HS&DR Study Steering Committee (SSC)/Trial Steering Committee (TSC) and Data Monitoring and Ethics Committee (DMEC) Checklist

This checklist is designed to be a useful aid to deciding whether you need to form a SSC/TSC and DMEC. The role of the SSC/TSC is to provide overall supervision for a project on behalf of the Project Sponsor and Project Funder and to ensure that the project is conducted to the rigorous standards set out in the Department of Health’s Research Governance Framework for Health and Social Care and the Guidelines for Good Clinical Practice. The formation of a DMEC is needed when there are particular risk factors involved in a study. A DMEC generally consists of 3 to 4 completely independent members and would have access to all necessary study data. For full guidelines on SSC/TSC and DMEC please refer to the full SSC Guidance (link) document.

Question / Yes/No / Comments / Notes
SSC
Is the cost of the project £400k or over? / If over £400k a programme appointed SSC/TSC is required
Is the project duration 30 months or over? / If 30 months or over a programme appointed SSC/TSC is required
Is the project an RCT? / If RCT (or pilot RCT) a programme appointed SSC/TSC is required
Does the project have multiple case study sites, is CI working less than 10% FTE, is the sample group made up of vulnerable people? / A complex study like this would need an SSC
If a programme appointed SSC is required:
Is the Chair fully independent*? / See notes on independence below
Is there a minimum of 75% independent* members? / See notes on independence below
Will the SSC require an independent* statistician? / A statistician is required if it is a full RCT or other complex study design in a study meeting the baseline criteria for a programme appointed SSC (cost / duration etc)
Will the SSC require an independent* health economist? / A health economist is required if there is a cost effectiveness or economic modelling element to a study meeting the baseline criteria for a programme appointed SSC (cost / duration etc)
Is there a PPI member? / Ideally, there should be at least one PPI member
Does the SSC membership comply with any Board recommendations? / The Board might make suggestions as to the SSC membership and these will need consideration if relevant
DMEC
Is the project using an investigational medicinal product (IMP) or medical device? / If ‘yes’ a DMEC is required
Is the project potentially open to ethical challenge? / If ‘yes’ a DMEC is required
The requirement for analysis of data, the detail of which should not be made available to the project advisory group or Chief Investigator / If ‘yes’ a DMEC is required
If a DMEC is required:
Are all DMEC members independent (with at least one member being UK based and/or holding a substantive UK based appointment)? / See notes on independence below
Have the Chair and members signed a log of potential conflicts? / This is a requirement of the DMEC

*Independence

The definition of independent is as follows:

• Not part of the same institution as any of the applicants or members of the project team

• Not part of the same institution that is acting as a recruitment or investigative centre

• Not related to any of the applicants or members of the project team

• For the chair only – not an applicant on a rival proposal