Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  1. Using the root variables and other CDASH metadata in the CDASH Model, add any additional variables that are needed to meet the requirements of data collection.

    1. Refer to both the CDASH Model and Appendix x, CDASH Model Metadata Tables.
    2. Follow CDASH root variable-naming conventions where they exist (e.g., --DAT for dates, --TIM for times, --YN for prompts, as described in the CDASH Model) and align with Appendix x, CDISC Variable-naming Fragments, conventions as applicable.

  2. Select variables from the SDTM when variables fields from the CDASH Model cannot be used. Selection of variables must align with SDTM Usage Restrictions.
  3. Create a new data collection field when fields in the CDASH Model and variables from the SDTM cannot be used.

    1. When creating a new data collection field, determine whether the data will be used for an operational use case, such as data cleaning, or are actual data to be represented in a tabulation dataset. In general, new data collection fields (not already defined in the CDASH Model) will fall in one of following categories:

      1. A field used for operational, Data Cleaning purposes only.

      2. A field used to collect data that have Direct Mapping to a target variable in the tabulation dataset.

      3. A field used to collect data that have No Direct Mapping to a target variable in the tabulation dataset.

    2. The table below provides implementation guidance aligned with both the category of the field and target variable.

...