Clinical Trial & Observational Study Agreement Sign Off

The Sign off of Clinical Trials and Studies is managed by Dr Sadhbh O’Neill

Ms Colette Hoare, the Clinical Trials and Studies Officer is the first line of contact for agreement sign off  - Colette.Hoare@tuh.ie, 01-414 3049

The following documents are required to be reviewed by the Clinical Trials and Studies Officer:

  • Research Registration number - Registration Form
  • Clinical Trial Agreement /Research Collaboration Agreement for review by the Clinical Trials and Studies 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 Form – Print submission and send to the Clinical Trials and Studies Officer)
  • Sponsor Insurance

Please Note: 

  1. Deputy CEO must be the last signature on the contract documentation when all the documents as outlined above are approved for sign off by the Clinical Trials and Studies Officer
  2. 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 
  3. The Principal Investigator must approve the budget
  4. 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