Your study sponsor/CRO may choose to activate a study version for you. If they do, you do not need to follow these instructions, because the updated study version will automatically be applied to your participants. If the sponsor/CRO needs you to approve a version, you will get a notification at the top of the page indicating that an updated study version needs to be approved. Only one user needs to approve it.
Activating a New Study Version
At the beginning of a study or after a mid-study update, you may need to activate the new version to apply the changes to your participants. This action should be completed once IRB or ethics committee approval is granted. Contact your sponsor for more information on IRB or ethics committee approval.
- In eCOA, view the Study Details tab.
- To review the study version document, which includes survey screenshots and notification content in all patient languages at your site, select the Download icon
. All eClinRO and ePRO documents are downloaded. - After you review the collection, select the I’ve Reviewed and Am Ready to Activate checkbox, and select Activate.
When you go to the study site, it’s now marked as Active.
Viewing Study Version Documents
- In eCOA, select the Study Details tab and select the Download icon next to the Version number. All eClinRO and ePRO documents are downloaded.
- View the location where your computer stores downloaded files to view the collection document.
Viewing Past Versions
To view past versions, access the Study Details page in eCOA, and select View All Versions.
