DHS IRB Instructions for iStar

Ensure that all study personnel that will access the data are listed. If they will access identifying patient data (names, dates, MRNs, etc.), select ‘Yes’ under ‘Access Identifiable Data’.

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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.

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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 Question 9.1 Methods and Procedures, check one of the “Secondary Analysis” options that is most relevant to your research. Checking one of these boxes triggers the activation of Section 13.

In Question 13.1, indicate “Yes” or “No” if you will be including DHS patients who are deceased. This must also be indicated in your patient cohort inclusion/exclusion criteria.

In Question 13.2, upload a Data Collection Form which includes all of the variables you will need for the research data request (can be a Word Doc or Excel Sheet).

Please differentiate between data elements you plan to abstract from the chart and data that will be obtained using the Informatics Core team and or tools such as i2b2. If applicable, please also include a PDF of your i2b2 print query report. Please review the how-to "Print Query" article for further instruction.