Clinical Investigations

The Clinical Investigations tab lists the systematic investigation that is applied for human beings to assess the safety and performance of the clinical devices.

Required Access Roles:

  • App-specific: Product Manager
  • Baseline: Leader

To access this page:

  • Open the required ASPI. For more information, see Opening a Product Identification.
  • In the navigation pane, click Content.
  • From the page, click the Clinical Investigations tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Name The name of the clinical investigation (CI).
State The lifecycle of the CI.
Title The title of the CI.
Clinical Investigation ID The unique identity number of the CI.
Owner The preson who is responsible for the CI.

Actions and Toolbar Commands

Action Description
Edit Lets you edit the details of the selected clinical investigations. You can edit a clinical investigation in the In Work state.
Delete Deletes the selected clinical investigation. You can delete a clinical investigation in the In Work state. You also cannot delete the selected clinical investigation if it is created from the earlier revision.
Insert new row Lets you insert the rows above or below of the selected row.
Note: This option is enabled in the Edit mode. When you enter the row, add the details in the related columns and the CI is created with the added details. For more information, see Creating a Clinical Investigation.
Remove inserted row(s) Lets you remove the inserted rows.