Clinical Trials Administrator Archives – November 1, 2010
November 1, 2010
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Research sites can improve compliance by forming centralized CT operations
Large research institutions can help clinical trial (CT) investigators and staff improve their study operations and regulatory compliance by providing clinical research staff services through a centralized office. -
Improving compliance consistency via training
Clinical research (CR) organizations should focus on two key areas when targeting compliance: First7, they should centralize their clinical trial operations or make the decentralized system more consistent; secondly, they should put more resources into CR education and training, experts say. -
Integrate best compliance practices in CR operations
Clinical trial (CT) sites need to do system-wide risk assessments of the CT process to see where they need to improve policies, procedures, and operations, says Kelly Willenberg, BSN, MBA, president of Synergism, LLC of Chesnee, SC. Willenberg works with sites to improve research compliance, including billing and program compliance services. -
Recruitment specialists can increase enrollment
Study recruitment is an increasingly difficult role that requires relationship-building work among community providers and other skills that clinical trial coordinators might lack. -
iPhone app makes trial adverse event grading more efficient, easy
Researchers and informatics specialists at The Children's Hospital of Philadelphia (CHOP) of Philadelphia, PA, have found a novel way to connect a research tool to popular telephone or hand-held computer technology, making the grading of adverse events (AEs) more efficient and faster. -
Improving site coordinator, study monitor relationship
The sponsor and sponsored site have a relationship that is tended during a study by the study coordinator and the study monitor. -
FDA beefs up safety reporting during CTs
Clinical trials now will have to report a number of safety incidents that previously were not reported, according to a final rule issued by the U.S. Food and Drug Administration (FDA).