CTA and IND Application
CTA or an IND Application are the two types of applications.
From the
Create Application wizard, you can create Clinical Trial Authorization (CTA) applications for:
- European Union countries
- Canada
- All other countries except the United States, Japan, Gulf Cooperation Council (GCC) region countries, and South Africa
You can also create Investigational New Drug applications (INDs) for the United States and Canada.
When you create 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. Using the GPP wizard, you can also associate Clinical Trial Shared Data, comparators, PDS, and other entities needed for the project.