Create a CTA or an IND Application from the Product Family Attributes Page

From the Product Family Attributes page, you can create Clinical Trial Authorization applications (CTAs) for:

European Union countries
Canada
All other countries except the United States, Japan, Gulf Cooperation Council (GCC) region countries, and South Africa

From the Product Family Attributes page, you can also create Investigational New Drug applications (INDs) for the United States and Canada.

Consider the following when creating a CTA or IND application:

To track CTA data on the application, the application type selected must be mapped to the Clinical Trial Application Entity XML Type xml in Data Administration. By default, the application type Clinical Trial Authorization is already mapped to this xml type.
To track IND data on the application, the application type selected must be mapped to the Investigational New Drug Entity XML Type in Data Administration. By default, the application type Investigational New Drug is already mapped to this xml type.
In addition to using this procedure, you can also create a CTA or an IND application using the Create Application wizard or the GPP wizard. When you use the Create Application wizard, you also create an event. By using the GPP wizard, you can also associate Clinical Trial Shared Data, comparators, PDSs and other entities needed for the project.

To create a CTA or an IND application from the Product Family Attributes page:

Navigate to the Product Families tabbed page.
Click a link for the product family.
The Product Family page appears.
In the Product Family page, on the Application tab, click Create.
The Create Application page appears.
In the Create Application page, select the reviewing country:
- For a CTA, select the European Union, Canada, and any other country except the United States, Japan, a GCC region country, or South Africa.
- For an IND application, select the United States or Canada.
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.
Save.

Choose the applicable procedure to enter an electronic signature for entities:


Scenario	Steps
When electronic signature and SSO are enabled	Select a reason and enter comments for the reason. Select Save. Validate your identity by entering your user credentials in the dialog box.
When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Save.