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changes.mady.by.user Christine Connolly

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  1. General medications/treatments/products are defined as any medications/treatments/products reported by a subject when asked if they have taken any medications in an open-ended way that does not ask about any specific drugintervention. 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 interventions specifically mentioned in the protocol and were not the primary focus for determining the Collection Core designations for the domain. 
  3. As with all the data collection variables recommended in the TIG standard, it is assumed that applicants will add other data variables as needed to meet protocol-specific and other data collection requirements.
  4. The CMOCCUR field provides a structure for capturing the occurrence of specific medications interventions of interest.