Clinical Trials Administrator Archives – October 1, 2010
October 1, 2010
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Take a risk management view of data compliance, cleaning
Often overshadowed by other pressing clinical research needs, the detailed, difficult process of data management is drawing closer scrutiny by the Food and Drug Administration, researchers are finding. -
Data cleaning can have big impact on trials
Clinical trial data increasingly is collected and communicated electronically. Sites often are dependent on how sponsors and clinical research monitoring organizations set up their data collection and editing systems, but there are issues they can prevent through better processes and preparation. -
Best Practices: Crucial steps to ensure good clinical practice
The first step in improving a clinical trial site's good clinical practice is to make certain all informed consent processes and documentation are followed with exacting care. -
Avoiding little mistakes — and bigger problems
In clinical research documentation, the little things definitely count and often could lead to major regulatory problems. -
Keep communication open to motivate CR staff
Clinical research (CR) directors who hope to improve staff retention and motivation might begin by keeping the lines of communication open with principal investigators, clinical trial coordinators, and the rest of the research team. -
Hire study coordinators that fit your work culture
Most work environments contain at least one example of clashing personalities or a problematic worker attitude. -
The outsourced IRB: A successful case study
Research institutions continually look for ways to make their operations more efficient, especially during lean economic times.