Database closed for new patients from May 1st
Please note that since May 1st the international database has been closed for first presentations of COVID-19. Since we also collect data at the time point 3 months after the COVID-19 diagnosis, this implicates that the final date on which data will be collected is July 31st, 2021. We will close the database on August 15, 2021. After this date, you can still enter data in REDCap if you wish (for your own records), but we will no longer perform validations on data entered in the database.
Only new patients from the Netherlands can still be entered so that their data can be linked to the national vaccination study RECOVAC.
Because this initiative is meant to analyze and improve patient care, and is purely observational, the Institutional review Board (IRB) of the University Medical Center Groningen in The Netherlands waived the approval in the context of the Medical Research Involving Human Subjects Act and confirmed this in writing. It may be, however, that in your institution the situation is different. In case of doubt, please check your local IRB. When needed, we can be of help with obtaining IRB approval.
The following documents (in English) are available that can be adapted to meet your local requirements:
Template letter for IRB approval
Template Study Protocol
Research data management plan
Template Patient information form opt-in
Template Signature page opt-in
Template Patient information form opt-out
Template Signature page opt-out
Template Data Transfer Agreement