Statutory Requirements

Statutory Requirements

A trial cannot begin until all the relevant permissions and approvals have been obtained.

Clear evidence of the documents submitted and the documents that were approved need to be retained in the Trial Master File.

Once proof of funding is in place, application can be made for sponsorship approval.

For Clinical Trials of Investigational Medicinal Products (CTIMPS) and High Risk Studies:

  • Research Governance carries out an initial risk assessment, agrees it with the Investigator, and study is sent to the Clinical Studies Oversight Group for full risk assessment and confirmation of sponsorship arrangements
  • Research Governance notifies the Investigator when sponsorship approved (including insurance cover)
  • Investigator sends IRAS forms to MHRA, REC and R & D and any other required regulatory body
  • Investigator send copies of ALL responses to Research Governance
  • Sponsor (green light) approval is given when ALL approvals are in place

Diagram illustrating order of stages in planning research: 1: Study design; 2: Facilities; 3: Scientific Peer Review; 4: Secure Funding; 5: Prepare study documentation; 6: Sponsorship; 7: Protocol; 8: Contracts; 9: Registration on public database; 10: Finalise study documents; 11: Statutory approvals; 12: Ethics review; 13: Initiation of study