1. Buy-in and agreement
Firstly, the scheme needs to be adopted and bought into by the research centre, organisation, study group or network and agreed as their chosen approach to quality management and monitoring. A key element of this ‘buy in’ is that specific time is made available for those selected by the study teams to be monitors. Here the significant benefits (as described above) need to be made clear. This needs to be agreed and negotiated very early and terms set out (template agreement available). This scheme might be required for one specific study in a multi-centre setting or might be being put into place within one research centre, or across a network as a long term solution and resource for their study monitoring.
2. Set up systems
Once agreed in principle the leading organisation/facility network needs to establish a management system for the scheme, and a coordinator is likely to be needed. Here the systems required will include the following
3. Training your monitors
Materials and suggestion for this will shortly be available on the REDe platform. Experience tracking, oversight and support are also key and resources are also available for this.
4. Implementing into studies
The suggested approach is that for every study a quality or monitoring plan is put into place and this will lead to the generation of a monitoring or quality management SOP. Studies should have a person allocated as their quality manager and this person should work with the reciprocal monitoring coordinator to appoint the monitors for new research studies. The coordinator drafts a periodic schedule detailing which research studies are to be monitored within that period. The frequency of monitoring for each study is determined based on the complexity of the study, the extent of external monitoring and specific protocol requirements. This is clearly documented in the study specific monitoring plan, this plan should include details the report review process and how recommendations are implemented.