FDA Logo

FDA Mailbag: Agency Addresses Monitoring, Study Close Out Concerns

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 extensive, it is an often-overlooked and cumbersome data repository. In this occasional series, ACRP wades through the posted questions and answers and provides highlights from some of […]

ClinTrials.gov Logo

ClinicalTrials.gov Revamps Website

For the first time since 2012, the National Library of Medicine (NLM) is set to unveil major upgrades to its popular ClinicalTrials.gov website. The website provides patients, family members, healthcare professionals, researchers, and the general public easy access to information on current and pending trials. As of May 25, it listed 245,000 clinical studies covering […]

Laura LaRosa, RN, MS, President, Sheldon Clinical Trials Consulting, Inc.

Is CRA Fraud Undermining Clinical Trial Integrity?

Nearly 85% of clinical research associates (CRAs) were fraudulently documenting informed consent during a Phase III trial involving more than 100 sites, according to an observational study of several clinical trials conducted by Laura LaRosa, RN, MS, president of Sheldon Clinical Trials Consulting, Inc. “I think [some form of clinical operations documentation fraud] is happening […]

Rare Disease Activist Simon Ibell

Rare Disease Activist Simon Ibell Remembered for Inspiration, Bravery

Activist and speaker Simon Ibell, 39, died peacefully in his sleep on Friday, May 26, according to his brother-in-law Cameron Gilbert. Ibell, founder and CEO of the iBellieve Foundation, was a crusader in the rare disease community. As one of 30 people in Canada and approximately 2,000 worldwide born with a condition known as MPS […]

NIH Logo

Feds Eye Committee to Promote Individual-Specific Research

A new study set in motion by the National Institutes of Health (NIH), in collaboration with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), hopes to create a committee to review and evaluate the return of individual-specific research results from research laboratories. The study will be conducted by […]