IRB Instructions for Keck Data Requests

Please include the following information on your new IRB application. If you are filing an amendment to an existing IRB application, please use this as a guide for the information you need to include.

Section 2

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’

Section 9

If your study involves secondary analysis (ex. retrospective chart review), select the secondary analysis option that applies to your research. Checking one of these boxes triggers the activation of section 13, also needed for your application.

Studies conducting retrospective review of medical records typically select the second checkbox: “Secondary Analysis. Thus study involves use of data/specimens that have been or will be collected/generated for non-research purposes (e.g., medical records, student records).”

Section 13

If you would like to include patients known to be deceased in the dataset, please select ‘Yes’. Otherwise, we will automatically exclude any patient known to be deceased from your dataset.

Note that patients are typically only marked as known to be deceased in the medical record if they pass away while admitted to the hospital.

Select ‘Yes’

Section 24

If you will be using the dataset to contact patients for study recruitment, select ‘Clinical Data Warehouse’:

Clinical Research Informatics FAQs

IRB Instructions for Keck Data Requests

Analytics

Please include the following information on your new IRB application. If you are filing an amendment to an existing IRB application, please use this as a guide for the information you need to include.

Section 2

Section 9

Section 13

Section 24

Section 35

Section 36

Section 42

Section 45

Section 45a

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