February 2024 SOCRA Source Journal - Journal - Page 87
SOCRA Virtual Clinical Research Professional
Certification Preparation and GCP Review Course
MAY 4 AND MAY 5, 2023 I VIRTUAL
JUNE 20 AND JUNE 21, 2023 (+ MORE!) I VIRTUAL
Registration Fees: Member: $295, Non-Member* $370 *includes one year membership
Goal: The Society of Clinical Research Associates (SOCRA) recognizes Certified Clinical Resear`ch
Professionals (CCRPs) as clinical researchers who meet an internationally accepted standard of
knowledge, education and experience. The purpose of this workshop is to assist the participant in
preparing for the SOCRA examination for the Certified Clinical Research Professional examination
and to review regulations, policies, and procedures appropriate to the clinical research environment.
Objective: This interactive virtual workshop will be facilitated by clinical research professionals with a combined industry
experience of more than 20 years. The goal will be accomplished through lecture, discussion and practical application.
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 - The attendee should be able to:
• Discuss the basic requirements necessary to meet the
• Explain the rules and reporting requirements for adverse events
demands of a CRP in clinical practice
and serious adverse events
• Discuss the basic components of compliance • Explain study closure procedures and record retention
Law, regulation, guidance, policy and procedure
guidelines
• Explain the drug/biologic development process
• Outline the reasons for monitoring, audits and site visits
• Describe the device development process
• Explain the Food and Drug Administration rules, regulations,
• Outline concepts for Good Clinical Practices (GCP)
and guidelines on research
• Explain the elements of informed consent
• Discuss the importance of investigational drug accountability
• Describe the membership and reporting requirements of IRBs • Demonstrate and describe how to read clinical reports
• Explain rules relating to financial disclosure
and records
• Discuss the basic rules of study design
• Discuss Quality Assurance including monitoring and auditing
• Explain issues that would constitute clinical fraud
Course Overview
Discussion and Explanation of
Ethical Issues in Clinical Research
• Nuremberg Code
• Declaration of Helsinki
• Code of Federal Regulations (CFR)
• Belmont Report
• International Conference on
• Harmonisation (ICH) - Guidelines for
Good Clinical Practice
• Informed Consent
• Disclosure of clinical information
• Clinical Fraud
Practice Test
• (Intended to affirm information
discussed)
Explanation of IRBs, IECs,
and Associated Regulations
• Initial review, changes and
• continuing review
SAEs/ADRs
• Reporting requirements
• Forms
• Investigational New Drugs
Ability to Follow Directions
• Test Schedules / Study Parameters
• Dose Calculations
Abstracting Information
• Reading charts and clinical reports
• Eligibility Criteria
Conduct of Clinical Trials
• Pre-study activities
• Sponsors and research
• Responsibility of the Investigator
• Study design, phases and blinding
• Protocol Development
• Investigational Drugs, Devices,
Therapeutics and procedures
• Records retention
• Study Closure
• SAEs
• Monitoring and GCPs
• Informed consent
• Forms completion
• Audits and site visits
SOCRA designates this educational activity for a maximum of 7.5 Continuing Education Credits for SOCRA CE,
Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 7.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the
credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by
the American Nurses Credentialing Center's Commission on Accreditation. / SOCRA Course Series 500
SOCRA SOURCE © May 2023
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