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.
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Section 2
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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
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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.  |
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3. In section 13.2.1, please check "Yes" for use of the Clinical Data Warehouse (CDW).
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4. Please Indicate if you intend to contact patients using the information provided by the Informatics and Analytics core for study recruitment purposes.In section 13.3, in your own words, generally state you will be working with the Clinical Research Informatics core to extract the data variables listed in sections 13.2 & 13.3 which will be sourced from the Keck Data Warehouse or Keck i2b2.
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.
5. In section 13.4 Methods and Procedures, please indicate if any identifying patient information is requested.
ADDRESS1
ADDRESS2
Admit Date
City
Discharge Date
Encounter Number
MRN
Name
Phone
State
Zip
6. In section 24.3, indicate if you will or will not require a HIPAA Waiver of Consent.
7. In section 42 indicate which Clinical Data Warehouse you will be requesting data from.
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Section 13
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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. |
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Select ‘Yes’  |
Section 24
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If you will be using the dataset to contact patients for study recruitment, select ‘Clinical Data Warehouse’:  |
Section 35
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Select ‘Yes'  |
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Select ‘Yes’ if you will be requesting to include any of the 18 HIPAA identifiers (listed in Question 35.1) in your dataset. Note that you would only select ‘No’ to this question if you are requesting a fully de-identified dataset.  |
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Please select ‘Yes’ as applicable if your dataset will include HIV data, mental health data, or substance abuse treatment data. Make sure to select ‘Yes’ if your study’s selection criteria has any of this data.  |
Section 36
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Section 42
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Select ‘Keck Medicine of USC’  |
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This can be left blank, as our team will work with you to determine the tool/query that works best for your study.  |
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Select all variables that you will be requesting to include in the dataset. Please note that we cannot include identifiers in your dataset that are not indicated here.
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Select ‘Yes’ if you plan on contacting/recruiting patients using the dataset we provide  |
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Describe how you will contact patients (for example, sending emails to potential subjects)  |
Section 45
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Select “USC HSC - Health Sciences Associated Locations”  |
Section 45a
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Select “Keck Hospital of USC Facilities” and “Keck School of Medicine of USC”  |