Project Management in Clinical Trials
( 25 Modules )

Module #1
Introduction to Clinical Trials
Overview of clinical trials, their importance, and the role of project management

Module #2
Project Management Fundamentals
Basic principles of project management, including scope, schedule, and resources

Module #3
Clinical Trial Project Management Overview
Role of project management in clinical trials, including goals, objectives, and deliverables

Module #4
Clinical Trial Regulations and Guidelines
Overview of relevant regulations, such as ICH-GCP, FDA, and EU directives

Module #5
Project Management Methodologies in Clinical Trials
Overview of popular project management methodologies, such as Agile, Waterfall, and Hybrid

Module #6
Project Initiation:Understanding the Study Protocol
Review of study protocol, including objectives, endpoints, and timelines

Module #7
Project Scope and Stakeholder Management
Defining project scope, identifying stakeholders, and developing a stakeholder management plan

Module #8
Developing a Project Schedule
Creating a project schedule, including timelines, milestones, and critical path activities

Module #9
Resource Allocation and Budgeting
Identifying and allocating resources, including personnel, vendors, and budgeting

Module #10
Risk Management in Clinical Trials
Identifying, assessing, and developing mitigation strategies for clinical trial risks

Module #11
Study Start-up and Site Initiation
Preparing sites for study initiation, including training, and document management

Module #12
Patient Recruitment and Retention
Strategies for patient recruitment and retention, including patient engagement and retention plans

Module #13
Data Management and Quality Control
Overview of data management, including data collection, cleaning, and quality control processes

Module #14
Monitoring and Quality Assurance
Conducting on-site monitoring, quality assurance, and audit preparation

Module #15
Issue Management and Problem-Solving
Identifying, escalating, and resolving issues, including problem-solving strategies and root cause analysis

Module #16
Project Monitoring and Control
Tracking project progress, identifying variances, and taking corrective action

Module #17
Change Management in Clinical Trials
Managing changes to the study protocol, including amendments and revisions

Module #18
Study Close-out and Database Lock
Preparing for study close-out, including database lock, and finalizing study reports

Module #19
Project Closure and Lessons Learned
Conducting project closure activities, including documenting lessons learned and best practices

Module #20
Project Evaluation and Metrics
Evaluating project success, including metrics and key performance indicators (KPIs)

Module #21
Innovative Technologies in Clinical Trials
Overview of innovative technologies, including wearables, artificial intelligence, and blockchain

Module #22
Global Clinical Trials and Cultural Differences
Conducting global clinical trials, including cultural differences and regional nuances

Module #23
Project Management in Rare Diseases and Orphan Trials
Unique challenges and considerations for managing rare disease and orphan trials

Module #24
Sponsor and CRO Partnerships
Best practices for sponsor and CRO partnerships, including communication and collaboration strategies

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Project Management in Clinical Trials career

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Project Management in Clinical Trials ( 25 Modules )

Project Management in Clinical Trials
( 25 Modules )