Comparing protocol versions

What an amendment changes in the schedule and in the eCRF.

When a protocol is amended, compare the old and the new version: the portal shows what changed in the schedule of activities and what that means for the eCRF.

How to compare

1. Upload both versions on the “Protocol to study build” page. Each becomes a draft.
2. Open either draft and press “Compare with another version”, or use “Compare two versions” above your drafts. Choose the old and the new version.
3. Download the changes as Excel to attach them to the amendment impact assessment.

To see it at once, press “Compare the versions” next to the training protocol YE-ONC-201: version 2.0 is compared with version 3.0 (amendment 2).

What is compared

• Visits: added, removed, renamed (the same study day under a new name), changed day, window, kind, contact (phone, at home) or event (after the last dose, end of treatment).
• Procedures: added, removed, reworded (the same form and a similar name), added to or taken off visits, changed footnotes (for example new PK time points).
• eCRF forms: forms new to the study, forms no longer needed, forms to add to visits or take off them. This is the list of build changes.

The protocols are compared as read. The comparison uses each draft as the portal proposed it from the document, so your own edits to the drafts do not appear as protocol changes. Check the result against the protocol's summary of changes.