The SoCRA SOURCE Journal

Journal Overview

Submitting an Article for The SoCRA SOURCE

Journal Ad Insertion Order Form

Journal Articles

Overview

The SoCRA Source journal is published in February, May, August, and November. Ads must be submitted by December 1 (for February), March 1 (for May), June 1 (for August), and September 1 (for November). The SoCRA Source is mailed to over 6,300 SoCRA members each quarter.

Please submit digital files, use PDF (preferred - ensure that all fonts are embedded), Jpeg, Tiff or EPS, or supply camera-ready copy (paper slick) or film of the appropriate size. Color ads must be High Resolution CYMK.

Full-page ads must fit a 7¼" x 9" layout, half-page 3½" x 9" or 7¼" x 4½ ", and quarter page ads must fit a 3½" x 4½" layout. Half page ads may be presented in horizontal or vertical form.

Full Page Ad (Color) $900.00

Full Page Ad (B/W) $700.00

½ Page Ad (B/W) $400.00

If your ad requires resizing or typesetting, add $100.00

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Submitting an Article for The SoCRA SOURCE

Submission Process for Permission to Publish Regulatory, Scientific and Technical Articles

• Articles should be of a regulatory, scientific or technical nature.
• Article containing errors in grammar or spelling will be returned to the author for additional editing.
• Articles promoting software, services, or other products will be considered advertising and will not be published (see journal advertising).
• Articles should be submitted in Microsoft WORD, include a short abstract, no special formatting, all tables following the article in sequence, no lines or special margins, and any pictures should be submitted separately.
• Author must certify that their submitted or transcribed article is an original work and has no prior ownership or copyright restrictions.
• Author must certify that the article is not previously copyrighted.
• Author must give SoCRA authority to reproduce and publish the article.
• If any other individual or organization asks for or receives copyright privileges for the work, the author must certify that SoCRA will be promptly notified.
• Author must hold SoCRA harmless from any breach of this warranty.

The SoCRA SOURCE Article Submission Form is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software)

Click Here to view/print the SoCRA SOURCE Article Submission Form in Adobe PDF Format.

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Journal Ad Insertion Order Form

The Journal Ad Insertion Order form is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software)

Click Here to view/print the Journal Ad Insertion Order form in Adobe PDF format.

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Journal Articles

The Journal articles listed below are available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software)

May, 2004 Issue

• Self Study: Title 45 Code of Federal Regulations, Part 46 (46.301and 46.409): Protection of Human Subjects: Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) (PDF) (582 KB)
• Ethics in Clinical Research - A History of Human Subject Protections (PDF) (782 KB)
• Web-based Education and Training by Stefanie Davis, IRB Administrator (PDF) (413 KB)
• The Paper Trail: CRFs, Source Documents, and Data Collection Tools by Donna Headlee, RN, BSN, CCRP
• Informed Consent: An Important Obligation Involving Hidden Issues by William Hirschhorn, MS and Fouad Ghannam, Pharm.D. (PDF) (539 KB)
• FDA Inspector Perspectives: GCPs and Inspections of Clinical Investigators and Sponsors by Ronald L. Koller, Investigator, Los Angeles District, U.S. Food and Drug Administration (PDF) (421 KB)

February, 2004 Issue

• Self Study: Title 45 Code of Federal Regulations, Part 46 (46.201and 46.211): Protection of Human Subjects: Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) (PDF) (582 KB)
• Current Challenges in Clinical Trial Patient Recruitment and Enrollment by Genevieve Frank, CRA (PDF) (434 KB)
• Phase 1 Study of Intrathecal Spartaject™ Busulfan in Patients with Neoplastic Meningitis by Kara L. Penne, RN, BSN (PDF) (1.3 MB)
• Financial Assistance and Incentives for Research and Development of New Drug and Biological Products by Ronald Wilson, Director, Small Business Assistance Center for Drug Evaluation and Research U.S. Food and Drug Administration (PDF) (1.6 MB)
• Principles of Forms Design and Interviewing for Data Collection by Phyllis L. Pirie, Ph.D. (PDF) (509 KB)
• Of Plagues, Blights, and Bloodletting: Historical Highlights of the Randomized Controlled Trial by Mary Lou Greenfield, RN, MPH, MS (PDF) (498 KB)
• From Stents to Scanners: Adventures in Coordinating and Monitoring Device Clinical Trials by Robin Newman (PDF) (3.2 MB)

November, 2003 Issue

• Self Study: Title 45 Code of Federal Regulations, Part 46 (46.112 and 46.124): Protection of Human Subjects: Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) (PDF) (394 KB)
• How to Grow Your Investigative Site by Barry Miskin, MD (PDF) (276 KB)
• Bilateral Prophylactic Mastectomy: Efficacy, Satisfaction, and Psychosocial Function by Marlene H. Frost, RN, Ph.D., AOCN® (PDF) (281 KB)
• Sure I Have Diabetes, So What? by Lori D. Berard , RN, CCRC (PDF) (333 KB)
• Assessing the Clinical Significance of Quality of Life (QOL) Measures by Jeff A. Sloan, Ph.D. (PDF) (273 KB)
• What Is The Role of The Project Manager in A CRO? by Kim M. Boericke, Senior Director, Global Project Management (PDF) (291 KB)
• Institutional Review Boards: Foundations in Law (PDF) (281 KB)
• Readability and Language of Informed Consent by Mark Hochhauser, PhD (PDF) (303 KB)

August, 2003 Issue

• Self Study: Title 45 Code of Federal Regulations, Part 46 (46.103 and 46.111): Protection of Human Subjects: Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) (PDF) (599 KB)
• Herbal Medicine: The Good, The Bad, and The Ugly by Brent A. Bauer, MD (PDF) (427 KB)
• PDAs and Clinical Data Management by Yvonne Stolworthy, RN, BScN, CCRP (PDF) (517 KB)
• Automation of Information Management by Michael Montello PharmD (PDF) (464 KB)
• Conflicts of Interests and Threats to the Conduct of Clinical Research by Ruth L. Fischbach, PhD, MPE (PDF) (478 KB)
• GCP Compliance Problems Encountered At Clinical Sites - Informed Consents, Physical Exams, and Adverse Events by Vernette J. Molloy, MBA, RN and Douglas R. Mackintosh, DrPH, MBA, GCPA (PDF) (640 KB)

May, 2003 Issue

• Self Study: Title 45 Code of Federal Regulations, Part 46 (46.101 and 46.102): Protection of Human Subjects: Subpart A - Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects) (PDF) (1.3 MB)
• Investigator-Initiated Clinical Trials Development, Conduct, and Management by Yuka Sato, BPharm, MS, CCRP (PDF) (1.2 MB)
• Device Clinical Trials - Regulatory Considerations by Michael E. Marcarelli, Pharm.D. (PDF) (412 KB PDF)
• Recruitment and Retention of Patients / Site Management by Russell V. Luepker, MD, MS (PDF) (697 KB)
• The HIPAA Privacy Rule and Research (PDF) (298 KB)
• Investigative Site Budget Tool Part 1 of 2 (PDF) (1.6 MB) by Guy P. Johnson, CPA, MS
• Investigative Site Budget Tool Part 2 of 2 (PDF) (1.6 MB) by Guy P. Johnson, CPA, MS

February, 2003 Issue

• Self Study: ICH Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance: Part 7. INVESTIGATOR’S BROCHURE, Part 8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL (PDF) (368 KB)
• 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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