Clinical Trial, Studies Contract Review & Execution

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The review and execution of Clinical Trials & Studies contracts is managed by Dr. Sadhbh O’Neill Scanlon (Sadhbh.oneill@tuh.ie).

Ms. Deirdre O’Brien, the Clinical Trials and Studies Contracts Officer is the first line of contact for contract review and execution.

Deirdre is available from Tues to Fri 9:30am – 3:30pm at deirdre.obrien02@tuh.ie or (01) 414 2952.

Clinical Trial Documentation
The following documents are required to be reviewed for a Clinical Trial:

  • Sponsor DPIA or Sponsor Statement of Compliance to accompany the TUH Data Protection Compliance Form
  • Clinical Trial Agreement (CTA) / Contract / Research Collaboration Agreement               
  • The sponsor, or legal representative of the sponsor must be established within the European Economic Area
  • Including Financial Appendix / Budget
  • Budget should include CTA/DPA Review Fee of €3,000
  • Data Protection Agreement (DPA) - Can be a section in the contract, appendix or standalone document
  • Site Specific Assessment (SSA) or Site Specific Template (SST). Must be signed and dated by Principal Investigator
  • Clinical Trial Indemnity Form - State Claims Agency template, Version 4 to be used
  • Research Ethics Committee favourable opinion, CTIS Approval Part 1. Must list TUH as a site and TUH Principal Investigator name
  • HPRA granted Authorisation for Clinical Trial – CTIS Part 2 approval
  • Sponsor Insurance Certificate
  • The following documents may also be requested:
    • Letter of Authorisation/delegation of Authority
    • Standard Contractual Clauses (SCCs)
    • Transfer Impact Assessment (TIA)
    • HRCDC Approval

The following documents are required to be reviewed for an Observational Study:

  • Data Protection Impact Assessment (DPIA) – Section 4 of the SJH/TUH JREC Application form
  • Observational Study Agreement / Contract
  • The sponsor, or legal representative of the sponsor must be established within the European Economic Area
  • Including Financial Appendix / Budget, if applicable
  • Data Protection Agreement (DPA). Can be a section in the contract, appendix or standalone document
  • Research Ethics Committee favourable opinion. Must list TUH as a site and TUH Principal Investigator name.
  • The following documents may also be requested:
    • HPRA granted Authorisation for Clinical Trial
    • Sponsor Insurance Certificate
    • Letter of Authorisation/delegation of Authority
    • Standard Contractual Clauses (SCCs)
    • Transfer Impact Assessment (TIA)
    • HRCDC Approval

When this documentation is reviewed and agreed, we make a submission to AON for approval through the Clinical Indemnity Scheme. On receipt of this final approval we can proceed to signing the contract.

Please Note: 

  1. The CEO must be the final signature on the contract after all the documents outlined above are approved for sign off by the Clinical Trials and Studies Contracts Officer
  2. The Adelaide and Meath Hospital, Dublin, incorporating The National Children's Hospital is the legal name for TUH and must be used on all documentation
  3. The Principal Investigator, Pharmacy, CRF CNMII, Radiology and other stakeholder departments within TUH must approve the budget
  4. Where the Pharmacy Department (pharmacy.clinicaltrials@tuh.ie) are involved in the trial they must approve the pharmacy budget.  This approval must be sent to the Clinical Trial and Studies Contracts Office