Clinical Research Network; North West Coast Launch Local Portfolio Restart Framework

Clinical Research Network; North West Coast Launch Local Portfolio Restart Framework

As the restart of paused National Institute of Health Research (NIHR) research starts to get underway, Clinical Research Network; North West Coast (CRN NWC) would like support our Partner Organisations. Organisations will be at different stages in resuming their clinical services so will therefore have different time frames when looking at which studies that they are able to restart within their organisations. A Restart Framework has been published to guide the restarting of NIHR in healthcare, social care and public health settings.

The Clinical Research Network can help with the following:

• Liaise with Sponsor/Study Team/Chief Investigator/Lead Clinical Research Network/Clinical Research Network Coordinating Centre on your behalf to see if studies that you would like to restart meet all the pre conditions for Restart.

These pre-conditions are as follows:

• Viable
• Safety
• Capacity and site readiness

Once the above pre-conditions for restarting a paused study or starting a new study have been met the study can proceed, however, resource, capacity or other constraints may necessitate prioritisation of NIHR-funded support, including the workforce in NIHR CRN.

There are 3 levels of support within the framework, they are as follows:

Level 1: Essential studies providing evidence for pandemic management, i.e. prioritised COVID-19 Urgent Public Health (UPH) Research studies.

Level 2: Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.

Level 3: All other studies (including new COVID-19 studies not in Level 1)

Refresh for Restart

LCRNs have been completing a weekly review of Partners capacity and capability statuses and activity statuses of studies since the start of the Urgent Public Health Process. This has been really valuable in helping to understand the changes in the portfolio. Now that the Restart Framework is being implemented, we would like to use the same process to help monitor progress towards restoring a fully active CRN NWC research portfolio.

CRN NW Coast Local Portfolio Restart Framework

Currently, the Research Delivery Managers (RDMs)/Portfolio Research Facilitators (PRFs) of each Lead LCRN has been working with their local study Sponsors/Chief Investigators (CI)/Study Teams/Lead Sites/Specialty Research Leads (SRLs)/CRN Coordinating Centre (CRN CC) to ascertain the overall status of each of their non-commercial studies in order to see which paused non-commercial studies can be re-started ensuring pre-conditions are met. In the case of commercial studies this role is being fulfilled by the CRN Coordination Centre who are liaising with commercial sponsors and relaying this information to LCRNs via the Industry Delivery Lead and IFs. The PRFs/IFs will then facilitate this by relaying this information to participating sites and updating CPMS. This information is available upon request in order to support your local portfolio restart.

Studies where CRN NWC sites are participating

In order to aid the local study/site level restart, it is important that partners keep the data in Edge as complete and up-to-date as possible. There is also a requirement for partners to liaise with the CRN NWC core team in order to facilitate restart. The appropriate mechanism for this is via each partners assigned Senior Team Link (STL) and by including the STL/PRF/IF in your local Site Assessment and Prioritisation panel. This will ensure that CRN NWC has a complete picture regarding the proportion of the portfolio that is restarting in the region, site capacity, where we need to respond as a network to provide additional support and the impact the prioritising UPH studies will have.

Please note there is a national requirement for LCRN’s to be able to feedback this information centrally to understand the national picture.