At the end of a study, you can generate archivable packages of eCOA data and save them to your device to send to sites. These packages are designed to meet regulatory requirements for data retention and can be retained as part of the Trial Master File (eTMF).
End-of-study media generation helps meet the following data collection goals:
- Regulatory Compliance: Ensures adherence to global regulations concerning the archiving of clinical trial data.
- Data Preservation: Provides a complete snapshot of the eCOA data, including audit trails and user access information, for long-term retention.
- 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, a .ZIP file is created for each study site that contains the following information:
- 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:
- In eCOA Vault, open the study record.
- Select Generate End-of-Study Media. The files will generate in the background, and you will receive a notification when they are ready.
- On the study or site page, view the End-of-Study Media section, and select files to open and download.