GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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20:46 Mar 26, 2007 |
German to English translations [PRO] Medical - Medical (general) | |||||||
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| Selected response from: Patricia Daehler United States Local time: 11:23 | ||||||
Grading comment
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Summary of answers provided | ||||
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3 +8 | informed consent discussion |
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3 +1 | (face-to-face) consultation |
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informed consent discussion Explanation: ... as opposed to the written informed consent form of your other question. Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following: (a) That the trial involves research. (b) The purpose of the trial. (c) The trial treatment(s) and the probability for random assignment to each treatment. (d) The trial procedures to be followed, including all invasive procedures. (f) Those aspects of the trial that are experimental. (s) The expected duration of the subject's participation in the trial. http://www.irbforum.com/documents/documents/FDAvICH50.rtf |
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Grading comment
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