Drug Accountability - Horizontal & Vertical

The CDASHIG DA domain is used to collect information about dispensing and returning of study treatment materials used in a clinical trial.

The term dispensed refers to when the study treatment is provided to the subject, not when the subject uses or consumes the study treatment. The term returned refers to when the subject returns the unused study treatment to the investigational site.

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.

See the CDASHIG for additional information about the DA domain.

In these CRFs, the unit lists have been subsetted and alphabetized. The user should determine the appropriate items and order per the protocol.

If the EDC system has hover text available: Treatment Label Identifier = Kit Number.

Three CRFs are provided for download: one vertical structure (in preview) and two horizontal structure.

"Form DA - Implementation Options: Vertical [DA_VERTICAL]" Form Preview
Form DA - Implementation Options: Vertical
DA - Implementation Options: Vertical
Was drug accountability collected? No  Yes  
What was the date that drug accountability was assessed?
 01 Jan 2000
What is the treatment label identifier?
What is the drug accountability being assessed? Dispensed Amount  Returned Amount  
What is the amount?
What is the unit?
* Mandatory field