Clinical Intelligence Update

MOH/FDA Delay Default Updates

Release 5.8 has been enhanced with updated MOH/FDA Delay Defaults effective for 2018.

ClearTrial continuously monitors the regulatory landscape to provide the latest industry observed Ethics Committee and Regulatory application processing delays. The observed changes are represented by the new MOH/FDA Delay Defaults in the application. The following supported countries and economically grouped regions have updated MOH/FDA Delay Defaults in 5.8:

Asia (CT-defined economic region)
France
Portugal
Russia
Spain
Thailand

The updates to these location-specific defaults only impact new plans using the 5.8 Cost Model or if new locations are added to existing plans, unless you are importing the location-specific overridden MOH delay value from another plan/template.

Updated Default Cycle Times

The default number of days in the Timelines section of the Plan Data tab have been updated to align with industry standard timelines. These include the following assumptions which vary by study phase and data collection method:

Days from LSO/LPO until Database Lock
Days from Database Lock until Statistical Report due
Days from Database Lock until Draft Report due
Days from Database Lock until Final Report due

Default Data Management and Data Entry Labor Update

The 5.8 Cost Model brings reorganized data entry and data management tasks to better separate and distinguish tasks that are not applicable when EDC is being used. These updates will be seen in plans using the 5.8 Cost Model.