Marti Arvin, Vice President of Audit Strategy, Cynergistek

Privacy and Information Security Issues in Clinical Research 

Clinical Researcher—March 2018 (Volume 32, Issue 3) PEER REVIEWED Marti Arvin, JD [DOI: 10.14524/CR-18-0001]   Organizations engaged in clinical research have a number of complex regulations to follow to ensure compliance, with one particularly challenging area of regulations being privacy and information security. Key to understanding the implications of privacy and information security in research […]

Michael Causey, ACRP Editor-In-Chief

Privacy, Prejudice, and Participation

Clinical Researcher—March 2018 (Volume 32, Issue 3) SPECIAL FEATURE James Michael Causey; Gary W. Cramer [DOI: 10.14524/CR-18-4020]   Whether it’s via data posted to Facebook, Instagram, or LinkedIn, or shared through e-mails or electronic personal profiles filled out with service providers, clubs, networking venues, or employers, never have so many freely offered up so much […]

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Sponsors Weigh in on Proposed FDA Patient-Focused Drug Development Guidance

The jury is still out for drug manufacturers when it comes to the U.S. Food and Drug Administration’s (FDA’s) parameters for its in-progress, patient-focused drug development guidance. However, the steady stream of early industry comments skews mostly positive. FDA says it will unveil additional draft guidances on patient-focused drug development over the next four years, […]