Program Description

Clinical Research Professional Certification Preparation and GCP Review Course

Goal: The purpose of this workshop is to assist the participant in preparing for the CCRP certification examination.  This course will review the concepts identified in the CCRP Certification Examination Content Outline, as well as the Standards of Practice including the ICH Guidelines and FDA Regulations that govern clinical research practice.

Objective: The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records.

Learning Objectives: Upon completion of the workshop, the attendee should be able to:

  • Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
  • Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
  • Explain the drug/biologic development process
  • Describe the device development process
  • Outline concepts for Good Clinical Practice (GCP)
  • Explain the elements of informed consent
  • Describe the membership and reporting requirements of IRBs
  • Explain rules relating to financial disclosure
  • Discuss the basics of study design
  • Explain the rules and reporting requirements for adverse events and serious adverse events
  • Explain study closure procedures and record retention guidelines
  • Outline the reasons for monitoring, audits and site visits
  • Explain the Food and Drug Administration rules, regulations, and guidelines on research
  • Discuss the importance of investigational drug accountability
  • Demonstrate and describe how to read clinical reports and records
  • Discuss Quality Assurance including, Monitoring and Auditing
  • Explain issues that would constitute clinical fraud