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

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Overall withdrawal rate and level of withdrawal summarising those patients who have withdrawn from treatment but are still in follow-up and those who withdraw with no future contact.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)