.jpg){kind=link}
- Published
- Updated
- Sources checked
A publication copy must protect personal data while preserving the document information needed to understand the research.
CTIS personal data redaction — Define the regulatory scope
EMA transparency rules and its CTIS handbook describe publication and document preparation. Review document type and applicable publication rules before deciding what to remove.
CTIS personal data redaction — Build the working record
Create a redaction log linking each removal to its reason and reviewer. Inspect document properties, comments, tracked changes, embedded files and searchable text; a visible black rectangle may leave underlying data recoverable.
CTIS personal data redaction — Check before release
- Test copied text after redaction.
- Remove hidden comments and identifying metadata.
- Compare clinical meaning with the controlled original.
CTIS personal data redaction — Record the decision and handover
Release the public copy through an independent privacy and scientific check. Keep the original and the approved public version linked without exposing participant identifiers in the review log.
Frequently asked questions
- Is renaming the file enough to anonymise it?
- No. Content, metadata and embedded material all require review.
- Should every staff name be removed automatically?
- Apply the current rules to the role and document; blanket removal may distort required information.