Setting up a clinical study

Setting up a clinical study at our university hospital and faculty follows the same path: finding the right expert, agreeing a budget, submitting the application through the Research Portal for review and approval, and finalizing the contract once approved. The sections below walk you through each of these steps, both for academic and commercial studies.

• Contact the relevant clinical departments (study groups) directly. If you cannot identify the right expert, our contact form can help connect you with the right person.
• Sign a non-disclosure agreement (NDA) with the expert of your choice to protect shared information.
• Verify the feasibility of your study or arrange an on-site visit with your team of experts. More information on scheduling visits is available on each clinical departments’ website. 

• Budgets depend on whether a study is academic or commercial, and on who the study sponsor is – more information is available on the HIRUZ website.
• Final study documents (such as the protocol and laboratory manual) form the basis for budget negotiations. Note that each new version of these documents may lead to a revised budget or require a contract amendment. 
• Budgets are negotiated separately with each clinical trials department involved.
• For invoicing, include the contract reference number (KW number) in all related communication.

• Types of contracts
  • The type of agreement used depends on the nature of the collaboration. Visit the HIRUZ website for an overview of the available contract types.
• Drafting and assessment of contracts
  • When a study is registered in the Research Portal, a notification automatically indicates that a contract is required.
  • The sponsor of the clinical trial typically leads the drafting of the initial proposal, negotiates with the relevant parties, finalizes the contract and collects signatures.
  • For the exchange of human biological material or research data, the data or material custodian leads the contract drafting.
  • Ethics applications and contract drafting can, in principle, proceed in parallel, though in practice contracts are usually finalized after ethical approval, once the study protocol is definitive. Contracts for the exchange of human biological material or data are always finalized after ethical approval.
• Contract reference number
  • Each contract receives a unique reference number (KW number), used in all related communication.
• Signing of contracts
  • Depending on the agreement type, research and service agreements may be signed by (medical) department heads, either digitally or, where required, on paper.
    Visit the HIRUZ website for practical procedures and further information.

• The UZ Gent Clinical Trial Teams site offers centralized access to general and department-specific documentation, including:
  • Department-specific documents for each clinical research department (protocols, GCPs, laboratory reference values, temperature logs and other standardized documents)
  • Generic resources, such as the organization ID, location ID and electronic medical record questionnaire, available under "0. UZ Gent General"
• Requesting access to the Teams site 
  • Access can be requested via the Research Portal: select the department of the principal investigator you're working with, and provide the names and email addresses of those in your organization who need access.
  • Once the relevant department approves the request, you'll receive an email granting read-only access.
  • Access remains valid for one year and is reviewed annually. If no response is received, or access is no longer needed, it will expire. Access can then be requested via a new request at the Research Portal.

• The type of research you intend to conduct should be determined first. Visit the HIRUZ website for more information.  
• All applications need to be submitted via the Research Portal. 
  • What can you find on the research portal?
  • How do you access the research portal?
• For studies requiring a local application, approval from the Ethics Committee of U(Z)Gent or the Data Access Committee of UZ Gent may be necessary. The Research Portal will automatically forward your submitted application to the appropriate committee.
  • What is the legal timeframe for receiving advice from the Ethics Committee (EC) and the Federal Agency for Medicines and Health Products (FAGG)?
• Once approved, you need to update the study's active status via the Research Portal (study lifecycle).

• All processing of personal data in scientific research must be recorded in a register of processing activities. This is required for every new research project and every amendment, and must be submitted with your ethics committee application. 
• Registration can be completed via DMPonline.be, alongside or separately from a Data Management Plan (DMP):
  • With a DMP (e.g. for an external funder): use a GDPR-compliant DMP template to register your processing activities at the same time.
  • Without a DMP: use the UGent/UZ Gent "GDPR Record" (English) or "AVG Register" (Dutch) template.
• Creating your register
  • Log in to DMPonline.be with your UGent or UZ Gent account and click "Create Plan."
  • Enter your project title, select your organization ("Ghent University" or "no research organization"), and select a funder if applicable.
  • Choose your template ("AVG Register (NL)" or "GDPR Record (EN)") and click "Create Plan."
  • Complete the "Plan details" (you're listed as Principal Investigator by default — adjust this via "Add/Remove collaborators" if needed) and the mandatory GDPR questions under the "GDPR Record" tab.
  • If your research involves a likely high data protection risk, also complete the "DPIA" tab.
• Data Protection Officer
  • The DPO (UZ Gent: dpo@uzgent.be / UGent: privacy@ugent.be) can be given access to your plan via the "Share" tab. It is recommend to also email them directly, as access is not automatically flagged.
• Exporting and updating
  • Plans can be exported as .docx, .pdf or .txt – a PDF export of the GDPR Record is required for medical ethics committee review. Keep your register up to date throughout your project via the "View plans" menu.

• External parties requiring system access, badges or access passes for monitoring purposes need to be registered through the contractor portal, submitted by a UZ Gent employee – ideally from the department the external contractor is working with.  

• Once a study concludes, an end-of-trial report is submitted via HIRUZ.
• All study documents are archived in accordance with legal requirements.

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