CTA, CTR and IND Application

CTA, CTR, and IND application types are used to obtain authorization to conduct a clinical trial in a specific country.

Using the Create Application wizard, you can create applications for different regions:


Application Type	Countries
Clinical Trial Authorization (CTA)	European Union Countries Canada Other countries except United States, Japan, Gulf Cooperation Council (GCC) region countries, and South Africa
Investigational New Drug applications (INDs)	United States and Canada
EU Clinical Trial Regulation (CTR)	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

The CTA, СTR, and IND applications are used for tracking specific data required by the regulatory authorities:

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 CTR data on the application, the application type selected must be mapped to the Clinical Trial Regulation Entity XML Type XML in Data Administration. By default, the application type Clinical Trial Regulation 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.
You can create a CTA, CTR or an IND application using the Create Application wizard or the GPP wizard.