Generating and Sending End-of-Study Media

At the end of a study, you can generate archivable packages of eCOA data and send them to sites. These packages are designed to meet regulatory requirements for data retention and can be retained as part of the Trial Master File (TMF), as well as Investigator Site File (ISF).

End-of-study media generation helps meet the following data collection goals:

  1. Regulatory Compliance: Ensures adherence to global regulations concerning the archiving of clinical trial data.
  2. Data Preservation: Provides a complete snapshot of the eCOA data, including audit trails and user access information, for long-term retention.
  3. Transparency and Auditability: Allows for thorough review and verification of the data if required.

Only users with the following combinations of Security Profiles and Study Roles can generate this media:

Security Profiles System Administrator (no study role needed), Clinical Administrator, Study Team User
Study Role Study Builder, Lead Data Manager

All internal users with access to the type of data in the media can view the generated media in Vault. If the study contains restricted data, the end-of-study media always contains restricted data. Only users with restricted data access will be able to view the generated media.

Media Contents

When you generate this package, each study site has the following files generated:

  • Participant Reports: Individual PDF reports for each participant at the site, containing their survey data, compliance data, criteria check outputs (if any), and clinical data audit trail.
  • Site Non-Clinical Data Audit Trail Report: An audit trail of non-clinical data activities that occurred at the specific site.
  • Site Staff Access Report: A report detailing the user access for staff at the specific site.

The following study-level files are also generated:

  • Study Audit Trail: An audit trail of activities in eCOA Studio that are related to the study.
  • Study and Site Staff Access Report: An eCOA Vault report detailing user access for all study and site staff.
  • eCOA Vault Audit Trail for the Study, Study Countries, and Study Sites: A comprehensive audit trail of activities in eCOA Vault that are related to the study.

Generating End-of-Study Media

You can only generate end-of-study media for locked studies. You cannot generate end-of-study media if the system is currently generating end-of-study media for the study or the study is being unlocked.

Complete the following steps to generate the media:

  1. In eCOA Vault, open the study record.
  2. Select Generate End-of-Study Media. The files will generate in the background, and you will receive a notification when they are ready.
  3. On the study or site page, view the End-of-Study Media section, and select files to open and download.

Sending End-of-Study Media

You can send end-of-study media to each site for review and acceptance. You cannot send end-of-study media if the system is currently generating it for the study or the study is being unlocked.

Complete the following steps to distribute the media:

  1. In eCOA Vault, open the study record.
  2. Select Send End-of-Study Media to Sites . The Send End-of-Study Media to Sites box opens.
  3. Select the Investigators and/or Coordinators you want to send the media to for each site, and select Confirm. Only active staff are shown.

The media is sent to the selected site staff. You can view the status of each site in the Site Closeout field. See the Site Closeout Status Tracking section for more information.

You can also run the Site Closeout Report to view additional information on who downloaded and accepted the end-of-study media at the site . See Running eCOA Vault Reports for more information.

Site Closeout Status Tracking

When a site is locked, the site’s Closeout Status record is updated in eCOA Vault. The status changes allow you to track the site’s closeout progress.

Status Description
Not Generated The site is locked, but End-of-Study Media has not been generated for the site yet. This is the initial status when a site is locked.
Not Sent The End-of-Study Media has been generated for the site but has not been sent to the site yet.
Sent You have sent the End-of-Study Media to the site.
Downloaded A site user has downloaded the media in Veeva eCOA. The Last Downloaded By and Last Downloaded Date fields are updated in the Site Closeout report.
Accepted A site user has successfully accepted the media in Veeva eCOA. The Accepted By and Accepted Date fields are updated in the Site Closeout report.
Unlocked The site was previously locked and is now unlocked. This status is set when the site is unlocked, and it clears the download and acceptance tracking fields. This status indicates you must regenerate the End-of-Study Media and the site has to reaccept it.