Adding or Creating New IRB/ECs
To add IRB/ECs as required by sites, the administrator needs to do the following:
- Assuming that you are in the room Settings section, click IRB/EC from the left panel.
- The IRB/EC Management window opens in the right side panel. Refer to the screenshot
below.
- Click Add in the top menu bar from the IRB/EC Management window.
- This opens a blank IRB/EC Profile form to fill in the data. Enter all the
details as applicable. Note that the fields maked with red asterisk (*) are
required. Refer to the screenshot below.
- Approval Cycle: This is the IRB/EC’s processing time and can be denoted in days/weeks/months.
- Buffer Time: This is the extra time IRB/EC may need to approve the documents.
- Meeting Frequency: This denotes the meeting frequency of
the IRB/EC which could be daily/weekly/monthly/yearly.
- Click the Select button to open the Meeting Frequency popup window. Select a required radio button for Frequency and the required appropriate option(s) from the right pane related to the Frequency.
- Select the Start and End Date from the
calendar
icon for Range of Recurrence section. Click OK to
save the changes. Refer to the screenshot below.
Note: The right pane is dynamic as per the option selected in the Frequency section. - Submission Deadline: This denotes the submission deadline in day/week/month/year before theIRB Meeting Date.
- Click the Committee tab in the popup. This allows you to add the
details of Ethics Committee associated with the IRB. Refer to the screenshot
below.
- Click Add in the Committee tab. This will add a new row to add an ethics committee by the name of ‘New Committee’.
- Double-click each field in the row to enter the details for the committee.
- Click Ok.
- This opens a blank IRB/EC Profile form to fill in the data. Enter all the
details as applicable. Note that the fields maked with red asterisk (*) are
required. Refer to the screenshot below.
- This will add the IRB/EC to the study and also to the centralized IRB library.
- Repeat the process for as many IRB/ECs as required.