European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on April 04, 2022, by updating the below documents in Module 07- Management of registered users and role matrix:
- Roles and permissions matrix summary – Sponsors workspace – Module 07 (v2.28): Updated permissions in sections 2.2 and 2.3 by adding Compliance Req. 2016/679 in sub-section of forms. A footnote was also added stating that ‘section 2.3 is only applicable for transitional trials’
- Member states business processes and roles – Module 07 (v1.68): Updated with minor grammatical and word rephrasing changes
EMA also updated the Roles and permissions matrix summary – Authority workspace (v2.23) and Sponsors business processes and roles (v1.45) documents in Module 07.