Clinical Trials Administrator Archives – December 1, 2003
December 1, 2003
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Advertising may be cost-effective, but liability lurks in the wording
You cant have a clinical trial without volunteers, and clinical trial coordinators and investigators often find that recruiting human subjects takes some creativity. Enter advertising. -
Advertising Do’s and Don’ts
So what should an advertisement recruiting trial subjects say? W. Parker Nolen, MBA, IRB administrator for St. Josephs Hospital in Atlanta, recommends the following: -
College students: Are they a captive audience?
To clinical trial coordinators looking for study subjects, a nearby university campus looks like a godsend large numbers of unemployed young people all in one place for a designated period of time. -
Numbers indicate misconduct rising
Research misconduct activity reported by institutions in 2002 reached the highest levels since 1997, according to a report in the quarterly newsletter from the Department of Health and Human Services Office of Research Integrity (ORI). -
HIPAA authorizations don’t require IRB review
IRBs are not required to review stand-alone HIPAA waivers as part of their oversight of research subject protections even if their written policies and procedures indicate they will review any written documentation provided to potential study participants, the U.S. Food and Drug Administration (FDA) clarified in a recent guidance document issued Oct. 21, 2003, and published in the Nov. 7 issue of the Federal Register. -
Integrated systems keep all connected
Its pretty much a given that computer-based recordkeeping will play a part in a clinical trial. -
News Briefs
Hastings Center issues report on reprogenetics; NIH expanding distance learning programs