Clinical Trials Administrator Archives – September 1, 2005
September 1, 2005
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Subjects’ decision-making capacity must be part of the selection process
Clinical trial investigators and research staff have a responsibility that goes beyond obtaining IRB approval when working with vulnerable adult populations and making certain all research subjects are capable of making decisions related to their participation in a study, experts say. -
No one-size-fits-all tool for assessing capacity
When it comes to studying vulnerable populations, investigators and clinical trial staff may have to develop their own tools or adapt existing tools to assess a persons decision-making capacity to participate in clinical trial research. -
Data review committees offer additional protection
Data review committees (DRCs) could provide an additional layer of protection for human subjects at clinical trial sites where research often involves high-risk populations or high-risk studies. -
Overcoming barriers to Hispanic participation
In the past few years, Hispanics have become the largest minority group in the United States, numbering nearly 41.3 million in the most recent U.S. Census estimates. -
Compliance Corner: University makes effort reporting more consistent
Administrators at East Carolina University in Greenville, NC, decided three years ago to use a web-based, automated effort reporting system to replace the outdated paper-based system, and bids were requested. -
FDA senior advisor discusses GCP goals
What is the FDAs most important focus these days with regard to the clinical trial industry?