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.
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.
Direct shipment IP to patients
Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline(link is external) to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies.
The exceptions that were linked to the guideline and that were allowed during the epidemiological emergency situation no longer apply. Direct delivery of medication to the patient (as described in section 4 of the Belgian guideline) is no longer allowed.
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.
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.