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Establishing which source version a country package uses

A document can look current in a country package without having been produced from the correct source version.

Representative research photograph: Establishing which source version a country package uses
Photo: Bill Branson (Photographer) · License: Public domain · Cropped and resized.
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A document can look current in a country package without having been produced from the correct source version. Different filenames, email attachments and parallel working copies may circulate simultaneously. Sponsors should show which controlled source supports a local document and how later revisions will reach its owner.

Decision framework

Separate source-document ownership from local compilation responsibility. Connect each local output to its source version, translation or adaptation status and authorised acceptance. A computer's last-modified timestamp is not the scientific version of a document. Teams need a shared understanding of the applicable source location and access arrangements.

Worked example

For example, a local team uses the latest email attachment, but that file is an unaccepted draft. Other countries proceed with the previously approved version. A version map reveals the difference and prompts assessment of the local outputs produced from the draft. A newer date does not automatically make a file the appropriate source.

Implementation checks

  • Display source version and acceptance status in the local inventory as explicit fields rather than relying on filenames alone.
  • Define how source revisions reach country owners and how receipt of the relevant update will be confirmed.
  • Before submission, test whether a sample local document can be traced back to its controlled source version and supporting decision.

Acceptance and boundaries

Accept the arrangement when a new team member can explain why the document is considered applicable. Version management is more than strict folders; it preserves connections between content and decisions. Country-specific implementation dates and necessary approval routes still require appropriate specialist assessment alongside the source map.

Frequently asked questions

Is the newest-dated file necessarily the current version?
Not always. Verify its controlled version and acceptance status.
Can a local team change the source independently?
Authority and the change process should be explicit rather than leaving source ownership uncertain.

Sources

  1. EMA — CTIS sponsor handbook and support
  2. EMA — ICH E6 good clinical practice