Clinical Data Compliance Quick Start

Access to Stanford clinical data for research requires both Research Compliance Office (IRB) and University Privacy Office approval.

On This Page

  • Quick Start Guide
  • Frequently Asked Questions

Quick Start Guide

Visit the Research Compliance Office's FAQs and Resources page to determine if your project needs IRB review. If the RCO determines that an IRB protocol is needed for your project, submit the request in eProtocol's MyDashboard.

Be sure to submit a Data Privacy Attestation 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 to roughly categorize the clinical data being requested. 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 email notification. The IRB's panel meeting dates and deadlines are available here.

Frequently Asked Questions

If you are doing research, you must involve the IRB. No exceptions. Even if you only need counts from the STARR Cohort Discovery Tool, you must get a determination of non-human-subjects review from the IRB 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).