CRA Certification Exam Review Course Outline

Exam Review Objectives

• Examine the origin, purpose, development, and benefits of certification
• Identify exam preparation strategies and resources
• Determine areas of competency to assess strengths and weaknesses
• Diagnostically review critical sections of the exam and help you assess your level of readiness
• Analyze critical pre-study, study conduct, and post-study responsibilities

What is Certification?

• Purpose, origin, and development of certification
• Benefits of certification
• ACRP CRA job analysis
• Exam content
• Strategies and resources to prepare for the exam

Project Activities

• Preparing the protocol
• Submitting and amending the protocol
• Project level activities

Pre-study Activities

• Coordination
• Reports and forms
• Administrative duties
• Pre-study visit

Study Management

• Study initiation
• Study monitoring
• CRF management
• Administrative duties

Study Termination

• Study termination visit
• Final study report
• Administrative duties
• Archiving
• Auditing and inspections

Requirements for Admission to the CCRA Exam

Completion of the CRA certification exam review does not guarantee acceptance to the exam. To be eligible to sit for the CCRA exam, each candidate must fulfill at least one of the following three combinations of education and work experience as a CRA. A minimum of 40 hours per week qualifies as full-time employment and a minimum of 20 hours per week qualifies as part-time employment, completed prior to the exam date. (See the FDA Certification Guide or the ICH Regions Certification Guide for more details.)

Note: A résumé or C.V. must be included with the exam application.