Calyx RIM for Registrations

Create a New Clinical Trial Project

To create a new clinical trial project:
  1. Click Wizards > Global Project Plan.
    The Project Details page appears.
  2. For the Project Type attribute, select Clinical Trial or a type that maps to the internal project type of Clinical Trial, defined in Data Administration.
  3. Enter or select values for the project attributes.
  4. Click Next.
    The Define Project Flow page appears.
  5. Select the flow option for the project.
    • If you select Create New CTA and/or IND Application(s) or Create New CTA and Create New Event for Existing IND Application(s), the Select Products and Countries page appears.
    • If you select Create New Event for Existing CTA and/or IND Application(s), the Select Filter Criteria page appears.
  6. Click Next.
  7. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature and SSO are enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
    When electronic signature is enabled and SSO is disabled
    1. Select a reason and enter comments for the reason.
    2. Enter user ID and password and click Next.
  8. Create a new CTA and/or IND Application, a new CTA and New Event for an existing IND, or a new Event for an Existing CTA and/or IND Application.