TMF Archive

  • Published by Viedoc System 2023-10-09
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Complete audit trail report

Introduction

The complete audit trail report is in Excel format. It includes a complete list of actions done on:

  • the structure, templates, and settings by the eTMF Managers
  • the documents included in the TMF by the users
  • generating and downloading the complete audit trail report and the TMF-EMS repository

The report respects the user roles and access to documents, sites, and countries.

Generating and downloading the report

To generate the complete audit trail report:

1 Set the options (a) for the documents’ audit trails to be included. You can choose to include documents that are filed on trial/country/site levels according to your permissions to those.
2

Set the milestones/milestone groups (b) you would like to filter by.
3 Click Generate.
4 Click on the generated document link to download the report (c).

Included sheets

Each sheet in the complete audit trail report corresponds to the actions done by users on a certain view or section, as shown in the following table:

Trial Master File
Templates Management
Structure Management
Archive Management
Settings Management
Status Management

The report is self-explanatory but in the following sections you can find detailed information about each sheet in the file:

Report Info

This sheet includes general information about the report and the study. The First document added date/time and Last document added date/time show when the first and last documents were uploaded to the TMF regardless the audit trail of these documents is included or not in the report.

Trial Master File

This sheet includes information about all the actions done by users on documents in the Trial Master File view. Note that the actions that are included in this sheet are done on:

  • Published documents only.
  • Documents that are linked to a level (Trial/Country/Site) that the user chose to include and are filed to an artifact that is linked to a milestone that the user has filtered by.
  • Documents that the user has at least READ access to.

Templates Management

This sheet includes actions done by eTMF Managers on the templates. If the user doesn’t have access to TMF Admin view, this sheet is empty.

Structure Management

This sheet includes actions done by eTMF Managers on the instantiated structure. If the user doesn’t have access to TMF Admin, this sheet is empty.

Archive Management

This sheet includes this user actions done on the TMF Archive page.

Settings Management

This sheet includes the actions done by eTMF Managers on the Settings tab in TMF Admin. If the user doesn’t have access to TMF Admin, this sheet is empty.

Status management

This sheet includes the actions done by eTMF Managers on the Status tab in TMF Admin. If the user doesn't have access to to TMF Admin, this tab is empty.

eTMF-EMS repository

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 with a name 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 that has the name 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.