Clinical Trials Administrator Archives – February 1, 2006
February 1, 2006
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Electronic grammar check doesn’t ensure consent process effectiveness
The informed consent process has become much more complicated and burdened with legalistic language in recent years, and there is little research available to show what the impact is on subjects understanding of their role in studies, experts say. -
Tips on improving the consent document
Its not necessary to conduct a major research project each time a new informed consent form is written, but its only sensible to obtain the readability perspective from someone who is not familiar with the protocol vocabulary, an expert suggests. -
Bioethics committee weighs in on continued drug use
Whether investigators are conducting pharmaceutical research domestically or overseas, there always is a question about what will happen to subjects when the study ends. There are a variety of ethical questions regarding whether its better to continue to provide access to a study drug or whether its best to let the access end with the trial. -
Fill often overlooked site education gap
Research institutions and clinical trial sites often pay close attention to investigator training, particularly to whats required through regulations and institutional policies. But an important educational opportunity often is overlooked, and that involves the training of research coordinators. -
Award-winning training program available to all
Clinical trial sites and research institutions seeking improvements to their staff and IRB training programs might learn something from the best practices developed by Family Health International (FHI) of Research Triangle Park, NC. -
Research training trends and methodologies
Requirements for research staff education may not include hard and fast regulations, but they might be part of the expectations held by regulators, sponsors, and others in the research industry.