Early Adoption of the Plan and Manage Health and Care Research System

As early adopters, we as Sponsors have been granted early access to the system. This allows both Sponsor teams and investigators to begin using the new platform ahead of full national implementation. Early access provides:

• Additional support during the transition period
• Opportunities for Sponsors and investigators to provide feedback
• The ability to test new workflows before wider rollout

The system is being implemented in phased stages, with functionality released gradually. The rollout is expected to take place in stages, beginning with modifications to eligible existing non-CTIMP/non-regulated medical device studies. Current plans suggest that support for new non-CTIMP/ non-regulated medical device applications will follow during spring 2027, with new CTIMP/regulated device applications and modifications anticipated towards the end of 2027. As the programme evolves, these timings may change and we will keep investigators informed of any updates.

Early Phase Scope

During the initial rollout, the system will support a limited set of study activities. In the early phase, this includes:

• Submission of modifications for existing studies:
  • Where NHS REC review was not required, but
  • Local NHS R&D (capacity and capability) approval was required

This means investigators working on studies that fall into this category will begin using the new system for submitting modifications, while other study types will continue to use IRAS until later phases are released.

As further study types are included we will continue to update investigators.

When a suitable study is identified, the Sponsor representative for the study will be in touch to explain the new process.