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Description/Overview

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Product Accountability (DA) is a Findings domain used to collect information about the dispensing and returning of

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investigational products used in a

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study.

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The SDTMIG separates drug accountability from the Exposure (EX) domain, which contains the data about the subjects' actual exposure to study treatment. Per the SDTMIG, Drug Accountability is "a findings domain that contains the accountability of study drug, such as information on the receipt, dispensing, return, and packaging." The Exposure (EX) domain 

contains the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.

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Findings domains are typically represented in the vertical/normalized structure, which is usually the easiest and quickest way to collect, process, and clean data. However, users may have system constraints that prevent them from collecting data in the vertical/normalized manner. In such cases, the horizontal/denormalized version provides the structure necessary to collect the variables in another way.

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

Care should be taken not to confuse

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product accountability with study

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product compliance or study

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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

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

Because the actual

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product name may not be known to the site at the time of dispensing or returning, the

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word product  in the context of the CDASHIG DA domain refers to the identifier that references the

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product  (e.g.,

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Product  A,

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Product B,

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)  rather than the actual (unblinded)

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product name.

The term dispensed

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refers to when the

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product is provided to the subject, not when the subject uses or consumes the study

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product. The term returned

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refers to when the subject returns the unused study

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product to the investigational site.

In some cases sponsors may wish to link DA data to EX data. This may be accomplished by using the appropriate identifier variables and the relationship (RELREC) dataset as described in the SDTMIG.

The CDASHIG DA domain is modeled in both normalized and denormalized structures to provide users with examples of how each structure could be implemented. Findings domains are typically represented in the vertical/normalized structure, which is usually the easiest and quickest way to collect, process, and clean data. However, users may have system constraints that prevent them from collecting data in the vertical/normalized manner. In such cases, the horizontal/denormalized version provides the structure necessary to collect the variables in another way.

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

Specification

Assumptions

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