FAST-TRACK PROCEDURE FOR ACADEMIC COVID-19 STUDIES
In reference to the communication of the chief physician of Ghent University Hospital (dd. 19MAR2020) about COVID-19 studies, he clearly states the following: “Studies on the prevention, diagnosis or treatment of COVID-19 can be initiated. Both HIRUZ and the Ethics Committee prioritize these dossiers following a fast-track procedure. However, this is not an exemption to initiate these studies quickly without the necessary documentation or any assurances regarding patient safety.”
The fast-track COVID-19 procedure for academic studies is outlined in detail in the following document: COVID-19 fast track procedure for academic studies. Please carefully follow these guidelines.
FREQUENTLY ASKED QUESTIONS (FAQ) ABOUT ACADEMIC CLINICAL STUDIES SINCE COVID-19 MEASURES WERE TAKEN
The chief physician of Ghent University Hospital also stated the following: “Consultations and treatments that cannot be suspended for 12 weeks, can be performed. However, new patients should no longer be included in interventional studies. New studies cannot be initiated, except if there is no physical contact with the participants (only by phone or e-mail). RX, CT and MRI scans of patients suspected with COVID-19 are performed at Emergency Radiology. Necessary CT and MRI scans for oncology studies may continue to be performed (e.g. to evaluate the effect of potentially toxic chemotherapy). Studies initiated in another hospital follow the guidelines from that hospital.”
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. Please carefully follow the guidelines described in this document.
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…)
Clinical Trial Unit Manager: Dr. Philippe Van Rompaey