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Table 2 Suggested template for Trial Steering Committee (TSC) meeting agendas and reports

From: Exploring the role and function of trial steering committees: results of an expert panel meeting

1. Title of trial
2. Funding source(s) and Grant No.
3. Sample size sought
4. Protocol amendments and sub-studies
5. Summary of the data monitoring committee (DMC) recommendations
6. Date recruitment started
7. Proposed date for recruitment end
8. Actual recruitment rate versus target rate (by month/quarter)
9. Acceptance rate as a proportion of the following:
  i) those invited to participate, and
  ii) if known, all eligible participants
10. Percentage of participants proceeding through each trial stage to allow monitoring of the recruitment and retention, including missing outcome data. Not split by treatment/intervention arms.
11. Quarterly/monthly forecasts of recruitment for the planned remainder of the trial
12. Losses to follow-up as follows:
  i) as a proportion of those entered, and
  ii) per month/quarter
13. Data management metrics: rate of returns, volume of queries, time to return, enhanced metrics via electronic data capture
14. Number for whom follow-up has been completed successfully (or still being successfully followed-up)
15. Overall withdrawal rate and level of withdrawal summarising those patients who have withdrawn from treatment but are still in follow-up and those who withdraw with no future contact.
16. Summary of adherence to treatment/intervention. Not split by treatment/intervention arms.
17. Summary of adverse events including type, for example, adverse events, serious adverse events and suspected unexpected serious adverse reactions
18. Completeness of data collected
19. Any available results (pooled)
20. Summary of protocol deviations overall and by site
21. Any organisational problems or other trial issues
22. Issues specific to individual trials (to be specified by the Steering Committee)