Research Informatics Quick Start Guide

What are the steps involved in obtaining clinical data for research?

Step 1A: Submit an IRB Protocol (if needed)

Decide if your project needs IRB review. Visit the Research Compliance Office's FAQs and Resources page for additional guidance.

If an IRB protocol is needed, submit a request in eProtocol's MyDashboard. Be sure to submit the mandatory Data Privacy Attestation form when requesting a new IRB protocol in eProtocol.

To complete the Data Privacy Attestation form in eProtocol's MyDashboard, start a Modification and follow the link in section 11b or 15 ("Waiver of Authorization" or "Waiver of Authorization for Recruitment") to specify the PHI and roughly categorize the clinical data in your data request. For a Chart Review protocol, follow the link in section 3a or 5 ("Waiver of HIPAA Authorization").

Once you have created the Data Privacy Attestation, open the protocol in "Edit" mode and click the link in section 11b/15 or 3a/5 to import the attestation into the protocol. The tool will generate text in section 11b/3a. Be sure to click the "Save" icon.

When the IRB approves your protocol, you will receive an e-mail notification. The IRB's panel meeting dates and deadlines are available here.

Step 1B: Complete a mandatory Data Privacy Attestation

For clinical operations or Quality Improvement projects, follow these instructions to fill out a Data Privacy Attestation outside of the  eProtocol system.

Step 2: Obtain Data Privacy Attestation approval

When you complete the attestation form we are electronically notified. Stanford Health Care and Stanford Children's Health require that requests for clinical data for research be verified by a third party; this verification process involves checking that either the data requested is fully de-identified (if covered by a determination) or the language used in the request is consistent with the language in the IRB, and also that that IRB is internally consistent (if covered by an IRB).

If any discrepancies are found you will be asked to revise either the wording of the request or of the IRB in order to bring them into accordance with each other.

Step 3: Obtain data from the Research Informatics Center

Once we have approval to proceed with releasing the data we will work with you to verify that the data we supply meets your research needs. 

When does RIC require IRB involvement?

If you are doing research, you must involve the IRB. No exceptions. Even if you only need counts from the cohort tool, you must go to the IRB and get a determination of non-human-subjects review prior to publication of results.

That being said, both the cohort tool and the chart review tool are available to researchers who have not yet launched their investigation. This is known formally as "support for preparatory to research activities," and we are delighted to be able to offer aggregate counts and descriptive statistics, either via the cohort tool or via custom queries to the clinical data warehouse, as well as anonymized data review cohorts, in support of this important early phase to research projects. However, this data can only be used to prepare for the formal launch of your research study (e.g. applying for funding).

What are my options for obtaining data?

There are two basic modes for obtaining clinical data for research, chart review and data extraction. In chart review, we provide you with the URL to an online portal to the data suitable for manual review. In data extraction we supply you with a data set in the format of your choice, typically comma separated value text file suitable for loading into a statistical analysis tool such as SAS or R. Your choice of which option to pursue will typically be dictated by how the information you seek is represented: information in narrative form (e.g. in clinic notes and reports), is not generally amenable to data extraction and must be reviewed manually. If, however, you are interested in structured data such as lab values, billing codes, flow sheet data, etc., we can create a data extract for you.

The language in the confidentiality/privacy and HIPAA authorizations sections of your IRB must accord with the language generated by the Data Privacy and Security attestation forms. If there is a disconnect, you will be asked to revise either your request or your IRB in order to bring them into agreement.

What if I need data for non-research purposes?

If you need data in support of clinic operations or quality improvement, you should request assistance from the appropriate hospital reporting group. Our group can only give out data in support of research.

How do I get help analyzing the data?

The process for obtaining the services of a biostatistician varies by department. Check first within your department to see whether there is an analyst on staff who can assist you. If not, you should make a point of familiarizing yourself with the services offered by the Stanford Center for Clinical and Translational Education and Research, or SPECTRUM. They act as a clearinghouse for research support at the Stanford School of Medicine. They will refer you back to Research IT for informatics services, but will be able to connect you to sister service organizations such as biostatistical services and study design.

I still have questions!

Contact us! We're here to help. Please fill out a consultation request to let us know how we can assist you.