Society of Clinical Research Associates ( SOCRA) Clinical Research Professional Certification Preparation and GCP Review Course is organized by Society of Clinical Research Associates (SOCRA), Inc. and will be held on Oct 03, 2022 at Wisconsin Union Hotel, De Pere, Wisconsin, United States of America.

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.

Objectives Topics:
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


Event Start Date
03 Oct, 2022
Event Start Date
Event End Date
03 Oct, 2022
Event End Date


PhysicianNursingResearchersClinical Researchers


Research and Clinical Research


Wisconsin Union Hotel
1308 W Dayton St, Madison,
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