CHLA’s warehouse of patient medical records is a rich source of data for retrospective studies as well as for finding local participants for prospective studies. CHLA researchers (and USC researchers with DHLA appointments) can use CHLA’s i2b2 portal for study planning—feasibility assessments and power analyses—on a self-service basis. I2b2 contains only deidentified patient information, but researchers can request identifiable patient information for screening or recruitment purposes with IRB approval.
How to get access
CHLA researchers are required to complete Human Subjects and HIPAA training. For more information on how to complete the required training, please email email@example.com or refer the CHLA Investigator’s manual. Once complete, and reflecting in your iStar profile, simply email firstname.lastname@example.org requesting access to CHLA i2b2.
Benefits for users
- Sample Size Planning / Feasibility Assessment: Determine how many patients in the USC, CHLA or DHS electronic health records meet your study criteria. View distributions of patients based on gender, race, and age.
- Recruitment or Chart Screening: Use i2b2 to define a set of patients to consider for your study. Then, outside of i2b2, work with the health system(s) to access MRN or contact information. IRB approval is required for identified data sets.
- Outcomes Research: Submit a data request for de-identified data for retrospective analysis
Frequently Asked Questions
The service infrastructure consists of both centralized support staff and embedded staff at CHLA. Embedded staff members are familiar with local practices, policies, and workflows and serve as informatics liaisons between the research community and the clinical operations community.
IRB approval is required whenever a researcher is requesting information beyond aggregate patient counts or outside of *limited data sets. Please explicitly state in your IRB application and or amendment the use of i2b2 and all of the data elements requested. For example, if requesting MRN, phone and medication orders, this must be clearly stated and approved in your IRB application and or amendment. Alternatively, you may run your query in i2b2, submit an i2b2 data request and attach that data request number generated by the system in your IRB application or amendment. For more clarification regarding your specific request, please email email@example.com to set a time to review your scenario.
* A limited dataset is a dataset at the patient level, with all 18 HIPAA identifiers removed or obscured. In this scenario the completion of a Data Use Agreement is required for the release of information.
Clinical Research Informatics
Tooltip: Clinical Trial Management System (CTMS)
USC’s Clinical Trial Management System, OnCore, is a jointly sponsored, web-based software system for managing clinical trials.