CliniGA CRO

CliniGA CRO Blog

Checking draft comments and artifacts in submission packages

Even a substantively correct submission can mislead if it contains draft comments, hidden annotations or incorrect attachments.

Representative research photograph: Checking draft comments and artifacts in submission packages
Photo: Fogarty International Center from Bethesda, MD · License: Public domain · Cropped and resized.
Published
Updated

Even a substantively correct submission can mislead if it contains draft comments, hidden annotations or incorrect attachments. Sponsors should not reduce final package review to counting documents. The objective is to send the accepted content in an appropriate presentation without losing context needed for the intended assessment.

Decision framework

Distinguish working copies from submission copies. Establish suitable checks for tracked changes, comments, document properties and visible attachments. Preserving necessary internal review history differs from cleaning the filing copy; retain decision records in a controlled location. Confidentiality assessment remains a related but separate activity requiring its own appropriate review.

Worked example

For example, a submission PDF still displays a reviewer's comment about an obsolete product name. The text has been corrected, but the annotation layer remains. The team examines the actual rendered output, recreates the appropriate file and compares it with accepted content. A comment-free source view does not prove that the submitted copy is clean.

Implementation checks

  • Inspect visible content and relevant technical layers in the actual files that will be sent through the submission route.
  • Check unexpected attachments, draft pages and unresolved comments against the package inventory and accepted document set.
  • After cleaning, sample the scientific content and necessary links to ensure the process has not altered their meaning or function.

Acceptance and boundaries

Accept the package when the filing copy represents accepted content accurately and clearly. This example does not describe every platform's technical rules. Verify formal presentation and confidentiality conditions separately; cleaning must not become a way to remove necessary trial records or conceal a material unresolved concern.

Frequently asked questions

Should all comment history be deleted?
Treat preparation of the submission copy separately from retention of necessary internal decision records.
Is opening the file enough?
No. Assess its content, attachments and actual appearance appropriately.

Sources

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