings lies with the chief investigator. The TSC should meet at least annually, although there may be periods when more frequent meetings are necessary.
• There may be occasions when the trial sponsor or the HTA will wish to organise and administer these meetings in exceptional circumstances.
• The TSC will provide evidence to support any requests for extensions, including that all practicable steps have been taken to achieve targets.
• The TSC will maintain confidentiality of all trial information that is not already in the public domain.

Membership

Professor Michael Preece (chairperson) Consultant Paediatrician, Great Ormond Street Children’s Hospital

Mrs Pamela Barnes Lay member

Ms Sian Edwards Paediatric Pharmacist, Royal Brompton Hospital

Professor David Field Neonatologist, Leicester Royal Infirmary and the University of Leicester

Dr James Hooper Consultant Clinical Biochemist, Royal Brompton Hospital

Mrs Tara Quick Lay member, parent

Dr Claire Snowdon Lecturer, Medical Statistics Department, LSHTM, and Centre for Family Research, University of Cambridge (until 2011)

Ms Lyvonne Tume Research Nurse, Royal Liverpool Children’s Hospital

Dr Dirk Vlasselaers Consultant Paediatric Intensivist, Leuven, Belgium

Professor Paula Williamson Professor of Medical Statistics, University of Liverpool