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changes.mady.by.user Christine Connolly

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  1. The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis. Events typically include what the event was, captured in --TERM (the topic variable), and when it happened (captured in its start and/or end dates). The intent of the domain model is to capture protocol deviations that occurred during the course of the study (see ICH E3, Section 10.2[1]; https://database.ich.org/sites/default/files/E3_Guideline.pdf).
  2. This domain should not be used to collect entry-criteria information. Violated inclusion/exclusion criteria are stored in IE. The Deviations DV domain is for more general deviation data. A protocol may indicate that violating an inclusion/exclusion criterion during the course of the study (after first exposure) is a protocol violation. In this case, this information would go into DV.
  3. Any identifier variables, timing variables, or Events general observation-class qualifiers may be added to the DV domain, but the following qualifiers would generally not be used: --PRESP, --OCCUR, --STAT, --REASND, --BODSYS, --LOC, --SEV, --SER, --ACN, ‑‑ACNOTH, --REL, --RELNST, --PATT, --OUT, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE, --CONTRT, --TOXGR.