Jennifer Goldsack, MChem, MA, MBA, CPHQ, Project Manager, Clinical Trials Transformation Initiative

CTTI Challenges Current Investigator Training Regimen

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 […]

Mariette Marsh, MPA, CIP, Director, Human Subjects Protection & Privacy Program, University of Arizona

PIs Struggle with Increasingly Complex Oversight Demands

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 […]

Draft Guidance Provides Direction on eRecords, eSignatures, eSystems, and More

FDA Draft Guidance Spells Out New Part 11 Expectations

An important new draft guidance from the U.S. Food and Drug Administration (FDA) proposes enhanced direction on how to manage electronic records (erecords) and electronic signatures (esignatures) in clinical investigations, how to validate electronic systems (esystems), and how to implement audit trails for erecords. The full draft guidance released on June 21, “Use of […]