European Clinical Trial Regulation (EU-CTR) 536/2014 is expected to go into application in January 2022 with the go-live of the Clinical Trial Information System (CTIS). It will require all stakeholders to submit clinical trial information through the CTIS electronic platform.
With the regulation pending, the need to create regulatory documents with disclosure in mind has never been more important. Sponsors should design and use document templates to streamline the process. Templates help ensure that the content is disclosure ready, with selected elements of the protocol & clinical study report (CSR) written in plain language, which ensures consistency and ensure consistency across studies, disease states, regulatory agencies, and documents such as the informed consent form (ICF) and plain language summaries (PLS).