Site set up and Sponsor Permission to Proceed

The CI is responsible for NHS site set up. For studies that include NHS research sites in England where the lead site is in England, once the CI receives the HRA Approval initial assessment letter (or HRA Approval letter in cases where no initial assessment letter is issued) they can contact participating NHS sites, the local study team (where there is one) to the Local Clinical Research Network (if the study is on the NIHR portfolio) to provide them with the 'local information pack' and finalise discussions around confirming capacity and capability.

The local information pack should contain:

  • Copy of IRAS Form as submitted for HRA Approval
  • Protocol and amendments
  • Participant information and consent documents
  • Relevant model agreement
  • Commercial studies only – NIHR Costing template (validated) and delegation log (including known research team names but not signatures)
  • Organisation Information Document (OID) for non-commercially sponsored projects – template and guidance
  • Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
  • Copy of HRA initial assessment letter (if one is issued) and (when issued) HRA Approval letter and final documents.

The HRA initial assessment or HRA Approval letter will provide information relevant to study set up including:

  • Working with participating NHS organisations
  • Which participating NHS organisations need to confirm capacity and capability
  • Training requirements
  • HR arrangements

Any cost negotiations that are required with the participating organisation can be finalised at this stage. The HRA initial assessment or HRA Approval letter will confirm whether all, or some types of, participating organisations are not required to formally confirm capacity and capability.

Where formal confirmation from all or some of the participating organisations is required the relevant NHS organisation will provide the CI with confirmation via email that all the arrangements have been put in place to deliver the study and indicate that they are ready to start the study. Where formal confirmation from all or some of the participating organisations is not required, the HRA initial assessment or HRA Approval letter will specify the timeline for these organisations to object or request more time to consider, following provision by the sponsor of the full local information pack.

LJMU Sponsor Permission to Proceed

Once the investigator has sent confirmation of regulatory approvals (e.g. HRA, NGHS REC etc.), sign-off of contracts and agreements (if applicable) and NHS sites capacity and Capability to sponsor@ljmu.ac.uk, investigators should allow at least 10 working days for the LJMU Sponsor Permission to Proceed notification to be issued or for further information to be requested. The Sponsor Permission to Proceed Notification will list the roles and responsibilities of the CI that must be adhered to once the study has opened. This includes:

  • Notify LJMU REG of the date of the first participant recruited into the study
  • Creation and maintenance of a Study Master file
  • Delegation at site
  • Study amendments
  • Annual reports
  • Safety reports
  • Standing operating procedures
  • International research
  • Auditing and oversight provision
  • End of study
  • Close out
  • Dissemination of study findings
  • Archiving

The LJMU Sponsor Permission to Proceed notification confirms that all sponsor requirements have been met and that the study may proceed to the next stage to open the study. If there is a no objection deadline in place participant recruitment can be initiated at an NHS site once NHS R&D office have confirmed via email to the CI that the study may proceed in advance of the no-objection deadline or the no-objection deadline has passed.

For further information please refer to SOP001 LJMU Research Sponsorship Application Process and SOP003 Roles and Responsibilities for LJMU Sponsored Research.