eTMF-EMS repository

  • Published by Viedoc System 2021-11-24
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Introduction

The eTMF-EMS repository can be used for archiving the sponsor and/or investigator side of the study and/or exporting the documents that are included in the structure. It is compatible with the Exchange Mechanism Standard (EMS). Read more about the EMS here.

The eTMF-EMS repository respects the user roles and access to documents, sites, countries, and eTMF side.

Generating and downloading the EMS repository

To generate the repository:

1 Set the options (1) for the documents you want to include in the archive. You can choose to include documents that are filed to the investigator or sponsor side of the eTMF, and documents that are filed on trial/country/site levels according to your permissions to those.
2 Set the milestones-milestone groups (2) you would like to filter by.
3 Click Generate (3).
4

Click the generated document link to download the zipped folder (4).

The zipped folder structure and content

The zipped folder structure mirrors the eTMF structure used for the study as follows:

  • Level 1 – on this level there is:
    • The main zipped folder which name is in the format: StudyName_eTMFArchive_DatetimeStamp
      • StudyName - the study name
      • eTMFArchive - static text
      • DatetimeStamp - the UTC date and time of generating the eTMF-EMS repository in the format YYYYmmDDHHMMss
  • Level 2 – on this level there are:
    • A subfolder which name is the TransferID (datetime stamp of generating the eTMF-EMS repository) in the format YYYYmmDDHHMMss
    • An exchange.xml file for each chosen milestone. You can read about the content of the xml files and find an example here.
  • Level 3 – on this level there is:
    • A folder with ZoneID.ZoneName for each included zone from the structure.
  • Level 4 – on this level there is:
    • A folder with ZoneID.SectionID.SectionName for each included section from the structure.
  • Level 5 – on this level there is:
    • A folder with ZoneID.SectionID.ArtifactID.ArtifactName for each included artifact from the structure.
  • Level 6 – on this level there are:
    • Documents filed to this artifact on trial level.
    • Subfolders for included countries with country code as their names.
  • Level 7 – on this level there are:
    • Documents filed to the artifact and linked to this specific country.
    • Subfolders for sites in this country with site names as their names.
  • Level 8 – on this level there is:
    • Documents filed to the artifact and linked to this specific site.

The zipped folder includes all the versions of documents included in the structure. The name of the files will be as follows:
CurrentDocumentName-SystemVersion.extension, where:

  • CurrentDocumentName is the latest document name
  • SystemVersion is the integer value of the version set by the system for this file

If there are multiple documents of the same name filed to the same artifact and linked to the same levels, the system will add (n) as a suffix to the document name to ensure that all files are included in the zipped folder and no files are overwritten.