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In your study protocol in Section 5.2, in your own words, state in the Methods and Procedures section that you will be working with the DHS Informatics and Analytics Core to extract the data variables listed, which will be sourced from the DHS Clinical Data Warehouse or DHS i2b2.

Specify that the DHS Investigator(s) will take responsibility for all DHS data management, storage, transfer, and management. PHI files must be only kept within to IRB-approved study personnel with proper DHS credentials, kept within the DHS Intranet, encrypted, password-protected, and behind DHS firewalls. Be sure to enable track changes if making these protocol changes to your IRB.

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Be specific in how DHS PHI will be handled behind County firewalls/DHS Intranet by only IRB-approved DHS study personnel. Provide further details on how the PI will handle DHS data management (i.e. on a password-protected Keck laptop) and if applicable, data transfer (i.e. de-identified data to REDCap)

• Indicate which variables you plan to obtain by working with the Informatics Team and or i2b2.

• Indicate which variables you plan to abstract by conducting further chart review.

• Indicate if you intend to contact DHS patients using the information provided by the Informatics and Analytics core for study recruitment purposes.

In Section 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”

In Section 6.a.1, check the specific DHS facilities that are applicable to your research study. This checkbox triggers the DHS research Oversight Board (ROB) research categorization process. To learn more about this process, click here.

In Section 6a.4, select “Yes” to indicate that this research will potentially benefit DHS patients in the future. Mark the following questions in this section that best reflect your research study.

In Section 42.3, indicate if you plan to contact people whose data will be obtained from the CDW. Ensure that your contact methods and management of DHS PHI are clearly stated in your study protocol in Section 5.2.

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