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.
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 Abstract Human Subject Safety Information
- Locate the IRB approval document for a single site on the trial of interest.
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.)
- On the Administrative Data menu, under Regulatory Information, click Human Subject Safety. The Human Subject Safety Information section appears.
Displaying Organization and Person Details
You can display the details of any organization or person, including their CTEP and PO IDs, that appears on abstraction pages by clicking the Details icon (
) located next to an organization or person name field.
- In the Board Approval Status field, select the current state of the trial with respect to Investigational Review Board (IRB) approval. Status definitions are as follows:
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:
- 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.
When you select the Board name, the contact information is displayed automatically in the fields provided.
If you registered a new organization with the CTRO in the previous step, the system will notify you when the record is added so that you may continue your abstraction.
If applicable, complete any of the contact fields that are missing information.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.
