Add Additional IRB/ECs

Although clinical trial organizations today adhere to protocols from a central IRB/EC, at times, it might be required to adhere to protocols of more than one IRB/EC. For example, an organization may have one central IRB/EC and one or more local IRB/ECs.

In the Site profile, you will be able to specify only one IRB/EC of any type. In case you need to provide additional IRB/ECs, proceed with the steps below:

  1. From the Grid Pane, double-click the site for which you want to specify additional IRB/ECs
  2. The Site Details window opens.
  3. Click the IRB/EC tab from the left pane. This opens the IRB/EC page.
  4. The top menu bar displays two options – Add Existing and Create.
  5. If clicked ‘Add Existing’ – an Add Existing IRB/EC popup window opens. Select the required checkbox(s) and click the Add IRB/EC button displayed at the bottom of the popup window.

  6. If clicked ‘Create’ – a Create IRB/EC window opens. Enter the details in all the fields marked with an asterisk and the other details if required. The fields marked with an asterisk:
    • IRB/EC Name
    • IRB/EC Type
    • Address
    • City
    • State
    • Country
  7. Click the Create IRB/EC button displayed at the bottom of the popup window.
  8. If the user wants to create another IRB/EC at the same time, click Save and Create Another button.

  9. The procedure to add from existing IRB/ECs is also the same, with the only difference being that from within the site, the Add Existing functionality will only display the IRB/ECs available in the data room.