Create a CTA, CTR or an IND Application

Different applications can be created depending on the region using the Create Application wizard.

To create a CTA, CTR or an IND application using the Create Application wizard:

  1. Click Wizards > Create Application.
  2. On the Create Application page, select the reviewing country:
    Option Description

    CTA ap­

    plication

    		 Select the European Union, Canada, WAHO, and any other country except the United States, Japan, a GCC region country, or South Africa.
    CTR application Select Austria, Belgium, Bulgaria, Croatia, Republic of Cyrus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.

    IND ap­

    plication

    		 Select the United States or Canada.

    Note: The Procedure Start Date, Procedure End Date, Procedure Identifier fields will appear when you select a MRP, CP, DCP or National Procedure Type for any Application type, except CTA, CTR and IND.

  3. Enter or select values for the application attributes. The attributes will vary, based on the registration type (CTA, CTR or IND) selected.Upon selecting Clinical Trial Authorization as the registration type, the Application Name field changes to Study Number.
  4. Next.
  5. On 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.