CDW 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

Question 2.1

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 6

Question 6.1

Select ‘USC HSC - Health Sciences Associated Locations’

Section 6a

Question 6a.1

Select ‘Keck Hospital of USC Facilities’ and ‘Keck School of Medicine of USC’

Section 9

Question 9.1

Select one of the secondary analysis options, that most apply to your research. Checking one of these boxes triggers the activation of section 13, also needed for your application.

Section 13

Question 13.1

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.

Question 13.2

Upload a Data Collection Form which includes all of the variables you will need for the research. Please differentiate between data elements you plan to abstract from the chart and data that will be obtained using the CDW Team and or tools such as i2b2.

Question 13.2.1

Select ‘Yes’

Question 13.3

In your own words, generally state you will be working with the Clinical Research Informatics team to extract data variables from the Keck Clinical Data Warehouse

Indicate which variables you plan to obtain by working with our team.
If applicable, indicate which variables you plan to abstract by conducting your own manual chart review.
If applicable, indicate that you plan on contacting/recruiting patients using the data obtained from our team.

Section 24

Question 24.1 (for studies recruiting subjects only)

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

Section 35

Question 35.1

Select ‘Yes'

Question 35.2

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.

Questions 35.3 to 35.6

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

Question 36.1

If you will be using the dataset to contact and recruit subjects for your study, select ‘Partial Waiver of HIPAA Authorization for screening, recruiting, and identifying participants’
Otherwise, select ‘None of the Above’

Section 42

Question 42.1

Select ‘Keck Medicine of USC’

Question 42.1.2

This can be left blank, as our team will work with you to determine the tool/query that works best for your study.

Question 42.2

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.

A commonly missed item is dates. If you are requesting to include any dates in your dataset (date of birth, admission date, etc), make sure to select ‘All elements (except years) of dates related to an individual’

Question 42.3

Select ‘Yes’ if you plan on contacting/recruiting patients using the dataset we provide

Question 42.3.1

Describe how you will contact patients (for example, sending emails to potential subjects)