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:
Monitoring & audit visits to be postponed
All monitoring, auditing and inspection visits to clinical areas within the hospital, including the pharmacy, remain suspended until further notice and at least until 18 May. Patient care remains a priority at UZ Leuven and external individuals will not be permitted to access the hospital earlier than our patients or their families.
Exceptions can be made for urgent audit or inspection visits, following approval from the UZ Leuven Chief Medical Officer. In such cases the visit may only be conducted at administrative trial units; i.e. locations that are non-accessible to patients.
If the PI approves, trial progress visits by the CRAs may be replaced by remote contacts (via telephone or email). However, under no circumstances can source data verification be performed through remote monitoring, nor can source documents be shared or reviewed outside the premises of UZ Leuven.
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.
The following could e.g. be inserted as information to the patient:
EC Onderzoek geeft tijdens deze periode van verhoogde alertheid omwille van COVID-19 de toestemming om de bezoeken aan het ziekenhuis in het kader van een klinische studie te vervangen door een telefonisch contact wanneer/waar dit mogelijk is.
De studiearts of zijn afgevaardigde zal hiertoe met betrokken patiënt contact opnemen.
Covid-19 and pharmacy changed procedures
Monitoring visits and site initiation visitis (SIV)
The following documents can be reviewed during the next monitoring visit (after these measures are canceled):
- Accountability documents
- Training Log/Delegation Log
- CV/GCP certificates
- Temperature logs: in case of an excursion, sponsor and CRA will be immediately informed by us
- Delivery documents: the current stock is monitored on a weekly basis and expiry dates are checked monthly.
Already booked site initiation visits (SIV) can proceed at the best possible manner (by skype, telephone, conference call, etc.). The pharmacist/staff member with whom you have made an appointment will contact you personally to discuss how to organize the SIV.
Important advice: The SIV can only proceed if the necessary documents have been provided to the pharmacy by e-mail (in accordance with our current working method): the latest version of the Pharmacy Manual, IB, Protocol and if the questionnaire (send to you by e-mail) has been answered. You may send the Pharmacy Binder in advance to the following address: Pharmacy UZ Leuven – Clinical Trials, Herestraat 49, 3000 Leuven.
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.
Direct shipment IP to patients
The Belgian competent authority has issued the following statement:
“In these exceptional conditions and until further notice we can foresee the following: In the context of a clinical trial, and for all sites in BE 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. The sponsor cannot intervene in this shipment as one needs to assure integrity and patient confidentiality. Obviously, the correct shipment conditions need to be respected. This process needs to be documented and fully traceable.”
EC Research UZ Leuven concurs with this statement.
Please follow the internal guidelines of UZ Leuven if you consider this: Rechtstreeks afleveren van studiemedicatie aan patiënten onder uitzonderlijke omstandigheden (COVID-19).
In any case, please make sure that study participants have enough study medication to avoid any treatment interruptions.
(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.
The use of non-steroidal anti-inflammatories for COVID-19
There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.
You can find the detailed advice on the use of non-steroidal anti-inflammatories for COVID-19 in the document below.