European Medicines Agency published the sixth Clinical Trials Information System (CTIS) newsflash over the What’s New Section on March 14, 2022:
This newsletter reports the key metrics for the period February 28, 2022, to March 06, 2022, including the total number of logins to CTIS, number of draft applications in CTIS, and number of submitted applications in CTIS. The spotlight of this newsletter updates that over ten clinical trials have been submitted for assessment to CTIS from which majority of studies are submitted by academic sponsors while a significant number of studies are submitted by pharmaceutical companies.
It explains in brief about the different user roles provided by CTIS to manage access to data and different parts of clinical trial. Roles like ‘viewer’, ‘preparer’, ‘submitter’ and grant roles are discussed in this section.
This newsletter provides the link for the templates provided by European commission for Part II clinical trial application documents, including investigator curriculum vitae (CV), site suitability form and informed consent document. These templates can be used by sponsors to draft their documents that are Clinical Trials Regulation-compliant. Further, it advises to refer Module 07 – Management of registered users and role matrix and CTIS sponsor user personas and sponsor organisation modelling documents for guidance on user roles.