CIS data mappings for specialized Clintrial panels

Context

Contains context items, which are included in every record in a clinical data table. The context items form the primary key of the clinical data record.

• If selected—Custom context panel made up of the items that are mapped to the data series in the data set.
• If not selected (default)—Default context panel created during deployment.

  For more information, see MedML definition of the default context panel.

Note: A data mapping can have only one data set with a Context panel type.

Enrollment

Contains screening and enrollment data for each study subject. The Clintrial application does not use separate records for screening and enrollment data.

• If selected—Custom enrollment panel made up of the items that are mapped to the data series in the data set. The data mappings for the custom enrollment panel exist only in the data mapping where the data set is defined.
• If not selected (default)—Enrollment panel made up of:
  • The items in the combined screening and enrollment forms in the study design, if they exist.
  • The items in the combined default screening and enrollment forms generated by the Central Designer application, if the forms are not defined in the study design.

    The data mappings for either version of the default enrollment panel are included in the mappings for all data mappings for a study.

Non-Patient Data

Contains data that is not related to a particular subject or visit, such as standard coding thesauruses, view codelists, or laboratory normal ranges.

If selected, the Central Designer application generates data mappings for a non-patient data panel that has a column for each data series in the data set.

Note: The data series in a non-patient data set must not have any items mapped to them.