Michael Hamrell headshot

QA Q&A Corner: The Mysterious and Sometimes Maddening Form FDA 1572

In this issue's column, the questions raise a number of issues regarding the use of the U.S. Food and Drug Administration (FDA) Form 1572, otherwise known as the "Statement of Investigator" form. Although the form has been in use for many years, it continues to generate a variety of Good Clinical Practice (GCP) compliance–related questions. […]

Paula Smailes headshot

Guest Editor’s Message: The Necessity of Workforce Development for Clinical Research Professionals

Jim Kremidas, executive director of the Association of Clinical Research Professionals, has stated that, due to the lack of a standardized path into the clinical research enterprise, there is a "tremendous amount of variance in research conduct, processes, and workforce competence, which culminates in a detriment to research quality."1 His statement hits home […]

ACRP to Release First Ever Harmonized Core Competency Framework for Clinical Trial Monitors

Framework to Define Competence Requirements for Monitors/CRAs Working in Clinical Research

The Association of Clinical Research Professionals (ACRP) today announces plans to release a harmonized Core Competency Framework for Clinical Research Associates (CRAs) in December that for the first time ever will define the core competencies required of clinical trial monitors/CRAs within the […]

Digital Technology

Survey: Digital Tech Use Up in Clinical Trials, But Concerns Remain

Nearly 98% of clinical research professionals plan to use digital technologies to collect patient data within the next five years, according to a study of 166 biopharma and life sciences industry researchers, executives, and technology/software professionals conducted by Validic. Broadly speaking, the study’s findings highlight how digital technologies will become significantly more important in the […]