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Description/Overview

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Concomitant Medications (CM) is an Interventions domain used for concomitant and prior medications/products used by the subject, such as those given on an as needed basis or condition-appropriate medications. The same basic data collection variables should be collected for all medications, treatments, products and therapies (prior, general concomitant medications, and medications of interest). If additional fields are needed to collect other data about a medication of interest, those should be added as nonstandard fields.

Note:

• Applicants may use terms like concomitant medications, treatments, products or therapies, as appropriate for the study. The following text may use one of these terms, but applicants can always use the term most appropriate for their study.
• The term prior refers to medications/treatments/products that were started before study participation, because limited information may be available on prior interventions taken by a subject; the core requirements were constrained to reflect this limitation.
• Applicants should define the appropriate collection period for prior and concomitant medications/treatments/products in the study protocol.

Specification

Assumptions