Task 8.3. Optimisation of procedures to enable the start-up of data collection (FPI) for large pan-European clinical research studies within days after emerging infections outbreaks. (UMCU)

CRISP undertakes the following steps to shorten the data collection start-up time to a maximum of a few days for the ‘first patient in’ after emerging infections outbreaks:

Standardised dedicated procedures and processes will be developed for the very rapid implementation of surveys and clinical studies on the EDC platform in case of emerging infectious disease outbreak. These procedures will be related to: user and site management, workflow and e-mail implementation, designing of eCRF’s including extensive validation, acceptance testing and deployment to production. Procedures will also be developed to shift all regular activities within the CRISP team to implementation activities of the ‘outbreak’ study on the EDC system.
Repositories of participating PREPARE research sites and users will be created during peace time. Sites and user accounts will be created on the EDC platform for immediate use during an outbreak study.
Libraries of eCRFs based on pre-approved study protocols will be created on the EDC system for immediate use during an outbreak.
An e-learning course will be developed to train study personnel in using the EDC system.

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Herman Goossens


Deputy Coordinator:

Menno de Jong




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