COVID and clinical research
For every contact, the possible risks associated with the spread of the virus should be balanced versus the potential therapeutic benefit of patients or study participants. In any case, the number of contacts should be kept to a minimum during visits (i.e. no presence of observators or others), and there should be no need to use additional protective clothes in the context of research/research activities.
All decisions to adjust clinical investigation conduct should be based on a risk assessment by the sponsor (ICH GCP section 5.0) in collaboration with the principal investigators. It is expected that the sponsor performs a risk assessment of each individual ongoing investigation and the investigator of each individual participant and implements measures which prioritise subject safety and data validity.
We follow the same guidelines for clinical research as those for clinical care at UZ Leuven.
In concrete terms, this means that non-essential visits are strongly discouraged, but are currently not yet formally prohibited.
Obviously, visitors must respect the generally applicable precautionary measures (frequent washing of hands, mandatory wearing of a mouth mask and keeping a distance).
Visits that cannot be organised in a safe way cannot take place.
It remains the responsibility of the sponsor (i.e. the Principal Investigator in case KUL/UZ Leuven is the sponsor) to evaluate whether the practical implementation of the study needs to be adjusted, due to the applicable COVID-19 measures.
Because any change can also have an impact on the financial processing of the study, proactive contact should also be made with the Financial Officer responsible for the study, at CTC, so that it can be examined how the billing/invoicing can be put in order at a later stage.
COVID-19 related studies approved by EC Research UZ/KU Leuven
An overview of the COVID-19 related studies approved by EC Research, can be found via this link:
Covid-19 and telemedicine visits
In these exceptional circumstances EC Research would allow the PI or his delegate to use telemedicine visits. If the sponsor considers it necessary to amend the ICF and protocol for this reason, this means a substantial amendment needs to be submitted to EC Research. Please interact with PI and study team in order to decide where this is needed.
We will do our best to treat these amendments more rapidly, if this is the only issue in the study which is modified. Please clearly indicate “COVID-19” in the header of the mail for submission, and clearly highlight the proposed changes.
Covid-19 and pharmacy changed procedures
We would like to inform you that suppliers are no longer allowed to go to the pharmacy directly. All deliveries have to be delivered at the pharmacy warehouse.
If the sponsor wants the temperature logger/box back, it can be picked up at a later time in the warehouse. Temperature loggers are not read and returned in the warehouse directly.
Monitoring visits and site initiation visitis (SIV)
Following the relaxation of the measures due to the COVID-19 epidemic, it will be possible again to perform on-site monitoring visits at the pharmacy of UZ Leuven from 6th of July 2020. Please find more information about which visits are possible and the specific practical guidelines in the document below.
Direct shipment IP to patients
In the context of a clinical trial, and for all sites in Belgium where the patient cannot join the hospital to obtain the investigational medicinal product (IMP), it is allowed that – under responsibility of the principal investigator and without intervention of the sponsor, the IMP is sent directly to the patient via courier. The sponsor cannot intervene in this shipment as one needs to assure integrity and patient confidentiality.
This way, the IMP supply can continue respecting national and international rules. Obviously, the correct shipment conditions need to be respected. This process needs to be documented and fully traceable.
Please respect the national and European guidelines, as well as our internal hospital policy.
(Inter)national guidelines for clinical trials during COVID-19
- National guidance (including Frequently Asked Questions with answers)
- FDA guidance
- EMA guidance
- EDPB (European Data Protection Board) Letter concerning the European Commission's draft Guidance on apps supporting the fight against the COVID-19 pandemic
Submitting documents via CD-Roms is not recommended. EC cannot guarantee that these documents will be evaluated in time. Please provide the documents electronically.
If no wet ink signature is possible for EC submission, this can be replaced by email confirmation.
New trials regarding COVID-19 will be treated with priority by CTC and EC. The FAMHP commits to validate and review in four working days, as will do the evaluating EC.
Monitoring visits UZ Leuven
As long as non-covid clinical care is not restricted to the absolutely necessary clinics, the planned monitoring visits can proceed, but only on condition that the monitors/external visitors adhere to the present UZ Leuven COVID-guidelines.
This implies that monitoring visits are not allowed if the monitor returns from an orange or red risk area for which strict guidelines apply.
In this holiday season, this aspect requests specific attention. We request that the study team requires this information from the monitor/CRO/sponsor before the visit to UZ Leuven. A monitor/external person who has been in an orange or red zone in the previous 2 weeks should not be allowed to enter UZ Leuven.
More information on risk zones can be found on the website of Foreign Affairs.