Ethics, Consent, and Controlled Clinical Trial
JAMA: The Journal of the American Medical Association 1966 November 7; 198(6): 637-638
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Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group Coyne, Cathy A.; Xu, Ronghui; Raich, Peter; Plomer, Kathy; Dignan, Mark; Wenzel, Lari B.; Fairclough, Diane; Habermann, Thomas; Schnell, Linda; Quella, Susan; Cella, David (2003-03-01)
Can User Testing of a Clinical Trial Patient Information Sheet Make It Fit-for-Purpose? -- a Randomized Controlled Trial Knapp, Peter; Raynor, David K; Silcock, Jonathan; Parkinson, Brian (2011-07-21)The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not ...