Clinical Trials Checklist

Below is a helpful guide produced by the MRC. MRC Controlled Trials: Trials Outline Form. This may be beneficial to researchers and/or chief investigators when developing trial idea(s).

1. Trial identifier

  • Full title of trial
  • Acronym
  • Principal applicant
    Name, affiliation, address, telephone, fax, email

2. The need for a trial

  • The problem to be addressed
  • Principal research questions
  • Why is the trial needed now? (Evidence)
  • References to any systematic reviews and discuss the need for the trial in the light of the reviews
  • Details of other relevant trials currently underway (UK and international)
  • How will the results of the trial be used?

3. The proposed trial

  • Trial design, e.g. double blind RCT, case-control study
  • Planned trial interventions
  • Arrangements for allocating participants to trial groups
  • Methods for protecting against sources of bias, e.g. masking or blinding
  • Inclusion/exclusion criteria
  • Duration of treatment period
  • Frequency and duration of follow-up
  • Outcome measures (primary and secondary)
  • How will the outcome measures be measured at follow-up?
  • Sample size
  • Recruitment rate
  • Any likely problems with compliance?
  • Likely rate of loss to follow-up
  • How many centres will be involved?
  • Details of analysis, including any sub-group analysis and the frequency of analysis
  • Will any economic issues be addressed?
  • Estimated research cost
  • NHS cost implications
  • Funding period
  • Is there a planned pilot feasibility stage?

4. Details of trial team

  • Trial management
    Details of those responsible for running the trial, including name, affiliation, area of expertise and role.
  • Participating centres