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1. Purpose of the study –

The primary objective of this study is to____________. Secondary objectives include
_____.
Provide a brief description of purpose of the study. Your hypothesis.
2. Background & significance –
How did you get to this question, what has been studied in the past that helped to
generate your question? If you use references include them at the end of this submission
This section supports your scientific goals for the project
3. Design & procedures –
This retrospective review of patients with a diagnosis of______ will be collected from the
following (databases) between the dates of xx/xx/xxxx through xx/xx/xxxx. Only data in
existence as of xx/xx/xxxx will be used in this study. The following will be collected for this
study (include all data elements needed for your analysis). Include variables and
endpoints. All needs to be spelled out here. All eligible medical files (include ages if
applicable—minors must be clearly defined). It is anticipated that XXX medical files will be
reviewed and XXX patient files included in the study.
4. Selection of Subjects –
Patients will be identified using a search of diagnosis codes for… (include CPT/diagnosis
codes here) and procedure codes for (if a second item/condition detail it here & include
CPT/diagnosis code) and (item/condition detail it here & include CPT/diagnosis code, from
xx/xx/xxxx through xx/xx/xxxx. Patients may have had their initial appointments with any
member of the Duke insert clinic service faculty, and may be selected from the Duke Eye
Center main campus (if including satellite locations mention here).
Exclusion criteria will include any prior history of treatment with XXX in the affected eye(s).
All eligible candidates, age XX years and over, will be considered regardless of race or
gender. Each subject will be given a unique code that will identify them for this study.

Describe your study population. List inclusion and exclusion criteria. Remember
that if following a patient for any period of time all the follow-up data must be on the
shelf by the end date provided. No follow-up information can be collected where the
clinic visit will occur in the future—this will become a prospective study requiring
consent.
5. Subject recruitment and compensation –
No subjects will be recruited for this retrospective study. However, they will be identified
for this study in the manner described above. There will be no direct compensation to
subjects.
6. Consent process –
Not applicable as this is a retrospective chart review project.

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7. Subject’s capacity to give legally effective consent –

Not applicable as this is a retrospective chart review project.
8. Study Interventions –
This retrospective study will not necessitate any intervention. All study data will have been
in existence prior to this study.
9. Risk/benefit assessment –
There are no direct risks or benefits to subjects recruited to this study. There will be no
study interventions and no direct contact with patients additionally, the patients’ identities
will not be identifiable in publications resulting from this investigation. Potential risk may
include having the patient’s privacy or confidentiality compromised. But every reasonable
effort will be made to protect the patient’s information while their data is used as part of
this study.
10. Costs to the subject, and compensation –
There are no costs that will be incurred by subjects involved in this retrospective study.
11. Data Analysis and Statistical Considerations –
Standard statistical methods will be used in analysis of data collected. Data will most
likely be presented as the number of cases in each measured category compared to total
number of cases overall, as well as the percentage of the total that each category
represents.
Please consider working with the Department’s Biostatistician, Dr. Sandra Stinnett.
Remember to have clear definitions of endpoints, include any statistical software programs
to be used for data analysis. Describe statistical methods to be used for each objective.

12. Data & Safety monitoring – As a retrospective chart review study, there is minimal
risk to the subjects except the potential for loss of privacy and confidentiality, but every
reasonable effort will be made to protect the patient’s information while their data is used
as part of this study.
13. Data storage & confidentiality –
Data will be stored either within a locked office/suite or on a password-protected computer
with the data maintained on a secure Duke server. Subjects will be de-identified via the
use of a separate document correlating subjects’ Duke medical record numbers with a
study ID assigned for the sole purpose of this study. At the end of data collection, that key
will be destroyed. No social security numbers, names, addresses or other personal
information will be recorded. . Files will not be shared with non-study personnel.

Please make sure that the information in section 12.1 of the Duke e-IRB (Research Data
Security Plan [RDSP]) matches what is stated in this section. Do not say: refer to section
12.1 for the RDSP. The information must be clearly included in both sections.

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Any presentations or publications that result from this study will not identify any subjects
individually and may present the data results in an aggregated form.

REFERENCES:
Add if applicable

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