Project Management

The CSO Project Manager (PM) is the primary point of contact and is responsible for communicating the scope of services, goals, progress against deliverables, budgetary information, and identification and resolution of issues across all study activities and clinics. The CSO PM will maintain regular telephone, e-mail and facsimile contact with Sponsor and / or third parties. Throughout the study, the CSO PM and Clinics will work closely together to monitor and to direct study activities to ensure expected study progress.

• Modified (Light) Booking System Administration

• The CSO PM and Clinic Manager(s) will collaborate with in-house technical staff to ensure proper set-up and configuration.

• Collection and / or Submission to Ethics Review Committee and / or Regulatory Authorities

The CSO PM will monitor the development and collection of all regulatory documentation across all participating CCBR locations. Data Quality On an ongoing basis, the CSO PM and Clinics will direct regular in-house quality control reviews and monitoring of key documents and processes including:

• Electronic Case Report Form (eCRF) quality control review against source data 
• Query handling - Drug accountability 
• Serious / Adverse Event Reporting (S/AE Reporting) 
• Training Throughout the course of the study, the CSO PM and Clinics will ensure that all applicable training is provided to CCBR study personnel, which includes re-training (if applicable). 
• Screening Activities / Subject Recruitment Targets On an ongoing weekly basis, CCBR will review targeted and actual enrollment by site through the completed enrolment logs. 

CCBR will review these logs and will be able to proactively detect a potential lag in study enrollment. If at any time the expected enrollment trajectory is not met, CCBR will investigate the root cause(s) and develop the appropriate enrollment correction strategies

Subject Retention Activities The CSO PM and Clinics will organize the retention activities and monitor the discontinuation rate of study subjects. This includes maintaining the highest quality in subject care and overall study subject experience at each of the participating clinics.

Study Project Plan

The CSO PM will create a sponsor-reviewed project plan, complete with all related milestones and dependencies. The project plan will be regularly updated to monitor progress against deliverables, which includes items such as the following:

• Site regulatory and initiation milestones 
• Screening commencement and randomization milestones 
• Data management milestones (if applicable) 

The CSO PM is responsible for tracking and communicating the status of project services to ensure that timelines for deliverables are executed on time. If a critical deliverable as defined in the project plan will be completed beyond expectations, it is the responsibility of the CSO PM to escalate and provide advanced warning and to present viable options.

Budget and Financial Monitoring

The project budget is based on the assumptions, tasks and delivery schedules detailed in this Statement of Work. The CSO PM will monitor the overall study scope and budget integrity. This includes the following:

• Ensuring the accuracy of all invoices 
• Enabling ready access to additional cost information (if required) 
• Addressing financial or contractual related questions in a timely manner 
• Providing rapid and accurate assessment of requested service scope changes If the scope of the project changes from what is outlined in the current SOW or additional services are requested, a revised SOW and term sheet will be submitted by CCBR for written approval.