Migrating to 5.0

In Calyx RIM 5.0, the entity XML for Clinical Trial Application (CTA) has been updated to support enhancements for CTAs submitted in the European Union. When a new CTA is created, it will use the updated Clinical Trial Application Entity XML type. Investigational New Drug (IND) applications for the U.S. have also been updated. When a new IND or INDCDN application is created, it will use the new Investigational New Drug Entity XML type. Additional steps are needed for post-migration for IND applications.

Users now have the ability to define and share the data elements that are common for a particular protocol. Comparators and placebos can be tracked on applications tracking one protocol (i.e., CTA Types) as well as on applications that track all the protocols for the life of a product (i.e., IND Types).