Increased Transparency into Monitoring Efforts

What's changed? The existing effort calculated for the "Monitored, Clean CRF Page" Major Task has been broken out into two distinct Major Tasks and Tasks to account for SDV and non-SDV related activities.

Existing 5.6 Major Task, "Onsite Monitoring Visit - Prep, Travel, Reporting and Follow-up" has been updated to "Onsite Monitoring Visit - Non-SDV Activity" and includes two additional Tasks for other onsite time and trip report review activities. Two new Tasks include the following:

• Onsite monitoring visit - Perform other onsite monitoring activities

• Onsite monitoring visit - Trip Report Review

The new Task for other time onsite is driven by a new "Other hours onsite per visit" assumption located on the Monitoring tab of your plans. This field allows you to specify the number of hours expected during each visit to perform activities not directly related to source document verification.

Separate Drug Accountability Visit Updates

To more accurately account for the various activities under the existing Separate Drug Accountability Major Task, the following Tasks have been added:

• Prepare for separate drug accountability visit

• Travel to site to perform separate drug accountability visit

• Follow-up for separate drug accountability visit

Default hours for the selected resource performing work on the existing ClearTrial-defined Task, Perform Separate Drug Accountability Visit has also been updated.

Monitoring Visit Time Calculation Update

The monitoring time per visit calculation has been updated to use the same Minutes per CRF Page value for the baseline visit and all interim visits.