Create a CTA or an IND Application

You can create a CTA or an IND Application with the Create Application wizard.

To create a CTA or an IND application from the Create Application wizard:
  1. Click Wizards > Create Application.
  2. In the Create Application page, select the reviewing country:
    Option Description
    CTA application Select the European Union, Canada, and any other country except the United States, Japan, a GCC region country, or South Africa.
    IND application Select the United States or Canada.
    Note: The Procedure Start Date, Procedure End Date, Procedure Identifier fields will appear if you select MRP, CP, DCP or National Procedure Type for any Application type, except CTA and IND.
  3. Enter or select values for the application attributes.
    The attributes will vary, based on the registration type (CTA or IND) selected.
    Upon selecting Clinical Trial Authorization as the registration type, the Application Name field changes to Study Number. 
  4. Next.
  5. In the Create Event page, enter or select values for the event attributes.
  6. Select the values for the Comparator.
  7. Next.
  8. Save.
  9. Choose the applicable procedure to enter an electronic signature for entities:
    Scenario Steps
    When electronic signature is enabled
    1. Select a reason and enter comments for the reason.
    2. Select Save.
    3. Validate your identity by entering your user credentials in the dialog box.