The eISF PORTAL is a view designed specifically for CRO and Sponsor clients to allow limited access to site users, and is available to Premium and Premium Plus clients. It is an electronic document exchange where the site staff can download study documents provided by the study team, and upload site documents for the study team to retrieve. It is NOT an electronic ISF or reg binder where site staff manage their site files. This is a secure document exchange between the study team and the site team, to ensure both parties have access to the documents needed for their respective internal files.
View of the eISF PORTAL
The eISF PORTAL is divided into two sections. Within both sections site users can search for specific documents, sort columns, and export the list as an external document.
Documents for Download
The Documents for Download is the list of documents the study team bas provided the site to be downloaded and added to their site files. Site users can use the "Download" link to download the document file to their local drive. Study team users can track what documents have been downloaded and by whom using the columns: "Date Downloaded" and "Downloaded By."
Documents for Upload
The Documents for Upload is the list of documents the study team has requested from the site for the study files (DOCUMENTS / eTMF). Sites will use the "Upload" link to the upload their site document file to the eISF PORTAL. Those documents will automatically appear in the DOCUMENTS / eTMF view under that site's "Inbox" folder. NOTE: Study teams can opt to have the sites use the "Email In" feature to email documents to the "Inbox" rather than upload them here.
The study team is responsible for setting up the study and the eISF PORTAL and defining the documents the sites will be required to either download or upload.
View of the STUDY PROFILE - 3b. eISF Portal Definitions
| Users Access Requirements | Admin, Manager, Associate, Site Staff - ST Manager, Document Manager, Site Staff - ST Viewer, Document Viewer, eISF Collaborator |
| Portfolio View Access Requirements | All Data, Studies + General Records, Studies Only, Sites Only |
| Subscription Requirements | Trial, Premium, Premium Plus, Enterprise |
| Glossary | |
| eISF Portal | An electronic document exchange where the site staff can download study documents provided by the study team, and upload site documents for the study team to retrieve. It is NOT an electronic ISF or reg binder where site staff manage their site files. |
| Document Definition | A record that outlines the metadata and requirements for a document record, that is applied to multiple document records. Managed within STUDY PROFILE Section 3a - eTMF Definitions. |
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