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1. Locate the IRB approval document for a single site on the trial of interest.

2. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

3. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

4. 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.)

5. On the Administrative Data menu, under Regulatory Information, click Human Subject Safety. The Human Subject Safety Information section appears.
   

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   Display Organization and Person Details - Include v4.4 Display Organization and Person Details - Include v4.4

   
   
6. 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

7. If you selected anything other than Submission Not Required, continue with the next fields. Otherwise you are finished with human subject safety abstraction.

   Note
   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 If the current Trial Status is Withdrawn, the Board Approval Status must be Submitted, Denied.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.

8. To save the details you have abstracted, click Save.