Work Breakdown Structure (WBS) Update

This update includes various updates to the ClearTrial-defined WBS. In summary, the following updates are included in the ClearTrial 5.7 Cost Model.

• Introduction of the Lead CRA resource.

• Updated Major Tasks, Tasks, and Resources.

• Updates to defaults for ClearTrial-defined assumptions and level of effort calculations.

• New units of measure and cost drivers.

• A new 5-task structure for all site visit algorithms including Pre-study Site Visit (PSSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Site Close-out Visit (COV).

The following ClearTrial-defined Major Tasks and Tasks have been added or renamed in the 5.7 cost model:

Table 3-1 Added or Renamed Major Tasks

5.6 Major Task Name	5.7 Major Task Name
Site Audited	Quality Assurance - Site Audit
Pre-study Site Visit (PSSV)	Pre-study Site Visit
Pre-study Site Visit (PSSV) by Phone	Pre-study Site Visit by Phone
One Hour of Phone-based Monitoring	Phone-based Monitoring Visit
Onsite Monitoring Visit - Prep, Travel, Reporting, and Follow-up	Onsite Monitoring Visit - Non-SDV Activity

Table 3-2 Updated Tasks, by Major Task

5.6 Task Name	5.7 Task Name
Pre-study Site Visit	Pre-study Site Visit
(None)	Pre-study site visit - Trip Report Review
Pre-study Site Visit by Phone	Pre-study Site Visit by Phone
(None)	Complete phone-based pre-study site visit Trip Report Review
Site Initiation Visit	Site Initiation Visit
(None)	Site initiation visit - Trip Report Review
Site Initiation Visit by Phone	Site Initiation Visit by Phone
(None)	Complete phone-based site initiation visit Trip Report Review
Onsite Monitoring Visit - Prep, Travel, Reporting, and Follow-up	Onsite Monitoring Visit - Non-SDV Activity
(None)	Onsite monitoring visit - Trip Report Review
(None)	Onsite monitoring visit - Perform other onsite activities
One Hour of Phone-based Monitoring	Phone-based Monitoring Visit
Perform phone-based monitoring visit	Complete phone-based interim monitoring visit
(None)	Complete phone-based interim monitoring visit - Trip Report Review
Separate Drug Accountability Visit	Separate Drug Accountability Visit
(None)	Prepare for separate drug accountability visit
(None)	Travel to site to perform separate drug accountability visit
(None)	Follow-up for separate drug accountability visit
Site Audited	Quality Assurance - Site Audit
Conduct pre-audit discussions with clinical, regulatory and sponsor Travel to and from study site for audits Obtain and review investigator file documents for audits Write the audit report Review final audit report Conduct post-audit discussions with clinical, regulatory and sponsor	Site Audit - Preparation Site Audit - Travel Site Audit - Onsite Time Site Audit - Reporting/Follow-up Site Audit - Report Review by Mgmt
Site Close-out Visit	Site Close-out Visit
Conduct final onsite visit - Preparation Prepare site close-out monitoring report Complete drug reconciliation/accountability/return Review all regulatory documents Close out EDC Collect the investigator study report Return and/or ensure destruction of study drug Ensure close-out report issued to sponsor	Conduct final onsite visit - Preparation Conduct final onsite visit - Travel Conduct final onsite visit - Onsite Time Conduct final onsite visit - Reporting/Follow-up Conduct final onsite visit - Trip Report Review
Site Close-out Visit by Phone	Site Close-out Visit by Phone
Conduct final site visit (via phone)	Conduct final site close-out visit (via phone)
(None)	Conduct final site close-out visit (via phone) Trip Report Review

WARNING:

Before upgrading or copying any plan from a prior cost model, please make sure you have not created any custom Tasks or Major Tasks with the same name as those included in the 5.7 Cost Model. If you have, please remove or rename these prior to upgrading or copying those plans.

Updates to Units of Measure and Cost Drivers

• The unit for the Phone-based Monitoring Visit major task has changed from Hours to Phone IMV.

• The following new units of measure or cost drivers are available to leverage when defining custom algorithms:

  • Month

  • Day

  • Phone PSSV

  • Phone SIV

  • Phone IMV

  • Phone COV

Updates to Resources

• Existing QA01 - Compliance / QA Manager has been updated to QA01 - Quality Assurance Manager

• Existing QA02 - Compliance / QA Auditor has been updated to QA02 - Quality Assurance Auditor

• New CR09 - Lead CRA resource is included by default on all new visit-specific trip report review Tasks.

New Paradigm for Site Visit Labor

The Major Tasks listed below have been updated to use a 5-task pattern for the various activities performed for each visit. This includes preparation, travel, reporting/follow-up, onsite time and trip report review activities included by default under each type of site visit Major Task.