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A blinded role in the EDC does not protect a study if treatment information appears in exports, support tickets or shared folders. Review the complete information route before granting access.
Separate information routes
Draw separate paths for blinded and unblinded activities, including laboratory data, randomisation administration and safety review. Define permitted recipients and escalation contacts. Check whether filenames, kit identifiers or report filters can reveal allocation indirectly.
Test the blinded export
Run a sample export using the actual blinded account and inspect columns, metadata and linked reports. Test support access and emergency workflows with representative scenarios. Record who may see an unblinding event and how relevant study decisions are documented.
Blinding checks
- Approve role-specific datasets and report templates.
- Review shared folders and notification recipients for leakage.
- Remove temporary access after its justified purpose ends.
Assess suspected disclosure
Accept the boundary after a reviewer follows a complete blinded workflow without receiving restricted information. When a possible breach occurs, preserve evidence, limit further distribution and obtain an authorised assessment of study impact. Technical access restoration alone does not resolve that assessment. Check presentations and meeting attachments too: the creator’s access does not establish that every recipient may see the same information.
Frequently asked questions
- Does masking treatment labels guarantee blinding?
- No. Indirect identifiers, derived values and access to other systems can still reveal allocation.
- Should emergency access use shared passwords?
- Use an attributable, controlled process with appropriate authorisation and records.