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  1. This domain contains details regarding the collection of PK samples from subjects (e.g., timing of sample collection, associated specimen properties) at the investigational site. Typically, the CDASHIG PC domain collection does not include concentration results generated by a bioanalytical laboratory. However, if the sponsor applicant has occasion to collect concentration results on the same CRF, variables may be created based on CDASH Model variables, using the rules previously discussed.
  2. Other data (e.g., demographics, vital signs, substance use, exposure) may be needed for PK analysis. See the CDASHIG TIG collection sections for these related domains.