Retrospective Review

Chart Review or Future Dataset Applications

For studies that use existing medical records or datasets to answer research questions, without direct patient contact or intervention.

Review TypeExpedited
Study TypeRetrospective / Prospective
Required FormsA through F

Ready to Submit?

Complete forms A through F. Submit through the portal. Follow the expedited pathway.

Chart review submissions follow the expedited review track. Complete packets move faster than incomplete ones.

Start Submission

  • Study uses existing or future records only
  • No direct patient contact
  • All investigators CITI-certified
  • HIPAA authorization waiver justified
  • Data security plan documented

Is Your Study Eligible?

Chart review studies use existing or future health information to answer research questions.

  • Uses existing records only or will beData has already been collected as part of routine clinical care.

  • No direct patient contactYou won't be interacting with patients as part of the research.

  • No intervention or treatmentThe study doesn't change how patients are cared for.

Not sure if this is right?

Take our 2-minute pathway quiz to find the right review type based on your study design.

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Talk to a coordinator

For complex studies, a 15-minute consult can save weeks of back-and-forth.

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Required Forms

All forms can be completed online through the IRB portal or downloaded as fillable PDFs.

A
Application Form

Study overview, investigator information, and basic details.

Required
B
Protocol Document

Detailed research plan, methodology, and data analysis approach.

Required
C
HIPAA Authorization Waiver

Justification for accessing PHI without individual authorization.

Required
D
Data Security Plan

How data will be stored, accessed, and protected throughout the study.

Required
E
Investigator CV & Training

Current CV and CITI training certificates for all study personnel.

Required
F
Conflict of Interest Disclosure

Financial and other potential conflicts for all study personnel.

If applicable
Dataset Application

Additional form required when requesting access to enterprise datasets.

If applicable

Submission Process

Chart review studies follow the expedited review pathway. Here's what to expect.

1
Prepare your packet

Complete forms A through F and attach the dataset application if you'll need enterprise data access.

2
Submit through the portal

Upload all documents at once. Incomplete submissions delay review.

3
Pre-review screening

The IRB coordinator confirms completeness and assigns an expedited reviewer. This step may require additional documents or revisions.

4
Reviewer evaluation

The assigned reviewer evaluates the submission on the expedited track. You may receive requests for clarification or revisions.

5
Determination letter

You'll receive approval, conditional approval, or a request for revisions.

Chart Review FAQs

Do I need patient consent for a chart review?
Not typically. Chart reviews use existing records and qualify for a HIPAA authorization waiver under specific conditions: minimal risk, the research couldn't practicably be done without the waiver, and adequate data protections are in place. Form C documents this waiver.
Can I include data from other institutions?
Yes, but you'll need a Data Use Agreement (DUA) in place. Multi-site studies may also require reliance agreements. Contact the IRB office early if this applies.
How long does approval typically take?
Complete submissions move quickly through the expedited pathway. Submissions with missing documents or requiring revisions take longer. Contact the IRB office for current timeline expectations.
What if my study evolves into prospective data collection?
You'll need to submit an amendment and potentially move to a different review pathway. Contact the IRB before making changes to your data collection approach.
Do I need annual continuing review for a chart review?
Most expedited chart reviews don't require continuing review under the revised Common Rule, but you'll need to submit a closure report when the study is complete and report any significant changes via amendment.