THE FUNDAMENTALS OF CLINICAL RESEARCH - CRA CERTIFICATE
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.
- Identify the GCP monitoring elements of informed consent and human
- Develop monitoring strategies to review source documents, identify
differences between source types, and assess data quality using the
- Verify adverse events, eligibility, and investigational product
- 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.
- Extensive education in ICH Good Clinical Practices and in the federal
regulations that pertain to drugs, biologics, medical devices, and
- 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.
- 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
- PART 1 (ONLINE): $1,700 required for online access, course text, and materials.