About Advanced Study Versioning (ASV)
- When you use ASV, the updates apply to all subjects whose visits are tried to the study version you select in study design - whether the visit, form, or question is already complete, in progress, or not yet started.
- You can also apply changes through the standard study versioning process. However, unlike ASV, standard versioning only applies prospectively: you must update each site to the new version, and the changes will not retroactively affect visits already linked to previous versions.
| Advanced Study Versioning (ASV) | Standard protocol change |
|---|---|
| Can be applied retroactively to visits already linked to an earlier study version. | Only applies prospectively to visits created after sites are updated to the new study version. |
| No need to manually assign the new version to each site. | Requires manual update of the study version at each site for changes to take effect. |
| Impacts subjects whose visits are associated with the selected study version (and later versions, if those contain the updated questions). | Impacts only subjects enrolled after the new version is assigned to the site. |
| Changes apply even if a visit or form is in progress or already complete. | Changes don't impact forms or visits already started or completed. |
| Assumes lower effort - fewer manual steps, faster rollout of mid-study changes. | Higher effort - requires version assignment per site and coordination with site staff. |
How does the system know what to update when ASV is used?
When data collection begins for a visit, the application locks in the study version assigned to the site (as defined on the Sites & Labs tab in Study Settings). That version determines which visit and forms the user sees.
- Updates visits that are already associated with the study version you selected.
- Updates visits in later study versions, if those versions also include the forms or questions you changed.
The updates take effect when you move the new study version to Testing or Approved.
Note:
The study version linked to a visit does not change after data collection has started. If multiple ASV changes impact forms across different study versions, the system applies each change based on the original study version tied to that visit.Suppose a subject starts the Baseline visit while study version 1.0.0.2 is assigned to the site. That visit is then permanently linked to version 1.0.0.2.
Later the study designer makes an ASV changes to a question and selects version 1.0.0.2 from the Apply Changes to Study Version drop-down. When the new study version (1.0.0.3) is promoted to Approved, the application automatically updates the impacted questions for all subject visits that were created under version 1.0.0.2 (and for later versions, if those versions also contain the updated questions).
When you move a study version that includes an ASV change to Testing or Approved, the application runs a background process (also known as an asynchronous job) that re-calculates the status of any forms and visits impacted by the changed. You'll see the updates applied once the process finishes.