INSTRUCTIONS: • Use this RECORDS REVIEW PROTOCOL TEMPLATE to prepare a document

INSTRUCTIONS:
• Use this RECORDS REVIEW PROTOCOL TEMPLATE to prepare a
document with the information from following sections. This version is
to be used for “records review” studies only.
• Please remove all instructions in red so that they are not contained
in the final version of your local protocol.
1) Study Title
Include the full protocol title as listed on the application form.
2) Objectives
Describe the study purpose, specific aims, or objectives.
3) Background
Describe the relevant prior experience and gaps in current knowledge.
This section will have literature to give the reader a full understanding of
the topic.
4) Inclusion and Exclusion Criteria
Describe the criteria that define the type of records to be included or
excluded in your final study sample.
Indicate specifically whether you will include or exclude each of the
following special populations: (You may not include members of the
below populations as subjects in your research unless you indicate this
in your inclusion criteria.)
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
5) Procedures Involved
Describe and explain the study design.
Research Proposal Template
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Describe how the records to be reviewed will be identified.
Describe the type of data to be collected; upload a Data Collection Sheet
to the Supporting Documents section of the IRBNet application.
Provide the date range of the records review (if this is a retrospective
chart review, the end date must come before the IRB submission date):
mm/dd/yyyy to mm/dd/yyyy
6) Data Management
Describe the data analysis plan, including any statistical procedures.
7) Risks/Benefits
Describe the risks/benefits as a result of access to the records.
Examples given below.
This study is a retrospective chart review; as such, patient information will be
collected from the medical records (CERNER). Although every measure will be
taken in order to prevent any possible compromise of patient data (safe storage,
password encryption, limited access, etc), the risks associated with possible
disclosure of patient data are present. The risks include attainment of patient
information by some third party – how they could use this information even if it
were compromised, is not easily foreseen. Identifying variables (name, MRN, etc)
will not be stored to minimize the risks, simply the variables that we are interested
in. Although disclosure of patient information is conceptually possible, it is highly
unlikely seeing as how we will take every possible precaution and not store any
identifying information with the data.
The benefits include the possible identification of variables that affect patient
outcome and the ways to correct them. We will gauge how our institution as a
whole is performing in the treatment of [name disease/condition] and identify areas
that we can improve. This information will eventually allow us to become more
efficient overall with handling this patient population, allowing for shorter time to
treatment and improving patient outcomes as a whole.
8) Setting
Describe the sites or locations where your research team (specifically
indicating from where records will be accessed) will conduct the research;
specifically, where records will be reviewed and stored.
9) Resources Available
Describe the qualifications (e.g., training, experience, oversight) of you
and your staff as required to perform their role. Provide enough
information to convince the IRB that you have qualified staff for the
proposed research.