Setting up the eISF PORTAL

The eISF PORTAL is a view designed specifically for site users. 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.

There are certain steps the study team must take to set up the eISF PORTAL:

1. Create a study with an eTMF reference model. The eISF PORTAL relies on the TMF Reference model selected, so there must be one selected for that study. 
2. Add all the participating countries to STUDY PROFILE Section 2 and participating sites to SITES & CONTACTS. 
3. Define the site and country essential documents and enable the country folders in the STUDY PROFILE Section 3a. These document definitions are what will be included in the list of documents the site is required to upload.
4. Add the document records and files the site needs to download within the DOCUMENTS view. These are document records and files are what will be included in the list of document the site is required to download.
5. Enable the eISF PORTAL in STUDY PROFILE Section 3b and define the list of documents to be included in the eISF PORTAL. This includes adding document files for the sites to download, and document definitions for the site to upload. You can also define a startup/reg packet. Once all changes are complete, change the status of the portal from "Paused" to "Live." 
6. Invite site staff to access the eISF PORTAL within the SITES & CONTACTS view
7. The eISF Collaborator (or a Site Manager) activates account and logs in to the eISF PORTAL
8. The eISF Collaborator (or a Site Manager) can now download the study documents provided and upload their site specific documents. All documents that get uploaded are automatically sent to that site's "Inbox" within the DOCUMENTS view for the study team to review and add to their eTMF. 
9. Within the DOCUMENTS view, the site's "Inbox" folder now contains the documents from the "Documents for Upload" list that the site has attached files to. You can review those documents, add details, and use the "File to TMF" button in the Document Edit popup to move those to the appropriate folder in the TMF structure. 

Users Access Requirements

Admin, Manager, Associate, Document Manager

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.
eISF Collaborator	A User Role designed specifically for site staff who only need access to the eISF PORTAL to exchange documents with the study team

 

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