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Data Collection Forms in Clinical Trials

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Spilker Bert, Schoenfelder John. . 688 pages. New York: : Raven Press; ; 1991.. $90.00.

Ann Intern Med. 1991;115(9):752. doi:10.7326/0003-4819-115-9-752_1
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An exhaustive collection of sample forms relevant to all aspects of data collection in clinical trials: "background" data such as medical and medication histories; exclusion and inclusion criteria; data from examinations (physical, psychometric) and laboratory tests; adverse events; drug, efficacy, and compliance data; terminations; visits; and so on. Perhaps even more valuable than the sample forms are the opening sections on guidelines to be considered in designing forms and pointers on how to minimize confusion and error. There are also practical suggestions on assembling, packaging, distributing, and storing forms.


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