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:
-
Click
.
-
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.
-
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.
-
Next.
-
In the
Create Event page, enter or select values for the event attributes.
-
Select the values for the
Comparator.
-
Next.
-
Save.
-
Choose the applicable procedure to enter an electronic signature for entities:
| Scenario
|
Steps
|
| When electronic signature is enabled
|
- Select a reason and enter comments for the reason.
- Select Save.
- Validate your identity by entering your user credentials in the dialog box.
|