Rookie Investigators Underestimate Seriousness of Signing FDA 1572s

Too many green principal investigators (PIs) blithely sign the U.S. Food and Drug Administration (FDA)-demanded Statement of Investigator (Form 1572) and run the risk of falling into serious trial deviations or even potential legal issues, warns Randall Stoltz, medical director with the Covance Clinical Research Unit in Evansville, Ind. “You have to ask what you […]

Career Tip: Invest in Your Continued Education

Carla G. Perna, BS, CCRP, recently reflected on her career and lessons learned as she advanced from research assistant to program director, and on the importance of staying on your toes. Q: What advice do you have for clinical research professionals on how to advance their careers? A: Get your degree; get certified! Pick a […]

Are Your SOPs Ready for Prime Time?

Standard operating procedures (SOPs) are the foundation for any effective clinical research program, experts agree. The U.S. Food and Drug Administration (FDA) agrees, too. It’s one of the most common areas the agency scrutinizes during an inspection. Officially, SOPs are defined by the International Conference on Harmonization (ICH) in its Good Clinical Practice Guidelines (ICH […]

Safe Clinical Trials Demand Aggressive Risk Analysis

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 […]

Tiny Regulatory Wrinkles Can Create Big Problems for Clinical Trials

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 […]