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.
Restarting activities related to clinical research after COVID-19
Policy UZ Leuven
Here you will find the policy of UZ Leuven for the restart of activities related to clinical research.
- The restart of clinical research activities will take place in 2 steps (step 2 under reservation).
- Initially, access to the hospital for external partners will be limited as much as possible.
- Research activities shall not interfere with the clinical care capacity.
- It is important that study teams make good arrangements with each other and, if necessary, also with the healthcare professionals and support services regarding the use of facilities and other logistical resources.
Study- or sponsor-specific instructions should be followed, provided that these do not conflict with the directives issued by the Belgian authorities, or those issued by UZ Leuven.
Submit restart to EC Research
When submitting a substantial amendment to EC Research for restart your research project, or when notifying EC Research for restart the recruitment of your project, please provide us an answer to the following questions:
- Will it be possible to respect the federal and institutional rules, e.g. social distancing, protective measures,...? Yes □ No □ NA □
- Is additional protective material needed in order to execute the study? Please specify. Yes □ No □ NA □
- How many additional persons (researchers/observers) are envisaged in the interaction with the participants?
- In which room/building will the study take place?
- If the study takes place in another institution, has this institution approved the re-start in writing? Yes □ No □ NA □
- Is there a need for modifying the ICF, and if so, please provide a changed version with track changes. Yes □ No □ NA □
- Is there a need for modifying the protocol, and if so, please provide a changed version with track changes. Yes □ No □
In order to restart the trial after a temporary treatment halt, a substantial amendment must therefore be submitted. The trial can only restart upon approval by the EC and if no motivated objections have been raised by the FAMHP within legal deadline. If the temporary halt is only a halt in recruitment due to the COVID-19 crisis, it will be acceptable to restart the recruitment when again possible after a notification only to the FAMHP and to the EC.
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.