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Publications
Description of Publications
Past Topics in Focus Articles
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
- Study Guide for Clinical Research Certification Examination
- 21 Code of Federal Regulations – Parts 11, 50, 56, 312, 812
- 45 Code of Federal Regulations- Part 46
- Sample regulatory forms from FDA
- The Nuremberg Code
- The Belmont Report
- Declaration of Helsinki
- Health Canada Information
- FDA Information Sheets for Clinical Investigators
- ICH GCP Guideline for Good Clinical Practice (E6)
- ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
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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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