FDA Commissioner Scott Gottlieb, MD

FDA Updates Expanded Access Program

In a renewed effort to advance clinical trial options for medical products for patients with serious or immediately life-threatening diseases, the U.S. Food and Drug Administration (FDA) announced last week it will begin implementing suggestions it has received to enhance its Expanded Access program. Sometimes called “compassionate use,” Expanded Access is a pathway through […]

Develop a Comprehensive Learning Needs Assessment for Your Research Staff

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Tracy Graham, RN, BSN, CCRC   Targeted continuing education for research staff is an important component of any research program. Continuing education that is meaningful to research staff promotes professional development and improves the quality of research. The foundation of a successful continuing education plan is […]

The Necessity of Clinical Research Documentation Training Programs and the Value of Learning from Mistakes

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Paula Smailes, DNP, RN, CCRP, CCRC   Source documentation lies at the heart of clinical research workflows for investigative sites. Adequate documentation of protocol-related visits ensures that required information on study conduct and results has been captured for sponsors and other stakeholders.{1} In the clinical research […]

Applying Lean Methodology to Improve the Informed Consent Process

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Melissa Kadar; Lindsey Sikora, RN   In 1978, the Belmont Report{1} was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published in the Federal Register. This important document outlines three fundamental ethical principles and guidelines for conducting […]

Efficacy of Technology Training and the Need for Optimization

Clinical Researcher—November 2018 (Volume 32, Issue 9) DATA-TECH CONNECT Paula Smailes, DNP, RN, CCRP, CCRC   The theme for Clinical Researcher this month is training, and when we look at all the various types of technologies that clinical research staff use in a given day, the expectations for their abilities—trained or untrained—to use these tools […]