Publications

Description of Publications

Past Topics in Focus Articles

Description of Publications

SoCRA provides its members with the following publications.

• SoCRA Source Journal - Quarterly Publication
  • Scientific Articles
  • Newsworthy Professional Articles
  • Society News and Events
  • Opportunities and Services

• Certification Program Reference Manual for Clinical Research Certification Examination

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• Sample regulatory forms from FDA
• ICH GCP Guideline for Good Clinical Practice (E6), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• Health Canada Information

Click here to download a copy of the Certification Program Reference Manual Purchase Request Form.

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Past Topics in Focus Articles

• Recruitment and Retention of Patients / Site Management by Russell V. Luepker, MD, MS (697 KB)
• The HIPAA Privacy Rule and Research 
• Investigative Site Budget Tool (PDF) (1.6 MB) by Guy P. Johnson, CPA, MS
• Investigative Site Budget Tool Part 2 (PDF) (1.6 MB) by Guy P. Johnson, CPA, MS
• The Role of Data Monitoring Committees and Their Impact on Clinical Research Associate Responsibilities (PDF) (294 KB) by Bryan Matthews, School of Nursing, Duke University
• Lay Lab Language for Informed Consents (PDF) (259 KB) by:
  • Karen G. Davenport RN, BSN, CCRC
  • Lori Ratliff MSN, ANP, CCRC
  • Gloria A Carter LPN, CCRP
  • Harriette Wheatley RN, BSN, CCRC
  • Wendie Price, RN, CRC
  • University of Virginia School of Medicine
• ERES Compliance and Data Integrity Issues in e-Trials (PDF) (317 KB) by Claudia Goggin Fredian, RN, BSN, CCRP
• Clinical Research in The Community Hospital (PDF) (266 KB) by Claudia Goggin Fredian, RN, BSN, CCRP
• End of Life Issues in Clinical Research (PDF) (277 KB) by Pamela Hinds, PhD, RN, CS

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