|















|
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
- 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.
Back
to Top
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
Back to Top
|