Comments submitted regarding Scientific guidance on post-authorisation efficacy studies. (Identifier: EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015). Click here to read the comments and impact on ACRP Members.
Assessing risk in advance is the key to running a safe, successful clinical trial, says Peggy Fay, PhD, RN, CCRC, a clinical research consultant with Clinical Research Facilitators in Buford, Ga. The stakes are high. She recently worked on a trial where the sponsor and team did everything right—except consider the possibility the product wouldn't […]
Beware the 234,812-word federal regulation bearing gifts. Even if a new law wasn’t intended to cover clinical research, it can still sneak up and impact the way sites do business, says David Vulcano, LCSW, MBA, CIP, RAC, with HCA (Hospital Corporation of America) in Nashville, Tenn. “Sometimes, the word ‘research’ isn’t even in a federal […]
Today’s clinical research associates (CRAs) have some justification if they feel like superstar college athletes nailing down big signing bonuses. They should enjoy it while they can. The job landscape of the future could be quite a bit different, says Jeff Kasher, president of Patients Can’t Wait LLC. Thanks to risk-based monitoring (RBM) (see the […]
The Association of Clinical Research Professionals (ACRP) today announces a major initiative to promote and validate competence in clinical research. Starting in 2017, ACRP’s industry-leading certification programs will be harmonized with the core competency framework developed by the Joint Task Force (JTF) for Clinical Trial Competency, whose contributors and collaborators include leading organizations representing clinical […]