While the Document Library contains ALL documents, the Study eBinder organizes documents by study, offering helpful views for internal and external users focusing specifically on study document progress. The Study eBinder is the equivalent of pulling your eRegulatory binder or ISF off the shelf. Each folder represents a set of documents, and upon expanding the folder, you can find each document type available for upload.

The Study eBinder provides tools to upload, finalize, and initiate workflows on documents.

Permissions

• Staff users have the “working view,” which includes document versions in the Draft state. This view helps to identify documents requiring attention.
• External users are limited to the “inspection view,” displaying only the approved and effective documents for the selected study.
• Site Viewer users can view documents on the Approval Needed tab, but do not have access to approve.