Protocol #:
Confidential
SCRIHS Protocol Template for Exempt or Expedited Protocols
Instructions to User:
1. Sections and text that are in regular font and that have not been highlighted in
grey represent standard language. In general, these sections should be present in
your final protocol and the language should not be changed. However, every
protocol is unique and changes to standard sections and language may be necessary
to meet the needs of your protocol. Please review the language carefully to make
sure that it is accurate for your study.
2. Sections that are highlighted in grey, but that have regular font, represent sections
or information that needs to be customized as applicable to your study, but the
language that is present is generally considered to be standard if that section (or
procedure) applies to your protocol.
3. Sections that are highlighted in grey, and where the text is italicized, represent
instructions with some example text. All require complete customization for your
study.
4. As you customize each section of the protocol, remove the highlighting and restore
the font to regular (from italics) to denote that section as having been completed.
5. When your protocol is complete, review it to ensure that all highlighting and italics
have been removed.
6. Inclusion of relevant cover letters, data collection forms, questionnaires or any other
relevant documentation should be submitted to IRIS in addition to this protocol.
7. Once a document has been uploaded into IRIS any subsequent changes must be
completed through the use of revisions. DO NOT upload a revised or modified
document as a new document in IRIS. Documents that have been uploaded or
submitted incorrectly may cause a delay in study review.
8. Please do not include this instructions page when submitting.
9. Contact the SCRIHS office if you have any questions or problems prior to submitting.
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Version date: 6/28/2016
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Protocol #:
Confidential
TITLE
Principal Investigator:
Co-Investigators:
Performance Site:
BACKGROUND
Briefly explain the significance of your study with citations from relevant references.
STUDY RATIONALE
Describe why it makes sense to conduct this study. Why is this information needed? Describe
your plans for the information once collected.
STUDY OBJECTIVES
State the primary and secondary OBJECTIVES, if applicable.
STUDY DESIGN
Insert a very short description or outline of the study procedures. Explain how the study will be
conducted.
SUBJECT SELECTION
Please include a description of the population to be studied, number of subjects to be enrolled,
charts to be reviewed or samples to be collected. Include inclusion and exclusion criteria, if
applicable. If consent is needed, how will it be obtained and by whom? Please include Informed
Consent document with submission.
RISK / BENEFIT ASSESSMENT
Please describe why the risks to the patients are minimal and therefore eligible for expedited
review. Indicate if there will be any costs or compensation to the subjects.
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Protocol #:
Confidential
STATISTICAL METHODS AND CONSIDERATIONS
Describe the statistical methods to be employed for the primary and secondary outcomes, if
applicable. Indicate the timing of any planned interim analysis(es), if applicable. Specify the
number of subjects planned to be enrolled and describe the reason for choice of sample size
including reflections on (or calculations of) the power of the study, if applicable and clinical
justification. For example: The sample size for this protocol was determined by xxxx.
DATA COLLECTION, RETENTION AND MONITORING
Describe procedures for protecting the privacy of the subjects and maintaining confidentiality of
the data and/or specimens. How will you be acquiring your data? If retrospective review, from
what date to what date (MM/DD/YYYY to MM/DD/YYY) will you be collecting data from the
patient’s medical record? Does your study require ongoing contact with subjects? Will you be
recording any identifying information? How will data and/or specimens be stored? Who will
have access to the data and/or specimens? How long will data and/or specimens be stored?
What are the plans for disposition of the specimens and/or any identifiable information upon
completion of the study?
REFERENCES
Please include any citations here.
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