Clinical Trials Administrator Archives – June 1, 2011
June 1, 2011
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Smaller sponsors may beget better data and metrics
The clinical research industry's well-documented inefficiency is like a rhinoceros stampede: everyone recognizes it, regrets it, but can't figure out how to stop it. -
CRO uses site data when new studies begin
Cato Research, a clinical research organization (CRO) in Durham, NC, maintains a database and metrics on all studies, continually comparing sites' predicted study enrollment with their actual performance. -
Focus on QA results in better informed consent
Research institutions put considerable time and resources into developing informed consent (IC) templates and tools to assist researchers as they seek ethics board approval, but they sometimes neglect to focus on the part that describes cost to participants. -
Vanderbilt's cost flow template abets studies
The human research protection program at Vanderbilt University of Nashville, TN, has created a flow chart that assists investigators with making decisions about how to insert cost language in study informed consent forms. -
Communications expert: speak no 'medicalese'
After years of training that results in physicians and researchers speaking in a way that is at best challenging for patients to understand, they now can learn how to talk like a layperson. -
PRISM creates guide for improving IC readability
The PRISMProject to Review and Improve Study Materialshas developed a quick reference guide for improving readability in informed consent and other research documents. -
Improving compliance by focusing on 7 factors
Research institutions might begin any new or improved compliance program by following the seven elements of an effective compliance program that are part of the Office of Inspector General (OIG) compliance guidance for hospitals, an expert advises. -
Compliance checklist grants review constancy
The regulatory compliance office at Children's Medical Center of Dallas, TX, has developed a comprehensive, 14-page research compliance checklist that is used to review all studies. -
OIG's 7 elements for effective compliance
When initiating or improving a research institution's compliance program, the most efficient place to start is to follow federal guidance on such programs, including compliance program guidance created by the he U.S. Department of Health and Human Services' Office of Inspector General (OIG).