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Creating a regulatory document form

You can create only one regulatory document form in a study. You can create multiple forms in a library. When you create a regulatory document or visit report form in the NonClinical container, the Special Forms custom property in the Properties Browser is automatically set to the appropriate value (either Reg Docs or Visit Report).

A regulatory document form is not repeating by default, but you can mark it as repeating.

  1. In the Project Explorer, select the Forms and Transactions Explorer bar.
  2. Select the Non-Clinical folder.
  3. In the workspace, click New > Reg Docs Form.

    The Object Name dialog box appears.

  4. In the Title field, type the title of the study object.

    As you type, the RefName field is filled in, using the Title text but omitting spaces and disallowed characters.

  5. Optionally, in the RefName field, type a different RefName from the default.
  6. Optionally, in the Description field, type a description of the study object.
  7. Click OK.

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