Clinical Trials Administrator Archives – March 1, 2010
March 1, 2010
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Balancing act: Reducing regulatory burdens without increasing risks
It might seem too daring to make changes to human subjects oversight programs by easing ethics review procedures. But several research organizations have found that some measured changes can help reduce investigators' regulatory burden without increasing risk to subjects. -
Ebbing the tide: PIs fight "mission creep"
Review board mission creep: nearly every research organization experiences it, and most clinical trial sites resent it. -
Small research institution has some big tips
Research sites can improve the way they handle regulatory requirements and encourage more investigators to conduct research by making simple changes, an expert says. -
Compliance Corner: Checklists, tools, help site manage QA/QI reviews
Increasing numbers of research institutions have opened offices to provide oversight of investigator-initiated clinical trials, but they often lack the basic tools needed for this process. -
Institution's reviews proactive, educational, and boost compliance
The University of Pittsburgh in Pittsburgh, PA, has developed a thorough, review process that serves as an educational opportunity, as well as a way to prevent clinical research problems. -
Oncology survey finds optimism, cost concerns
Oncologists and medical directors say that 38% of their patients could benefit from participation in clinical trials, but only about 5% actually enroll in an oncology study per month, according to a recent survey. -
Improve your research contract, negotiation skills
Each clinical trial administrator and investigator needs to understand the motivations of all parties involved including his or her own before beginning a clinical trial contract negotiation process.