Clinical Trial & Observational Study Agreement Sign Off

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

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

Deirdre is available from Tues to Fri 09:30 – 15:30 at deirdre.obrien02@tuh.ie or (01) 414 2952

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

  • Data Protection Impact Assessment (DPIA)
    • TUH DPIA Template
    • Sponsor DPIA and TUH DP Compliance Form
    • Sponsor Statement of Compliance and TUH DP 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 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
    • Must list TUH as a site and TUH Principal Investigator name.
  • HPRA granted Authorisation for Clinical Trial
  • 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)
  • 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 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 Deputy 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 must approve the budget
  4. Where the Pharmacy Department are involved in the trial they must approve the pharmacy budget pharmacy.clinicaltrials@tuh.ie. This approval must be sent to the Clinical Trial and Studies Contracts Officer

Online Portal

All documentation listed above must be submitted to our online submission portal https://sjh-tuh.forms.ethicalreviewmanager.com/

1. Steps to create an account: (Please use the Chrome browser to access the portal)

  • To begin, click on the link above and click 'ok'.
  • Click on the white ‘Log in’ button in the top right hand corner.
  • Click on the green ‘New User’ button.
  • Complete the registration form including your email address and new chosen password.

Passwords must be 10+ characters long but no longer than 64, contain both upper and lower case characters and contain at least one special character and one number *

  • Click to agree to T&Cs and click the blue ‘Register’ button.
  • An email will then be sent to you to verify your identity. Click on the link in your email to activate your account.
  • Login using your email address and password.

2. For Ethics Submission:

  • You will need to log in and use the Main Application form – see SJH/TUH Joint Research Ethics Committee tab

3. For Contract Submission:

  • You will need to log in and click ‘Create Project’ in the upper left hand corner.
  • Type the name of the clinical trial in the Project Title* box.
  • From the Form* drop down box select ‘Contracts – Clinical Trials and Studies’.
  • From the Centre* drop down box select ‘Ethics Committee – SJH/TUH’ (This does not mean you’re applying for Ethics Approval, you just need to choose one for the system proceed).
  • You can then use the tabs to upload the documentation.