East Kent Hospitals University NHS Foundation Trust’s Restart documentation
East Kent Hospitals University NHS Foundation Trust’s Restart process included the introduction of a checklist which was adapted from the NIHR Restart Framework.
The Framework was tweaked to fit the trust’s needs. The checklist covered everything from capacity and capability, to making sure all the documents were up to date in R&I.
Alongside this checklist, R&I developed a two-page Restart Pro Forma for each team leader to complete for each study. The main part of the Pro Forma looks at viability and what measures need to be put in place to ensure the study can be opened safely. Capacity, site readiness, and local prioritisation is also assessed at this stage.
Team leaders then contact each of the support departments and tick the box to say they've been contacted, and the date that they agreed that they could carry on.
Once the Pro Forma is completed it is sent to the R&I Manager for review and a second approval. If the R&I Manager has concerns or queries they will go back to the team leaders. If there are no queries the Pro Forma is signed off.
Some studies do not fit into the Restart Pro Forma, for example, some simple registry studies do not have one because they are data collection studies. However, the majority of studies will have a Restart Pro Forma.
Once the teams started working with the Pro Forma it became clear that certain studies could not open at the time as services were not available, for example, outpatient appointments were not taking place. The Pro Forma benefited the team in highlighting these issues.
When the R&I team was pausing all the studies in March they created one spreadsheet covering each of the three sites to detail the paused studies. A new tab has been added to cover Restart. Once the studies were in the Restart process, they were put under the Restart tab. Once the study has been activated they are put under the ‘action/activated’ tab i.e the study is open and running again.
If the trust or sponsor decided that a lot of work needed to be done to a study to open, it would be discussed at the weekly COVID-19/Restart meeting. There would be discussions on whether to pursue the study at this time, or whether it is kept on pause for the time being and another study could potentially be opened instead.