Protocol Amendments
Amend the protocol. Keep the study moving.
A Controlled Path for Mid-Study Changes
Harbor keeps the current approved study design running while your team prepares the amendment. Draft the changes, compare them against the active design, test them with UAT, and release them only when the study team is ready.
Prepare the Amendment
Start from the current approved study design and revise eCRFs, visits, edit checks, and source documents in draft while sites continue using the approved version.
Compare and Run UAT
Review what changed against the active design, generate UAT materials, and keep test data separate before the amendment is released.
Apply Changes Prospectively
Once approved, new events follow the amended design. Existing data remains tied to the version, forms, and rules in effect when it was collected.
Move Exceptions Forward
When a partially completed visit or event needs the amended design, Harbor carries matching data forward, shows the original and proposed forms side by side, and preserves the prior-version context for review.
Keep every record tied to the rules that governed it
Harbor keeps collected data attached to the study version, forms, and rules in effect at the time of collection. When a partially completed visit or event needs to move to the amended design, Harbor carries forward matching data without erasing the original context.
Historical eCRFs are not revalidated against amendment rules that did not exist when sites entered the data.
When upgrading the same field to an amended design, Harbor carries forward compatible values and file uploads without relying on field label or position.
After the amendment is live, sites can compare the original and proposed forms side by side before moving a specific visit or event to the amended design.
Bring us your messiest amendment.
We'll walk through how Harbor keeps the approved study running while your team prepares the amendment, runs UAT, releases changes prospectively, and handles the visits or events that need to move forward.