Table 3 Summary of documentation that should be made available to the Trial Steering Committee (TSC) for approval or information
From: Exploring the role and function of trial steering committees: results of an expert panel meeting
| Document | Documents that require TSC approval | Documents that should be made to be available to the TSC but do not require approval | Timing of when document should be approved/made available |
|---|---|---|---|
| Trial Protocol | ✓ | Prior to trial opening and then available at all future trial meetings. Must be agreed on by TSC independent member as condition of TSC membership, but formal sign off of the protocol is not required. | |
| Statistical Analysis Plan (if an independent statistician is a member of the TSC then consider an independent blind review of the statistical analysis plan) | ✓ | Approved prior to implementation and then made available on request at future meetings. | |
| Sub-study proposals/protocols | ✓ | To be approved prior to submission for regulatory and REC approval if possible. | |
| TSC terms of reference | ✓ | Prior to or at the first TSC meeting. | |
| Protocol amendments –major/substantial amendment | ✓ | Prior to submission of the amendment to the Research Ethics Committee. | |
| Protocol amendments –minor/non-substantial amendment | ✓ | Throughout the trial, as they arise or as part of the next scheduled meeting. | |
| Trial publicity/promotion plan | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| Data sharing agreement if in place | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| Monitoring plan – to include information of the monitoring of data quality | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| DMC report plan | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| Open DMC report | ✓ | As a minimum, at the next TSC meeting following the DMC at which the report was presented or as agreed with the TSC if meeting frequency means that there will be as substantial delay in the TSC receiving this information. | |
| Risk Assessment | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| Publication policy | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| Main trial publications | ✓ | Prior to submission | |
| Participant information sheet and consent form (important for TSC to review consent form and what participants are providing consent for) | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| CRFs/questionnaires/data collection tools | ✓ | As a minimum, at the next TSC meeting following document approval by the TMG. | |
| DMC charter | ✓ | As a minimum, at the next TSC meeting following document approval by the DMC. |