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Creating a Regulatory Document Checklist

To create a Regulatory Document Checklist:

  1. Using the appropriate MedML components, define a form that captures the data you want to include in the Regulatory Document Checklist.
  2. In the form definition, specify REGDOC as the value of the TYPE attribute.
  3. Include the form in a visit definition that has the following characteristics:
    • The value of the visit TYPE attribute is MONITOR.
    • The value of the UNSCHEDULED attribute is True.

Note: These instructions describe how to set up a Regulatory Document Checklist that is not repeating. To create a repeating Regulatory Document Checklist, follow the instructions for creating a Visit Report, substituting REGDOC as the value of the Form TYPE attribute.

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