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. However, the iStar fields possibly will not match.
1. In section 9. Methods and Procedures, please check 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.
2. In section 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. If applicable, please also include a PDF of your i2b2 print query report. Please review the how-to "Print Query" article for further instruction
3. In section 13.2.1, please check "Yes" for use of the Clinical Data Warehouse (CDW).
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.
9. In section 42.2, please indicate which variables from the CDW you will require. Please the variables you choose aligns with other sections of your IRB protocol. For example, in other sections, researchers often indicate they will not store PHI and then request an MRN list in section 42.
10. In section 42.3 please indicate if you plan to contact people whose data will be obtained from the CDW.
