A Closer Look at FDA’s Proposed Rule on Informed Consent Waivers

Clinical Researcher—February 2019 (Volume 33, Issue 2) SPECIAL FEATURE Robert Barton       The U.S. Food and Drug Administration’s (FDA’s) proposed rule to allow an institutional review board (IRB) to waive or alter informed consent requirements in low-risk clinical trials is a good step toward streamlining the approvals process for drugs and medical devices, […]

GDPR and U.S. Clinical Trials: What is the Impact?

Clinical Researcher—February 2019 (Volume 33, Issue 2) DATA-TECH CONNECT Esther Daemen, MBA; Tine Wouters, MSc       The General Data Protection Regulation (GDPR) (2016/679) brought about the greatest change to European data security in 20 years. Applicable since May 2018 and repealing the Directive 95/46/EC, GDPR intends to strengthen and unify data protection for […]

Applauding the Clinical Research Workforce

Clinical Researcher—February 2019 (Volume 33, Issue 2) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas       Clinical research is a valuable profession, and it deserves to be treated as such. Whether the members of its workforce are saving lives, alleviating suffering, or helping people live healthier, more active lives, it is difficult to think of a […]

Off to the Races

Clinical Researcher—February 2019 (Volume 33, Issue 2) CHAIR’S MESSAGE John P. Neal, CRCP     We’ve had a strong start out of the gate for 2019, and the year ahead looks good for ACRP. In January, we held the year’s first ACRP Association Board of Trustees (ABoT) meeting at ACRP headquarters in Alexandria, Va. After […]