1. User Guide for Sponsors
  2. Create an archive
  3. PDF output options
  4. About Electronic Trial Master File (eTMF)

About Electronic Trial Master File (eTMF)

About eTMF

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

The primary purpose of this feature is to allow you to programmatically transfer archives from the Oracle sFTP server to your eTMF system.

Downloading files manually from the sFTP server, while it can be done, is not recommended as no data protections are applied to the content on the Oracle sFTP server, like in Oracle InForm CRF Submit.

Also, archives manually downloaded from the sFTP server are not tracked in the Download Log or the Site Confirmation report.

eTMF setting and archive retention

  • To enable this feature, see Specify trial settings
  • Once the feature is enabled, the setting, Allow PDF request to be stored in eTMF, is available for the following archive types:
  • When the setting Allow PDF request to be stored in eTMF is set to Yes, archives are delivered to the sFTP server and are available in the Oracle InForm CRF Submit 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:

The data included in a request is based on the rights group selected when the request was generated. 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: (Ex.) Requesting the creation of an sFTP named account.
    • Severity: Medium
    • Description: Grant <enter first name, last name, and email> Read Only access to the sFTP directory defined in this request.
    • Category: Change-Cloud Infrastructure > Infrastructure Services > SFTP > User > Add
    • 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: Reach out to your Oracle Services contact to get the sFTP 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.

Parent topic: PDF output options