About Electronic Trial Master File (eTMF)

Use this feature to send Archival PDF (sponsor), Archival PDF (site), and Custom PDF archive requests to the Oracle sFTP server, where they can be programmatically retrieved for import into an eTMF system.

About eTMF

• The primary purpose of this feature is to allow you to programmatically transfer archives from the Oracle sFTP server to your eTMF system.
• In order to maintain data integrity for your study, it is suggested that study users are not granted access to the sFTP folder.
  • Content delivered to the sFTP server includes all data the user who created the archive request can see in a study. In some cases, viewing this data could result in unblinding if the wrong user were to download and view it.
  • Manual downloads from the sFTP server are not tracked in the Download Log or Site Confirmation report.

eTMF setting and archive retention

• The setting, Allow archives to be stored in Oracle sFTP, is available for the following archive types:
  • Archival PDF (for sponsor users)
  • Archival PDF (for site users)
  • Custom PDF
• When the setting Allow archives to be stored in Oracle sFTP is set to Yes, archives are delivered to the sFTP server and are available in the Oracle Clinical One Platform user interface. When set to No, archives are only available in the user interface.
• Deleting an archive from one location (sFTP or the user interface) does not delete it from the other.
• Archives are automatically deleted from the sFTP server after 60 days and from the user interface after 120 days.

Named sFTP account details

The username and password of this account are used to access the Oracle sFTP server to retrieve requests programmatically. The email address, first name, and last name of an individual need to be included in the request to create this account.

WARNING:

Archives include all of the data the user who created the request can see in a study. The person associated with the named sFTP account can access the sFTP server and manually download requests. This could result in unblinding if the request contains data that the sFTP user should not have access to.

Request a named sFTP account

Follow these steps to create a request for a named sFTP account.

1. Log into Oracle Life Sciences Support Cloud.
2. Click Create Request in the upper-right corner, then select Change Request.
3. Click the Maintain an application tile.
4. Click the Request user access tile, then complete the following fields.
   • Summary: Requesting the creation of an sFTP named account and sFTP folder access.

     Note:

     If you want to grant permission to an existing sFTP account, enter Please grant folder access to an existing sFTP user.
   • Severity: Medium
   • Description: Grant <enter first name, last name, and email> Read Only access to the sFTP directory defined in this request.

     Note:

     To grant access to an existing sFTP account, enter Grant <enter username> Read Only access to the sFTP directory defined in this request.
   • Category: Change-Cloud Infrastructure > Infrastructure Services > SFTP > User > Add

     Note:

     Select Change in place off Add to for an existing sFTP account.
   • Customer: Select your company's name
   • Product: CRF Submit
   • Business Service: CRF Submit-customer name
   • Environment: Prod/Live
   • Implementation Window: Make a selection
   • Action: Leave set to No value
   • sFTP: Leave the check box unchecked and enter /clients/<enter tenant name>.crfs/ as the path. Requests for any study using eTMF associated with the tenant entered are deposited at this path.
   • Date Required: Enter a date

Error handling

If errors are encountered while copying files to the sFTP server, the request is marked as Failed in the user interface, and the reason captured (in the FailureReport.txt file) is Request output could not be copied to the sFTP location.

Note:

An archive can still be downloaded in the user interface even if an error is encountered copying files to the sFTP server.