Stephen A. Sonstein, PhD, Chair of the CAAHEP’s Committee on Accreditation of Academic Programs in Clinical Research

Joint Task Force Vies for ACRP Innovation in Workforce Development Award

Competency, not tenure, should be the litmus test for clinical trial professionals, a growing number of experts agree. The challenge is developing and promulgating such standards. That’s where the Joint Task Force for Clinical Trial Competency (JTF) comes in. With the JTF being one of three finalists for the ACRP Innovation in Workforce Development Award, […]

IRBs Play Waiting Game with Revised Common Rule Implementation

Clinical Researcher—April 2018 (Volume 32, Issue 4) SPECIAL FEATURE Matthew Harrington [DOI: 10.14524/CR-18-4022]   Sometimes it pays to procrastinate. Institutional review boards (IRBs) that put off the work needed to comply with the revised Common Rule got a reprieve in January when compliance was delayed by six months.1 Just two days before the new rule […]

An IRB Perspective on Improving Informed Consent

Clinical Researcher—April 2018 (Volume 32, Issue 4) PEER REVIEWED Julie Blasingim, MBA, CIP; Sandra “SAM” Sather, MS, BSN, RN, CCRC, CCRA [DOI: 10.14524/CR-18-0003]   The informed consent process is essential to the ethical conduct of research on new medicinal products, therapies, and approaches to improving healthcare. The investigator can use various tools to optimize this […]

ICH E6(R2) and Data Integrity: Four Key Principles

Clinical Researcher—April 2018 (Volume 32, Number 4) ICH IN FOCUS Michael Rutherford, MS [DOI: 10.14524/CR-18-4021]   A few months prior to the release of the updated International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)),1 three draft guidance documents on the topic of “Data Integrity” and an explanatory Q&A document were published […]