Released January 27, 2014
The following changes apply to Study Teams:
When entering a National Clinical Trial (NCT) number using the Update NCT Number activity, users must now enter only numbers in the field provided. Alpha-numeric values are no longer accepted in this field.
The Calendar Review and Analysis Office (CRAO) now has the ability to exempt certain studies from needing an NCT number for billing purposes only. If a study is determined to be NCT exempt by CRAO, study teams will recieve an email notification and the Regulatory Affairs Office (RAO) will review the application to determine whether an NCT number is required for regulatory purposes.
An error displaying incomplete change log entries (recording that a change had been made, but no details about old or new values) for changes to subject enrollment numbers from all study locations (Protocol question 8.1 / Continuing Review question 2-2.1) has been fixed.
The following changes apply to CRAO:
CRAO now has the ability to exempt certain studies from needing an NCT number for billing purposes. Click the Update NCT Exempt Status activity in the applicable study workspace and enter the required information in the pop-up window that displays.
The following changes apply to Core Staff:
When reviewing a study with an auto-generated contingency due to it being sponsored by one of the branches of the Department of Defense (DoD), the Guidance for Investigators link has been updated with a new URL.