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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 […]

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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 […]