When explaining the probability of assignment to trial arms in consent forms, which is true? A. FDA requires the probability to be expressed as a percentage chance. B. The use of a placebo arm does have to be specifically stated, but not the chance of assignment. C. ICH notes that it should be included, but does not specify how the information should be presented. D. The probability of assignment should always be stated as being "like the flip of a coin" because subjects can understand that example

Question

Shyla Washington

Biology

7 October, 14:04

When explaining the probability of assignment to trial arms in consent forms, which is true? A. FDA requires the probability to be expressed as a percentage chance. B. The use of a placebo arm does have to be specifically stated, but not the chance of assignment. C. ICH notes that it should be included, but does not specify how the information should be presented. D. The probability of assignment should always be stated as being "like the flip of a coin" because subjects can understand that example

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Mayra · Answer 1

C. ICH notes that it should be included, but does not specify how the information should be presented

Explanation:

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a unique institution that has as an objective the fact to bring regulatory and pharmaceutical authorities together in order to discuss scientific and technical aspects of drug registration. It started in the year 1990 and currently it counts on 16 members and 32 observers.