The goal of this three-day training is to provide a comprehensive overview of the project management role and responsibilities. This course will provide new or aspiring clinical research project managers with the skills as well as necessary tools and processes to successfully manage projects in clinical research settings. The course review the FDA regulations and GCP, emphasizes the differences between key roles in clinical research, and provides tools to aid in application of clinical project management concepts and principles.
Review FDA regulations and ICH GCP E6 Guideline for Good Clinical Practice (GCP)
Describe project management as it applies to clinical research and in the management of clinical trials
Develop a monitoring plan which focuses on mitigating risks at both the program and study levels
Utilize effective communication and leadership skills for successful study management
DAY ONE 8:30 am - 4:30 pm
Clinical Research Studies Refresher
Good Clinical Practice and U.S. FDA Regulations Refresher
Comparing Drug and Device Development Pathways
INDs vs IDEs: Comparing 21 CFR Parts 312 vs. 812
FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions
Day to Day Differences in Medical Device Studies vs Investigational Drug Studies
Adverse Event Reporting and Product Complaints: “Is It Reportable?”
Product Accountability: “Where does the Pharmacy fit?”
Special Considerations for Securing Compliance
Debate Club: Notes-to-File, Delegation Logs, Consent Notes
Thinking Critically about Requirements, Best Practices, and Pitfalls
Key Roles and Responsibilities in Clinical Research Overview
Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager and Statistician
Risk-Based Monitoring (RBM)
RBM Overview: FDA Guidance and ICH GCP E6
Developing Monitoring Plans: Planning and Implementation
Risk-Based Monitoring Throughout a Study: Best Practices & Methods
DAY TWO: 8:30 am - 4:30 pm
Clinical Research Project Management: Planning
Creating the Project Plans and Work Breakdown Structure
Assessing Risks and Developing Mitigation Strategies
Project Budget Considerations: Planning and Oversight
Assembling and Training the Sponsor Team
Clinical Research Clinical Project Management: Start-up
Vendor Selection and Management
Developing Study Documents and Site Files
Site Assessment and Selection
Site Start-up and Initiation
Research Off the Rails: Getting Your Clinical Study Back on Track
“What do I do when I realize there is a problem?”
DAY THREE: 8:30 – 4:30 pm
Ongoing Project Management: Documentation
Maintaining the Sponsor TMF
Documentation in Clinical Research for Sites: What is REALLY Needed
Ongoing Project Management: Tools, Strategies, and Effective Communication
Effective Metrics: Benefits for Tracking Clinical Study Details
Schedule and Time Management
How to Run Effective Meetings: 8 Steps to a Successful Meeting
Leading Teams: Managing Difficult Personalities and Having Challenging Conversations
Ongoing Project Management: Vendor Oversight and Expectations
What Does GREAT Monitoring Look Like?: “Take Your Team’s Monitoring from GOOD to GREAT!”
Excellent Monitoring Reports: What to Look For?
Follow-up and Follow Through: Ensuring Effective Site Management by Vendors
Working with Your Monitors to Ensure Timeliness, Quality, and Study/Site Compliance
Project Close-Out: Getting to the Finish Line
Project Management in Practice: 5 Things That Aren’t (Normally) Taught in PM Class
TYPE
KNOWLEDGE LEVELS:
WHAT’S INCLUDED
New clinical research Project Managers
Experienced Project Managers without formal project management training
Newly hired Clinical or Project Leads who will be managing at the sponsor, CRO, or investigational site
Clinical Research Associates, Data Managers or other research personnel interested in transitioning into a Clinical Project Management role
