Learn best practices in utilizing sample-centric RBM components from a centralized monitoring perspective to empower your study teams with up-to-date, accurate, and actionable insights. Webinar replay expires July 25, 2018.
This webinar replay will help attendees discern and anticipate these important differences with an eye to best practices in device studies and collaborative solutions for success. Webinar replay expires June 28, 2018.
Clinical trial practitioners seeking direct U.S. Food and Drug Administration (FDA) input for specific questions can leverage an online service from the agency’s Office of Good Clinical Practice. While comprehensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights some of […]
Good clinical practice (GCP) training has become the standard for qualifying investigators to conduct clinical trials, but little evidence has been collected to determine whether this training is providing the necessary knowledge and skills, says Jennifer Goldsack, MA, MBA, CPHQ, project manager of a team conducting in-depth interviews of contract research organizations (CROs), sponsors, and […]
Lack of adequate oversight and improper delegation of authority continue to dog clinical trial operations. One or both of those problems are frequently cited by U.S. Food and Drug Administration (FDA) investigators in Form FDA 483s (“Inspectional Observations”) after inspection of a study facility, notes Mariette Marsh, MPA, CIP, director of the Human Subjects Protection […]