Issue:
When a study type is updated from “Interventional” to “Expanded Access” the Design tab should no longer be relevant. Currently in PharmaCM the existing/previous data is not wiped out from the design tab. The XML will contain that data in the Submission XML and PRS will receive it unless it is removed.
Workaround:
You can manually remove the data
• Edit the Study Properties Screen, change the Study Type from Expanded Access to Interventional. Save and Check in
• Navigate to the PRF/Design tab. Edit the form to check it out, you should see all the Design fields displayed. Update the values selected in the dropdowns to ‘Select’; delete all the text values entered. Save and check in the changes
• Edit the Study Properties Screen, change the Study Type from Interventional back to Expanded Access. Save and Check in
• Navigate to the PRF/Design tab. Edit the form to check it out, you should see a message “The Design tab does not apply when the Study Type is "Expanded Access". .
Proposed Resolution:
We have raised ADO-2070 to wipe out previous/existing data from design tab when study type is updated from “Interventional” to “Expanded Access" in a future PharmaCM CT release.
Affected Versions:
All versions