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changes.mady.by.user Darcy Wold

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changes.mady.by.user Alana St. Clair

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  1. Definition: The Clinical Observations (CL) domain captures clinical sign information in addition to ophthalmology, physical examination, and dermal examination collected during the in-life phase of the study.
  2. Categorization: CLSCAT, CLTESTCD, and CLTEST can be used by the sponsor applicant to categorize data that were collected during in-life observation. CLCAT is fixed to the values specified in CDISC Controlled Terminology CLCAT list.
  3. Results definition:
    1. CLORRES contains the complete description of the clinical observation.
    2. CLSTRESC should contain only the finding without modifiers. At this time it is not necessary to submit the additional modifiers elsewhere in this domain.
    3. CLRESCAT is used for post-collection categorization of results and should not be a duplication of CLTEST or CLSCAT, which are considered categories at the time of collection.
  4. The CLSPID variable is intended to reflect the identifier for any observed masses. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (CL, Palpable Masses, Macroscopic Findings, and Microscopic Findings, and Tumor Findings).
  5. Timing variables:
    1. Information about the time of collection for any observation is needed to identify the record. CLDTC is expected, and the data will, in most cases, contain CLDTC, CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; in those cases, CLNOMDY must be populated.
    2. CLTPT, CLTPTNUM, and CLELTM can be used when observations are made based on an elapsed time from a reference time point (e.g., 1 hour post-dose).