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The level of evidence for a retrospective cohort is 2.
Table 1 Level of EvidenceQualifying StudiesIIIRetrospective comparative study; case-control study; or systematic review of these studiesIVCase-seriesVExpert opinion; case report or clinical example; or evidence based on physiology, bench research, or first principles2 more rows
A waiver of informed consent is requested because this is a minimal risk retrospective chart review in which no patient interaction will occur. Obtaining informed consent will require contacting each patient directly, increasing the risks to patient privacy.
Retrospective Chart Review- evaluates patient data that is existing at the time the protocol is submitted to the IRB for initial approval. This type of chart review uses information that has usually been collected for reasons other than research.
Primary data collection either by a retrospective medical chart review, as part of a prospective observational study or use of retrospective claims data, are common methods in non-interventional health care research.
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A Retrospective Chart Review evaluates patient data that is existing at the time the project is submitted to the IRB for initial review. A Prospective Chart Review evaluates patient data that does not yet exist at the time the project is submitted to the IRB for initial review.
A cohort study can be prospective (researchers formulate their hypothesis before data collection). For a prospective cohort study, Level of Evidence = II. Or a cohort study can be retrospective (researchers formulate their hypothesis after data collection). For a retrospective cohort study, Level of Evidence = III.
A retrospective study uses existing data that have been recorded for reasons other than research. In health care these are often called chart reviews because the data source is the medical record. Figure 1 contrasts retrospec- tive and prospective studies.

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