Course Content
Introduction to Clinical Research
0/5
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
0/6
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
0/5
Study Design Types
Protocol Development
Endpoints and Outcome Measures
Study Population
Sample Size and Statistical Considerations
Site Management and Coordination
0/6
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
0/6
Case Report Forms (CRFs)
Source Documentation
Data Accuracy and Integrity
Data Management Systems
Adverse Event (AE) Reporting
Protocol Deviations
Monitoring and Auditing
0/5
Site Monitoring Visits
Audit Readiness
Quality Assurance
Investigational Product Accountability
Corrective and Preventive Actions (CAPA)
Clinical Trial Financial Management
0/4
Budgeting for Clinical Trials
Contract Negotiation
Billing Compliance
Resource Allocation
Ethics and Legal Aspects of Clinical Research
0/5
Ethical Principles in Research
Informed Consent Process
Conflict of Interest
Legal Responsibilities of the CRC
Confidentiality and Privacy
Preparing for the CCRC Certification Exam
0/4
Key Concepts Review
Practice Questions
Study Tips
Mock Exam
Post-Certification and Career Development
0/4
Career Pathways
Continuing Education
Networking
Staying Current
Certified Clinical Research Coordinator (CCRC): Full Certification Course Syllabus
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