Sponsorship Application

Once all of the required document shave been emailed to sponsor@ljmu.ac.uk the research governance manager will review the sponsorship application.

Comments on the documentation and any additional questions generated by the Sponsor Risk Assessment and/or Sponsor Review Checklist will be sent to the CI, and where relevant the study team, for comment and document revision as appropriate.

A response to each question, revised documentation and any points of clarification will be required before a further review is conducted by the Research Governance Manager. Only when all queries, required amendments, and points of clarification have been satisfied will LJMU confirm Sponsorship thereby giving authorisation to the CI to progress applications to Regulatory Agencies e.g. MHRA, HRA, REC, NHS Trusts etc.

The CI should allow 15 working days for Sponsor Review. If documents are resubmitted in response to deferral comments, the CI should allow 10 working days for the LJMU Research Governance Manager to further review the documents.

The Sponsorship Approval Letter is not the confirmation to set-up the study or commence recruitment. The Sponsor will only issue a letter to commence the study once all research governance checks have been completed for that study.

The Sponsorship Approval letter will contain a Sponsorship agreement detailing the roles and responsibilities of the CI and will detail the documentation required in order for the Clinical Research Governance checks to be completed and for the sponsor to provide permission for the study to commence. This includes requirements for: 

  • Regulatory approvals (HRA, NHS REC etc.)
  • Sign-off of all contracts and agreements
  • NHS sites capacity and capability

Once sponsorship approval in principle has been confirmed, investigators can book their research in for review by telephoning the HRA Central Booking Service.

Please note:
Investigators must not book their research in for review before sponsor approval in principle has been confirmed.

Sponsor Permission to Proceed

Prior to officially opening a research study for the recruitment of participants, the study must comply with all the relevant regulations, ethical guidelines and have appropriate Standard Operating Procedures in place and contracts/agreements in place. The Sponsor Permission to Proceed process ensures that all studies sponsored by LJMU have the required approvals, contracts, documentation and processes in place prior to opening.

The LJMU Research Governance Manager will check that each section of the Sponsor Permission to Proceed checklist has been completed and confirm that the study can proceed dependent on the required approvals, contracts, documentation and processes being in place prior to the study opening. A Sponsor Permission to Proceed Notification will be issued to the CI.

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