About
The Certified Clinical Research Associate (CCRA®) credential formally recognizes clinical research professionals with extensive experience in monitoring and overseeing clinical trials on behalf of sponsors. It highlights proficiency in ensuring trials are conducted according to ethical standards, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CCRA® credential is a trusted mark of excellence in clinical research, distinguishing professionals who meet industry standards for trial management and monitoring.
Certification Body
Association of Clinical Research Professionals (ACRP®)
Learning Objective
Participants will develop advanced skills in clinical trial monitoring, regulatory compliance, and stakeholder communication. The training equips candidates with the ability to:
- Monitor clinical trials to ensure compliance with study protocols, regulatory standards, and Good Clinical Practice (GCP) guidelines.
- Understand the design and phases of clinical trials, including preclinical and Phase 0–4.
- Apply advanced knowledge of randomized controlled trials, including blinding, allocation concealment, and outcome validity.
- Ensure accurate data collection and reporting at research sites through regular audits and site visits.
- Address ethical considerations, particularly when working with vulnerable populations (e.g., children, prisoners, pregnant women).
- Communicate effectively with all stakeholders involved in clinical trials, including sponsors, investigators, and regulatory bodies.
- Manage roles and responsibilities of Contract Research Organizations (CROs) and sponsors during clinical trials.
- Analyze and report on clinical trial data, ensuring integrity and validity in research outcomes.
Exam Information
- Duration: 3 hours
- Number of Questions: 125 multiple-choice questions
Recertification
- Validity: 2 years.
- Recertification Options:
- Earn 24 CE credits in clinical research, or
- Retake and pass the CCRA® exam.
- Submit Proof: Provide CE credits or exam results before the deadline.
- Lapsed Status: If not recertified on time, retake the exam to regain certification.
For More Information
Curriculum
- 1 Section
- 5 Lessons
- 40 Hours
- CONTENT :5
- 1.1Roles and relationships in clinical trials: sponsor, IRB, CRA, CRC, and site staff.
- 1.2ICH GCP E6 principles and guidelines.
- 1.3Ethical considerations in research, especially in vulnerable populations.
- 1.4Advanced clinical trial designs and phases.
- 1.5Regulatory compliance, reporting responsibilities, and communication strategies for blinded and un blinded staff.
Requirements
- Work Experience:
3,000 hours of verifiable experience in clinical trial monitoring within the last 10 years.
Must be paid work related to human subject research. - Excluded Experience:
Internships, unpaid work, or degree-related experience.
Experience older than 10 years. - Experience Waiver:
Up to 1,500 hours waived for: Active ACRP certification. Completion of an accredited clinical research education program aligned with ACRP standards.
Target audiences
- Clinical research professionals with trial monitoring experience.
- Graduates in science, healthcare, or related fields.
- Healthcare professionals and researchers aiming to advance in clinical trials.
- Individuals seeking formal training for CRA certification.