FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ACADEMIC CLINICAL STUDIES SINCE THE IMPOSED MEASURES BECAUSE OF COVID-19 WERE ADJUSTED
After the communication of the chief physician of Ghent University Hospital about clinical studies during the COVID-19 pandemic (dd. 19MAR2020), non-priority consultations and treatments were suspended, no new patients were recruited/included and no new studies were initiated at Ghent University Hospital.
In reference to his latest communication regarding this matter (dd. 28APR2020), the chief physician clearly stated the following:
New clinical studies: Since the start of the crisis, you could only initiate new studies on the prevention, diagnosis or treatment of COVID-19. From May 4th, you can also initiate other clinical studies, in consultation with HIRUZ.
Arrangement for companies: Visitors from companies (representatives, monitors, auditors, CRA) may only come to the hospital if this is necessary for patient care. That arrangement has been extended until May 18th.
Addition from the chief physician (dd. 13MAY2020): From Monday May 18th on, in case contact by telephone or digital contact is deemed insufficient, visitors from companies (representatives, monitors, auditors, CRA) may come to the hospital again. Visitors have to follow the guidelines concerning distance and hand hygiene.
With regard to these guidelines, we received many questions from investigators about their academic trials and the actions to be taken. The most frequently asked questions are summarized in the following document: FAQ about academic studies during the COVID-19 pandemic (version 2.1 dd. 14MAY2020). Please carefully follow the guidelines described in this document.
Please note this new version of the FAQs replaces the previous version(s) entirely.
The HIRUZ Clinical Trial Unit (CTU) is recognized for its expertise in the support and advice in submissions and monitoring of academic clinical research projects. Investigator-initiated academic clinical research is defined as research for which a (university) hospital, university or an authorized organization acts as sponsor. This means that this particular institution has the full responsibility over the design, set-up, management and safety of the clinical experiment. In addition, the sponsor owns the study results and has the right to publish them freely. The definition of investigator-initiated research does not exclude that the institution receives support in order to execute the study (e.g. financial support, free medication, statistical support, CRF creation, personnel…).
- Support in the preparation of a correct and complete submission package for the Ethics Committee and Competent Authority, if applicable
- Guiding the investigator in reporting to the Ethics Committee and/or the Competent Authority: amendments, safety reporting, annual progress report, end of study reporting, notifications,…
- Performing on-site and remote monitoring according ICH-GCP for all clinical trials with medical products and medical devices for which Ghent University (Hospital) is sponsor. Monitoring can also be provided for other trials upon request,
- Providing a no-fault insurance (only when Ghent University (Hospital) is sponsor),
- Guiding investigators and providing advice in the development of a trial,
- Providing (online) training regarding ICH-GCP
- Follow-up on the new or updated regulations, interact with other research institutions (universities, university colleges, VIB, Government, KCE…)
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
Clinical Trial Unit Manager: Dr. Philippe Van Rompaey
Before setting-up your trial, please contact HIRUZ.CTU@UZGent.be or +32 9 332 05 00
For agreement related questions, please contact HIRUZ.Contracten@UZGent.be
For study related questions, please contact your focus team