You need to be more specific ... as in the drug, time involved in the study, what it is you're trying to determine, etc. Can't answer the question with no information other than what you've written.
As a general rule audits would be the same as for anything else. The law of large numbers applies as does the use of some placebo doses vs the real drug. We need more info to help you I think.
Are you involved in a clinical trial of some kind? They help determine how a drug will work for the majority of people in similar and differing circumstances. God bless. : )
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