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  1. General medications/treatments are defined as any medications/treatments reported by a subject when asked if they have taken any medications in an open-ended way that does not ask about any specific drug. Additional information might be sourced by referring to a subject’s medical record. 
  2. Medications of interest are defined as any medications or classes of drugs specifically mentioned in the protocol and were not the primary focus for determining the CDASHIG Collection Core designations for the domain  (e.g., excluded medications, drugs requiring a washout period prior to dosing in study, rescue medications).domain. 
  3. As with all the data collection variables recommended in the CDASH TIG standard, it is assumed that sponsors applicants will add other data variables as needed to meet protocol-specific and other data collection requirements (e.g., therapeutic area-specific data elements and others as required per protocol, business practice, and operating procedures).
  4. The CMOCCUR field provides a structure for capturing the occurrence of specific medications of interest. Sponsors wishing to capture nonpharmacological therapies (e.g., surgery procedures, aromatherapy, massage, acupuncture) can use the Procedures (PR) domain.