Data relating to concomitant and prior medications used by the subject, such as those given on an as-needed basis or condition-appropriate medications are collected. Thesame basic data collection variables should be collected for all medications, treatments, and therapies (prior, general concomitant medications, and medications of interest). Reacreational substances are not represented in this domain. However, medical proudcts recognized to reduce nicotine dependence would be represented in this domain (e.g., Nicotine replacemnet patches).
Example
This is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.
The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.
Rows 1-4:
The subject reported each instance of aspirin use. The frequency of each instance is represented in CMDOSFRQ and is ONCE.
Rows 6-8:
The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a nasal spray where 2 sprays were taken twice a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft.
Row 9:
The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating the product in this study.