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Depending on the study design, the DA CRF/eCRF may not be required.

Care should be taken not to confuse product accountability

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with study

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product compliance or study product  exposure. Comparing the amount dispensed to the subject and the amount returned by the subject does not necessarily mean the difference equates to the amount of

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consumed by the subject or the subject's compliance

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.  For example, the subject could have misplaced some of the

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product and thus the return amount could provide a false estimate of compliance.

Because the actual product name may not be known to the site at the time of dispensing or returning, the word product  in the context of the CDASHIG DA domain refers to the identifier that references the product  (e.g., Product  A,

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Product B,)  rather than the actual (unblinded) product name.

The term dispensed refers to when the product is provided to the subject, not when the subject uses or consumes the

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study product. The term returned refers to when the subject returns the unused study product to the investigational site.

Specification

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