November 2024 SOCRA Source Journal - Journal - Page 90
SOCRA Clinical Research Professional
Certi昀椀cation Preparation and GCP Review Course
VIRTUAL
NOVEMBER 18 & 19, 2024 | VIRTUAL
DECEMBER 10 & 11, 2024 | VIRTUAL
Workshop registration fee: $295 (Non-member $370 - includes one year’s membership)
Goal: The Society of Clinical Research Associates (SOCRA) recognizes Certi昀椀ed Clinical Research 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 Certi昀椀ed 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
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 Practices (GCP)
• Explain the elements of informed consent
• Describe the membership and reporting requirements of IRBs
• Explain rules relating to 昀椀nancial disclosure
• Discuss the basic rules 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
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 af昀椀rm 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 6.5 (in-person) or 7.5 (virtual)
Continuing Education Credits for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 6.5 (in-person) or 7.5 (virtual) 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
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SOCRA SOURCE © November 2024
