As soon as your trial is submitted to our Clinical Trial Unit, the need for a Clinical Trial Agreement or another type of scientific collaboration agreement is evaluated. All contracts will be reviewed internally. Our Contract Unit shall decide if your contract proposal is according to our legal standards. Agreements that deviate from the standard wording will be transferred to and further handled by the Ghent University Hospital Legal Department.Examples of investigator-initiated research agreements are:
- Standard intersite or intercountry agreements (between academic institutions)
- Research funding agreements (grants, study product funding…)
- Data or material transfer agreements
Contracts/agreements with external commercial partners have to be submitted to our Clinical Trial Unit (HIRUZ.Contracten@UZGent.be). If needed (in preparation for an initial application), advice on guidelines/agreements can be requested.Examples of external commercial agreements are:
- Clinical Trial Agreements (CTA) / Service Agreements
- Material Transfer Agreements (MTA)
- Data Purchase / Transfer Agreements (DTA)
- Confidentiality Agreements (CDA) / Non-Disclosure Agreements (NDA)
- Consultancy Agreements (CSA) / Symposium / Speaker Agreements
- Donations / Grants
Application by e-mail: HIRUZ.Contracten@UZGent.be
The application is admissible when the following files are provided:
- Contract: to be provided as editable (track changes “on”) and unprotected Word file. Agreements in letter form or printed copies of (signed) scanned agreements will be regarded as inadmissible.
- Clinical Trial Agreements (CTA): besides the contract itself, the application also has to contain the following documents:
- A copy (and/or draft) of Doc A (Ethics Committee (EC) request form)
- The protocol (optional)
2. (P)review process
While processing/analyzing admissibility of the application, a (p)review based on internal guidelines will be performed at HIRUZ CTU.
Attention: budgets/fees need to be discussed with the involved department(s), i.e. PI/investigator(s)/study team(s).
The applicant (i.e. Sponsor, CRO, investigator and/or Study Nurse) will receive an e-mail sent by HIRUZ CTU. This e-mail will contain the BC-number, which is a unique reference number given to the study, file or agreement.Please keep in mind:
- To edit the original Word file with “track changes”
- Not to protect the document
- To not convert to pdf
- To return Sponsor’s/CRO’s feedback to HIRUZ CTU
When all parties involved (i.e. Sponsor, CRO or UZ Gent Departments) agree with both the legal content and the budgets, following guidelines need to be taken into account with regard to the finalization of the agreement:
- Budgets have to be approved by the involved Ghent University Hospital Department(s), prior to the start of the actual signing of the Agreement
- Agreements have to be finalized (in triplicate) as wet copies and signing starts at the Sponsor’s/CRO’s end
- When signed at Sponsor’s/CRO’s end, the Agreement can be sent to the Ghent University Hospital for counter signature
- Ghent University Hospital Executive Director (and the Government Official) are the last Parties to sign the Agreement (after Ghent University Hospital EC approval has been obtained).
Contract Unit Manager: Paulien Walraet
For general agreement related questions, please contact HIRUZ.Contracten@UZGent.be