The Sign off of Clinical Trials and Studies is managed by Dr Sadhbh O’Neill (Maternity Leave cover – Ms Chita Murray)
Ms Colette Hoare, the Clinical Trials and Studies Officer is the first line of contact for agreement sign off - Colette.Hoare@tuh.ie, 01-141 3049
The following documents are required to be reviewed by the Clinical Trials officer:
- Research Registration number - Registration From
- Clinical Trial Agreement /Research Collaboration Agreement for review by the Clinical Trials Officer. (The sponsor, or legal representative of the sponsor must be established within the European Economic Area )
- Data Protection Agreement as appendix to main agreement
- Research Ethics Committee favourable opinion listing TUH as a site.
- HSE Clinical Trial Indemnity Form (State Claims Agency template to be used – DO NOT AMEND)
- HPRA granted Authorisation for Clinical Trial or Clinical Investigation, if applicable
- SSA (Site specific Assessment) signed and dated by PI.
- Data Protection Impact Assessment (Registration From – Print submission and send to the Clinical Trials and Studies Officer)
- Sponsor Insurance
- The DCEO must be the last signature on the contract documentation when all the documents as outlined below are approved for sign off by the Clinical Trials and Studies Officer
- The Adelaide and Meath Hospital Dublin, incorporating The National Children's Hospital (AMNCH) is the legal name for TUH and must be used on all documentation
- The Principal Investigator must approve the budget
- Where the Pharmacy Department are involved in the trial they must approve the Pharmacy budget. Please contact the clinical Trials Pharmacist, Riona.Tumelty@tuh.ie for further information