As part of the clinical study, sponsors need to retain the documents that permit evaluation of the conduct of a clinical trial and the quality of the data produced (CPMP/ICH/135/95). These documents service to demonstrate the compliance of the standards of GCP and regulatory requirements.
The CDISC SuiteTM maintains the Trial Master File to facilitate management of all the documents during the clinical trial. It serves as the central repository for document provisioning to all down-stream modules.
The CDISC SuiteTM's Study Writer Module streamlines the creation of file tags and the Study Tagging File (STF) for archives and eSubmissions. All hyperlinks and bookmarks fully comply with the ICH's Electronic Common Technical Document (eCTD) standards.
The final eCTD package is inspected by both automated and manual processes to ensure its ultimate quality and integrity.
Functional Components of Study Writer