COVID-19 impact on clinical trials, please find hereby communication from the agency: 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. 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.
What about when IMP needs to be prepared by the sites (emulsions to be prepared by the pharmacists for example), or administered under surveillance?
Ambtelijk secretaris METC NedMec (MREC), Psycholoog | clinical research | clinical trials | regulatory | EU CTR, MDR, IVDR | research ethics | privacy | human subjects research | research ethics review
4yBeCRO, the Belgian Association of CROs When will this information be available via the FAGG website?