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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.
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The adolescent in your exam room just told you she had unprotected sex over the weekend. When you ask her if she used emergency contraception (EC), she says she didnt know where to get a prescription because the clinic was closed.
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Look for new developments this year when it comes to male contraception. While it may be some time before an actual product reaches the market shelves, scientists are gaining ground in the development of possible forms of birth control for men.
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A quick check of your next patient chart shows a woman with irregular or absent ovulation and elevated levels of androgenic hormones. Whats your initial diagnosis?
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Wilke AJ. News Briefs. Altern Ther Women's Health 2004;6(8):64.
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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.
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So what should an advertisement recruiting trial subjects say? W. Parker Nolen, MBA, IRB administrator for St. Josephs Hospital in Atlanta, recommends the following:
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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.
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Its pretty much a given that computer-based recordkeeping will play a part in a clinical trial.
