Course Description
Concepts, practicalities, and realities of project management. Practical guidance from trial set-up to delivering targets, the problems of performing clinical trials and how to deal with project teams, deadlines, budgets, and resources.
Athena Title
Project Mgmt Clinical Trials
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
[(PHAR 6010 or PHAR 6010E) and (PHAR 6200 or PHAR 6200E)] or permission of department
Grading System
A - F (Traditional)
Course Objectives
Upon successful completion of this course, student will be able to: - Demonstrate knowledge of regulations, policies, protocols and/or procedures needed to control, maintain, and audit records for regulatory compliance of clinical trials - Identify proven quality control tools to collect and measure performance data and implement process improvements - Outline efficient processes for data management and adverse event reporting to streamline compliance requirements - Identify and prioritize financial, technical, and legal considerations for project success - Compare and contrast operational/data problems common in clinical trails management - Discuss contracts and subject enrollment strategies to minimize costs and stay on budget - Interpret leadership principles needed for project management of clinical trials - Outline effective team meeting skills that models good communication practices throughout a clinical trial - Discuss strategies needed to prevent and manage fraud and study misconduct
Topical Outline
1. Fundamentals of project management in clinical trials 2. Consideration and responsibilities of using human test subjects 3. Predicting costs and developing time-phased budgets 4. Management and communication skills for project teams 5. Managing project deliverables and measuring performance 6. Preventing potential project management conflicts
Syllabus
Public CV