The information you are required to provide depends on the Board approval status and other indicators, as noted in the instructions that follow. Human subject safety information is optional for Abbreviated trials.Â
The only field that you are required to complete in this section is the Board Approval Status. Other fields are either optional or non-editable. The latter are indicated by gray fields.
Some fields in this section are optional, and some may be required only when you have selected certain attributes in preceding fields. For example, if the Board Approval Status is "Submitted, exempt", the Board Name, Board Affiliation, and Board Contact fields are mandatory, but the Board Approval Number is optional.
The following table provides a matrix of field requirement dependencies.
Matrix of field requirements
Board Approval Status | Board Approval Number | Board Name | Board Affiliation | Board Contact |
|---|---|---|---|---|
Submitted, approved | Mandatory | Mandatory | Mandatory | Mandatory |
Submitted, exempt | Optional | Mandatory | Mandatory | Mandatory |
Submission not required | Optional | Optional | Optional | Optional |
How to complete the Institutional Review Board (IRB) section
The Board Approval Status must correlate with the current Trial Status as follows:
- If the current Trial Status is In Review, the Board Approval Status must be Submitted, Pending.
- If the current Trial Status is Withdrawn, the Board Approval Status must be Submitted, Denied.
For other rules regarding Board Approval Status, see Trial Completion Criteria.
In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field for Complete trials.
Field Label | Description/Instructions |
|---|---|
Board Approval Number* | If the trial has been submitted and approved, type the number assigned to the protocol by the human subjects review board in the field. If the number does not appear in the IRB approval document, enter the date. |
Board Name* | Click Look Up to search for and select the Board name. If the name is not listed, register it with the CTRO. See Searching for Organizations. |
Board Affiliation | If the status is other than Submission Not Required, enter the name of the affiliated organization. |
To save the details you have abstracted, click Save.
