On the 6th of July we have added two new Cover Letters. The first one is a separate Cover Letter for the Annual Progress Reports (APR) and the Clinical Study Reports (CSR) and the second Cover Letter is for a declaration for studies that are not subject to the WMO. Because the APR and the CSR are now in a separate letter the Cover Letter for ‘Others’ has been updated.
Periodic SUSAR/SAE Line Listings / Development Safety Update Report (DSUR) / Early Termination / Study on Hold / Dear Investigator Letter / End of Trial (EoT) Notification / etc.
Request for declaration of research not subject to the WMO