Step 5: Run the Amendment in Production
Once you’ve published your new version to your production environment, you can run either a retrospective or, if enabled, prospective amendment to migrate Sites and existing Casebooks to the new version.
Choose an Amendment Type
Depending on your design change, you can choose to run a retrospective amendment or, if enabled, a prospective amendment. Retrospective amendments apply changes to all data, including submitted Forms. Prospective amendments apply changes “this point forward”, only changing existing Casebooks after a certain Event.
|Retrospective Amendments||Prospective Amendments|
|With retrospective casebook amendments, Vault updates all existing casebook data to reference the new version, modifying any previously collected data to comply with the new version. For example, if a new version removed the Secondary Baseline Visit form from the study, a retrospective casebook amendment would remove the Secondary Baseline Visit form from any existing Casebooks, even if the site already collected data for that form.||A prospective casebook amendment is a study design revision that begins “this point forward”. Data managers can use prospective casebook amendments to apply a change to all existing Casebooks, starting at the chosen Start Event, without removing or updating any previously collected data.|
Update the Site’s Active Version
After running the amendment, update each site’s Active Version to reference the new version. Vault uses the Active Version for each site when creating new Casebooks.
To assign a casebook version to a Site:
- Navigate to Tools > EDC Tools > Sites.
- Click to open a Site.
- In the Active Version drop-down, select your new version.
- Click Save.
Vault now references your new version when creating new Casebooks.
Run the Amendment
Once a clinical programmer has published a new version of your study, you can deploy it to sites using a casebook amendment. Note that vault does not apply amendments to frozen and locked Casebooks or data.
- Detailed instructions for running a retrospective amendment
- Detailed instructions for running a prospective amendment
To run an amendment:
- Navigate to your Study in EDC Tools.
- Click Casebook Versions.
- Click Active Versions by Site.
- Select the Sites you want to move to the new version. You can choose one, some, or all of your Sites.
- Click the button or select from the Actions menu, New Retrospective Amendment or New Prospective Amendment.
- Select the Target Version. This is the new version that you are moving sites onto.
- Fill the required fields.
- Set the scope of your amendment:
- Select Update all subjects to update all subjects at the chosen sites.
- Select Update specific subjects to select individual subjects to update. If you choose this option, Vault displays a list of subjects. Select each Subject that you want to receive the amendment.
- Click Run Now. Vault begins a job to apply your amendment to your sites. As part of this process, Vault also re-runs all of your study’s Rules. Vault sends you an email notification when the job is complete. You can view the job’s status and log from EDC Tools > Jobs.
Resume Data Collection
Your existing Casebooks and your Sites are now on the new design version. You can resume data collection. Repeat Stage 4: Amendments each time you need to make a mid-stream change to your Study.