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.
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 | N/A | Mandatory | Mandatory | Mandatory |
Submitted, pending | N/A | Mandatory | Mandatory | Mandatory |
Submitted, denied | N/A | Mandatory | Mandatory | Mandatory |
How to Abstract Human Subject Safety Information
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
Submitted, Approved - IRB approval has been requested and obtained
Submitted, Exempt - IRB has granted an exemption in response to the approval request
Submission Not Required - Study does not require human subjects review
Submitted, Pending - Study is pending IRB review
Submitted, Denied - IRB has denied approval for the study
If you selected anything other than Submission Not Required, continue with the next fields. Otherwise you are finished with human subject safety abstraction.
The Board Approval Status must correlate with the current Trial Status as follows:
|
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, abstract the IRB approval date from the IRB document in the following format: mm/dd/yyyy. The IRB approval date may be labeled as Action Date or Approval Date. |
Board Affiliation* | Click Look Up to search for and select the Board affiliation. If the name is not listed, register it with the CTRO. See Searching for Organizations. |
Board Name | 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.