Calyx RIM for Registrations

Associate or Disassociate Clinical Trial Shared Data

You can associate Clinical Trial shared data with an event based on the type of associated application and the status of the event.

Consider the following regarding Clinical Trial shared data:
  • You can associate Clinical Trial shared data only with a new or existing event that is associated with a CTA or IND application.
  • You can associate one or more Clinical Trial shared data entities with an event that is associated with an IND application.
  • You can associate only one Clinical Trial shared data entity with an event that is associated with a CTA application.
  • You can associate the same Clinical Trial shared data with more than one event.
  • You cannot associate Clinical Trial shared data with a closed event.
  • You cannot disassociate Clinical Trial shared data from a closed event.
  • You cannot associate Clinical Trial shared data with an event that is associated with a project.
  • You cannot disassociate Clinical Trial shared data from an event that is associated with a project.
To associate or disassociate Clinical Trial shared data when you create an event:
  1. On the Create Event page, in the CT Shared Data list, do one of the following:
    • To associate Clinical Trial shared data, in the Available box, select one or more protocol numbers, and click the button with the two right angle brackets. The Selected box now contains the protocol numbers.
    • To disassociate Clinical Trial shared data, in the Selected box, select one or more protocol numbers, and click the button with the two left angle brackets. The Available box now contains the protocol numbers.
  2. Save.
  3. Choose the applicable procedure to enter an electronic signature for entities:
    Scenario Steps
    When electronic signature and SSO are enabled
    1. Select a reason and enter comments for the reason.
    2. Select Save.
    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 Save.