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

The purchase of this course is optional. It is not required to sit for or pass the CCRP certification exam. Purchasing and completing this course will not guarantee a passing score on the CCRP certification examination.