CRA Certificate Program

THE FUNDAMENTALS OF CLINICAL RESEARCH - CRA CERTIFICATE PROGRAM

The Fundamentals of Clinical Research (FOCR) is designed for individuals who are new to the clinical research industry or who are transitioning to monitoring from a different clinical research role.

The objectives of the course are to:

• Identify the GCP monitoring elements of informed consent and human subject protections.
• Develop monitoring strategies to review source documents, identify differences between source types, and assess data quality using the ALCOA-C test.
• Verify adverse events, eligibility, and investigational product accountability.
• Discuss corrective actions to resolve common issues regarding consent, source documentation, adverse events, product accountability and regulatory documents.
• Use a monitoring system to perform quality monitoring and generate a work product that allows for oversight.

FOCR is one of the only training courses that includes ALL of the following:

• Extensive education in ICH Good Clinical Practices and in the federal regulations that pertain to drugs, biologics, medical devices, and combination products.
• The MRM Step Method™ for standardized and effective monitoring
• One full week of hands-on monitoring using real-world case studies and medical records with mock/remote EMR access.
• Investigator Study File, Informed Consent Drills.
• Comprehensive Monitoring Competency, Securing Compliance & Writing Monitoring Reports.
• Monitoring Exercises with cases involving complex errors that demand high levels of critical thinking.
• Two-part exam: general FDA and GCP knowledge evaluation, and a hands-on Monitoring Competency Exam designed to test the student’s ability to identify and mitigate real-world monitoring issues.

The one-week virtual classroom session is dedicated to hands-on monitoring of three complete mock cases, including patient medical records, case report forms, regulatory binders and CAPA plans.

The course combines self-paced instruction and virtual training:

• 6 Self-paced online e-learning modules
• 6 day live virtual training session and hands on monitoring instruction.
• A monitoring and GCP exam administered on the 6th day to obtain certification.

Course Fee: $1,700

• PART 1 (ONLINE): $1,700 required for online access, course text, and materials.