Clinical Trials Administrator Archives – November 1, 2011
November 1, 2011
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Research sites should update their disaster preparedness
As the past year's devastating tornadoes, unexpected flooding, and other disasters have shown, it is impossible to predict when and where a natural disaster might interrupt a city's business as usual. -
Risks of managing data in the cyber cloud age
Clinical research sites impacted by hurricanes, flooding, or other disasters a decade ago faced daunting challenges in retrieving files and irreplaceable study data because they either relied on paper or were early in the transition to electronic files. -
Common Rule tissue changes elicit objections
One of the more controversial proposed changes to the research Common Rule involves strengthening informed consent protections related to research involving biospecimens. Some researchers predict these changes could shut down much of their work and result in major collateral damage to the research enterprise. -
Organizations add input on IC with biospecimens
National research organizations and individual researchers have weighed in on the government's proposed changes to the Common Rule, saying regulators should reconsider their plans for requiring informed consent for all biospecimens. -
Best Practices Spotlight: Be a nitpicker when it comes to IC form details
Thirty seconds is all it might take to prevent a weeks-long regulatory hassle. That's what Eunice Newbert, MPH, tells clinical trial staff at Children's Hospital Boston (MA), where she is the manager of education and the quality improvement program. -
Be cautious when asking guardians to sign IC forms
Research sites need to be especially cautious about signatures when they work with children or other populations that are unable to provide informed consent and must have a guardian or legal representative sign the IC form, an expert advises. -
Collecting site metrics; do you know what they say?
Sponsors, clinical research organizations (CROs), and others increasingly are collecting site-level metrics, along with other data pertaining to clinical research performance. If clinical trial sites are not finding out what their metrics show, then they're missing a good opportunity to improve their operations.