Institutions or 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 as below:

1. From the Grid Pane, double-click the site for which you want to specify additional IRB/ECs.
2. The Site Profile window is displayed.
3. Click the Institutions tab displayed at the top of the screen.
4. Click the Add button from the top menu bar.
5. The rest of the procedure is the same as specified in sections Adding or Creating New IRB/ECs and Adding Existing IRB/ECs to Data Rooms.
6. The procedure to add from existing IRB/ECs is also the same, with the only difference that from within a site, the Add Existing functionality will only display the IRB/ECs available in the data room.