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POLICY UPDATE: Senior leaders from the world’s leading research..
Certified Clinical Research Coordinator (CCRC): Full Certification Course Syllabus
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Course Content
Introduction to Clinical Research
Overview of Clinical Research
Role of the Clinical Research Coordinator (CRC)
Ethical Considerations
Overview of Clinical Trials
Good Clinical Practice (GCP)
Regulatory Requirements and Compliance
Regulatory Bodies
International Conference on Harmonisation (ICH)
FDA Regulations and Oversight
Institutional Review Boards (IRB)
Investigational New Drug (IND) and Investigational Device Exemption (IDE)
Regulatory approval processes for drugs and devices Informed Consent Process
Study Design and Protocol Development
Study Design Types
Protocol Development
Endpoints and Outcome Measures
Study Population
Sample Size and Statistical Considerations
Site Management and Coordination
Site Initiation and Setup
Patient Recruitment and Retention
Screening and Enrolling Participants
Study Start-Up
Visit Scheduling and Documentation
Investigational Product Management
Data Management and Documentation
Case Report Forms (CRFs)
Source Documentation
Data Accuracy and Integrity
Data Management Systems
Adverse Event (AE) Reporting
Protocol Deviations
Monitoring and Auditing
Site Monitoring Visits
Audit Readiness
Quality Assurance
Investigational Product Accountability
Corrective and Preventive Actions (CAPA)
Clinical Trial Financial Management
Budgeting for Clinical Trials
Contract Negotiation
Billing Compliance
Resource Allocation
Ethics and Legal Aspects of Clinical Research
Ethical Principles in Research
Informed Consent Process
Conflict of Interest
Legal Responsibilities of the CRC
Confidentiality and Privacy
Preparing for the CCRC Certification Exam
Key Concepts Review
Practice Questions
Study Tips
Mock Exam
Post-Certification and Career Development
Career Pathways
Continuing Education
Networking
Staying Current
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