ITHS Sample Basic Protocol Template
<Protocol Title>
Principal investigator:
Co-Investigators:
Research team and contact Information:
Study site:
Protocol Version/Date: <Version #, dated mm/dd/yy>
<< The ITHS basic protocol is meant to be a document to explain key features of study purpose,
study design, study population, procedures, timeline, and participant safety in order to ensure that
your study is conducted in a safe and reproducible manner on the UW Clinical Research Center.
The template provided here is the minimum amount of information required and is not reflective
of a complete study protocol that may be required by a study Sponsor, IRB or regulatory agency.
If you already have a protocol document that contains the basic elements described in the
following pages you may submit that in lieu of completing this template. Alternatively you can find
a complete protocol template at:
https://www.iths.org/sites/www.iths.org/files/forms/IND/Protocol_template.dotx. The length of a
protocol will depend on the complexity of the study. Please contact the ITHS Research
Coordinator Core (RCC) at rccore@uw.edu if you would like assistance with developing a
complete protocol. If you have questions or need assistance in completing this basic template
please contact the RSB core at rsbcore@uw.edu.>>
Template Version 1, dated 06/08/12
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ITHS Sample Basic Protocol Template
Contents
Research Synopsis .......................................................................................................................... 3
Background and Significance .......................................................................................................... 4
Objectives ........................................................................................................................................ 4
Primary Objective ........................................................................................................................ 4
Secondary Objectives ................................................................................................................. 4
Study Design and Methodology....................................................................................................... 4
Study Population.............................................................................................................................. 4
Sample Size ................................................................................................................................ 4
Inclusion /Exclusion Criteria ........................................................................................................ 4
Study Duration, Timeline, and Procedures ...................................................................................... 5
Informed Consent Process .............................................................................................................. 5
Risk to Participants .......................................................................................................................... 6
References ...................................................................................................................................... 6
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ITHS Sample Basic Protocol Template
Research Synopsis
<<The synopsis should provide a brief, one page summary of the information that is detailed later
in your protocol. It gives a quick, helpful snapshot of your study for anyone needing to reference
it, especially for protocols that are lengthy.>>
Study Title: <Enter the full title>
Study Population: <Summarize inclusion/exclusion criteria. Include a brief description of the
population such as health status, gender, age, etc.>
Study Design: <Present an overview of the study design for example, retrospective chart review,
data or specimen collection etc.>
Sample Size: <Include total number of participants for the study including other sites.>
Study Duration: <Length of time from enrollment of first subject to completion of data analysis
Primary Objective: <Include primary objective and outcome measures.>
Secondary Objective(s): <Include secondary objective and outcome measures.>
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Background and Significance
Give a 2-3 paragraph summary of existing knowledge relevant to your research question. This
may be similar to the “background and purpose” section for your IRB application.
Objectives
Primary Objective
<Include the details of your primary objective (which is your main purpose of performing this
study and should be focused on one question), outcome measures, and method by which
outcomes will be determined.
Sample text: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis.>
Secondary Objectives
<Include secondary objectives which can be dependent or independent of the primary objective,
outcome measures, and method by which secondary outcomes will be determined.
Sample text:

To assess patients overall change in symptoms and return to daily activities after 2
weeks of antibiotic treatment.

To evaluate management and treatment factors as potential predictors of outcome.>
Study Design and Methodology
<Include the description of study type, for example prospective data or specimen collection,
retrospective, or observational, survey, or questionnaire.
Sample text: This is a cross-sectional study to evaluate prevalence of xx in the general
population.….>
Study Population
Sample Size
<Provide total number of participants to be enrolled at all sites and indicate any per site
enrollment targets or caps, if applicable.
Inclusion /Exclusion Criteria
<What are the criteria for including or excluding any particular population? >
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Study Duration, Timeline, and Procedures
<Briefly state the stages of your study, for example:

Stage 1, Participant recruitment ----4-6 months

Stage 2, Participant follow up ----8-12 months

Stage 3, Data analysis, presentation and publication ----6-12 months
Include a projected start date.
Provide the total length of time and include an approximate end date of the study.
Include length of time participants will be followed
Provide Table of Procedures: Procedures to be done in each study visit including examination,
questionnaire, laboratory evaluation, medication administration and dosing, and the study
schedule in the form of a flow chart or table.
Example:
Follow-Up Schedule:
Week
Screen
Enroll
Signed Consent Form
X
Assessment of Eligibility
Criteria
Review of Medical History
X
X
X
X
Review of Concomitant
Medications
Study Intervention
X
X
1
2
3
4
X
X
X
X
X
X
Study questionnaire
X
X
X
X
X
Labs: CBC, Chem 7, LFT
X
X
X
X
X
Include a list of all laboratory evaluations, if applicable.>
Informed Consent Process
<Insert sample text.
Please outline your process for conducting informed consent. Include information about any
alternate methods that may be used like conducting consent by phone. Some sample language
is provided below which you can use or modify to fit the nature of your study.>
“Informed consent is a process that is initiated prior to the individual’s agreeing to
participate in the study and continuing throughout the individual’s study
participation. Extensive discussion of risks and possible benefits of participation
in this study will be provided to the participants and their families. Consent forms
describing in detail the study procedures and risks are given to the participant
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ITHS Sample Basic Protocol Template
and written documentation of informed consent is required prior to enrolling in the
study. Consent forms will be IRB approved and the participant will be asked to
read and review the document. Upon reviewing the document, the investigator
will explain the research study to the participant and answer any questions that
may arise. The participants will sign the informed consent document prior to
being enrolled in the study. The participants will have the opportunity to discuss
the study with their surrogates or think about it prior to agreeing to participate.
The participants may withdraw consent at any time throughout the course of the
study. A copy of the informed consent document will be given to the participants
for their records. The rights and welfare of the participants will be protected by
emphasizing to them that the quality of their medical care will not be adversely
affected if they decline to participate in this study.”
Risk to Participants
<Describe in detail any physical, psychological, social, legal, economic or any other risks to
participants that are reasonably foreseen (i.e. were observed in previous studies or as outlined in
the study drug package insert, investigator’s brochure or device manual)for all study procedures
being conducted, including administration of study drug or use of an investigational device. This
does not need to be an exhaustive list of all possible risks but it should include those risks that
will be included in the consent form.>
References
<List all the references used in the background section at the end of the protocol.>
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