Page Comparison

In your study protocol in Question 5.2, in your own words, state in the Methods and Procedures section (using track edit changes) 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.

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.