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  1. This domain contains It is up to the applicant to determine which data collection scenario best meets the study needs.Typically, only details regarding the collection of PK samples from subjects (e.g., timing of sample collection, associated specimen properties) are collected at the investigational site. Typically, collection does not include concentration results generated by a bioanalytical laboratory.
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    keyTOBA-175
    However, if Analyte test results are provided directly to the applicant from the bioanalytical laboratory and not on a CRF. The applicant would directly populate the analyte results when creating the SDTM-based datasets. 
  2. If the applicant has occasion to collect concentration results on the same CRF, variables may be created based on CDASH Model variables, using the rules previously discussedthe analyte test results on a CRF, the test would be the analyte name. It is recommended that the test names be pre-printed on the CRF rather than collected in a free-text field.
  3. Other data (e.g., demographics, vital signs, substance use, exposure) may be needed for PK analysis. See the TIG collection sections for these related domains.