Clinical Data Compliance Quick Start

For clinical operations or quality improvement projects read these instructions and fill out a Data Privacy Attestation outside of the eProtocol system after clicking on the "New" button in the top menu of the DPA landing page.

We will be electronically notified after you complete the attestation form. 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 the language in the attestation is consistent with the language in the protocol and that that protocol is internally consistent (if the data requested is identifiable).

If any discrepancies are found you will be asked to revise either the wording of the attestation or the wording of the protocol so both are in compliance.

Once the necessary Research Compliance Office (IRB) and required University Privacy Office approvals are in place, we will work with you to verify that the data we supply meets your research needs.

Please submit a request through our intake form if starting a new project with RIC. Keep in mind that only one hour of consultation is offered free of charge.

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, data is shared using the comma-separated values (.csv) file format suitable for use in a statistical analysis tool such as SAS or R.

The choice of which option to pursue will typically be dictated by how the information you seek is represented. Information in narrative form (e.g., clinical 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, or flow sheet data 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.

Data for research obtained from RIC is subject to compliance agreements implemented by Stanford Health Care (SHC) or Stanford Children’s Health (SCH). Such agreements change over time and may result in the filtering of the patient and/or encounter records. This means that a data record obtained on one date may be filtered out at a later date, even for the same query.

If you need data in support of clinic operations or quality improvement, you should request assistance from the appropriate hospital reporting group. Our group only grants access to data in support of academic research.

First, check with your department to see if there is a biostatistician on staff available to assist you. If none are available, you should familiarize yourself with the services offered by the Stanford Center for Clinical and Translational Education and Research (SPECTRUM). Spectrum acts as a clearinghouse for research support at the Stanford School of Medicine and maintains a list of services available to researchers. You may also request a statistical consultation directly.

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