The CRA Trainer: An Interactive Companion to The CRA’s Guide to Monitoring Clinical Research

The CRA’s Guide to Monitoring Clinical Research is the go-to resource of the trial monitor, training clinical trial professionals for more than 15 years.

But book learning doesn’t work for everyone, and CRA trainers need more options for a comprehensive, educational tool.

Introducing The CRA Trainer, a new online course and companion to The CRA’s Guide that offers practical exercises, mini-quizzes and real-world scenarios to help guide the trainee through the lessons presented in the book and apply them on their daily job:

• Familiarize yourself with the roles, responsibilities and important personality characteristics of an effective CRA
• Assess clinical trial regulatory history and current rules
• Critically evaluate the research process from the lab to the trial to trial closeout
• Get a sense of roles and responsibilities of IRBs and Data Safety Monitoring Boards
• Identify the principles and challenges of informed consent
• Understand study design and statistical analysis
• Find out more about adverse events and safety monitoring
• Evaluate quality management and prepare for audits
• Learn to identify fraud, mistakes and errors

The course consists of six individual modules that break the information in The CRA’s Guide into easily readable chunks:

• Module 1: CRA roles and responsibilities, regulatory history and compliance, principles of good clinical practice
• Module 2: The clinical research process, device and biologics trials, globalization, IRBs and data safety monitoring boards
• Module 3: Informed consent, preparing for a study, clinical investigators
• Module 4: Study initiation, study monitoring, adverse events and safety monitoring, recruitment, retention and compliance
• Module 5: Study closeout, quality management, audits, errors and misconduct, the future for CRAs
• Module 6: Final Exam — review and test on the previous five modules

Each module takes 20-30 minutes to complete. A certificate of completion is awarded to those who pass the post-course assessment, which may be submitted to the Association of Clinical Research Professionals (ACRP) for self-reported continuing education units toward maintenance of their professional certifications.*

Whether you are an individual who wants to move up to a career in trial monitoring, an experienced CRA who needs to stay on top of developments in the profession or a trainer preparing groups of trainees to take on the job of CRA, The CRA Trainer is an invaluable tool for gaining — and proving — mastery of the job.

Who Will Benefit

• Clinical trial sponsors
• Academic research centers
• Contract research organizations
• Clinical trial service organizations
• Clinical trial professionals who would like to transition to a career in trial monitoring
• Directors of research and clinical operations
• Trial monitor trainers
• Experienced CRAs looking to advance their careers

*Successful completion of this program has been approved for a total of 3.00 self-reported contact hours of research-specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.