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
- 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