Prospective Observational Research Study Protocol Template
(For non-interventional studies)
This template should be used for non-interventional research that involves collecting
information for the purpose of answering study questions. Non-interventional refers to
patient/subject treatment decisions that are determined as part of normal patient care and are
not changed by the research study. Additional research procedures or outcome measures may
be included in this type of research, but does not alter the standard intervention the
patient/subject would normally receive.
Instructions (Delete this section prior to submission)
This protocol template can be used by investigators to develop a research study protocol for
investigator initiated studies. It contains sections typically seen in a protocol. However, there
are some sections that will not be needed in every study and “n/a” should be noted or the section
should be deleted. Instructions and/or sample text is provided in blue font to generate ideas of
what should be included in some of the sections. This should be deleted and substituted with
information that pertains to the actual study. Delete this “Instructions” section from your final
protocol. It is permissible to rearrange the sections of the protocol if doing so creates a more
logical flow for your specific protocol. Two example protocols are given as sample text in green
font and orange font, delete these examples.
Study Protocol Title:
Be consistent with the Title throughout your research application, protocol, and IRB documents.
Principal Investigator, Research Team, and Study Site:
Research team and contact Information:
Principal investigator:
Sub-Investigators:
Study site address:
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Table of Contents:
In order to have Word automatically create or modify your Table of Contents, do the following:
1. Make sure that any additional sections are labeled as Heading 1 (Home
Tool Bar above) – put cursor at the front of the Heading and click
Heading 1. Subsections should be listed as Heading 2 (Home Tool Bar
above).
2. When all sections are entered, come to this page and click on the
References tab, under Table of Contents, pick Update Table. Select Update
entire table and click ok.
List of Abbreviations: ..................................................................................................................... 4
Introduction ..................................................................................................................................... 5
Background Information and Scientific Rationale ......................................................................... 5
Summary of Previous Studies ..................................................................................................... 5
Rationale ..................................................................................................................................... 5
Study Objectives ............................................................................................................................. 5
Primary Objective ....................................................................................................................... 5
Secondary Objectives.................................................................................................................. 5
Study Design ................................................................................................................................... 6
Research Design.......................................................................................................................... 6
Sample Size................................................................................................................................. 6
Subject Selection ......................................................................................................................... 7
Inclusion Criteria .................................................................................................................... 7
Exclusion Criteria ................................................................................................................... 7
Study Outcome Measures (Endpoints) ....................................................................................... 8
Study Procedures ............................................................................................................................ 8
Subject Recruitment and Screening ............................................................................................ 8
Randomization ............................................................................................................................ 8
Study Visits (if appropriate)........................................................................................................ 9
Study Duration ............................................................................................................................ 9
Data Quality Plan ........................................................................................................................ 9
Statistical Analysis Plan ............................................................................................................ 10
Potential Risks and Benefits ......................................................................................................... 10
Potential Risks .......................................................................................................................... 10
Potential Benefits ...................................................................................................................... 11
Withdrawal of Subjects ................................................................................................................. 11
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Ethical Considerations .................................................................................................................. 11
Conflict of Interest ........................................................................................................................ 11
Funding Source ............................................................................................................................. 12
Subject Stipends or Payments ....................................................................................................... 12
Publication Plan ............................................................................................................................ 12
References ..................................................................................................................................... 13
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List of Abbreviations:
Use commonly used abbreviations and acronyms.
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Introduction
The introduction should open with remarks that state that this document is a clinical
research protocol and the described study will be conducted in compliance with the
protocol, Good Clinical Practices standards and associated Federal regulations, and all
applicable institutional research requirements. The rest of the introduction is broken out
into subsections. Example language for the first paragraph under “Introduction” is
given below.
Sample Text: This document is a protocol for a human research study. This study is to be
conducted according to United States standards of Good Clinical Practice in accordance
with applicable Federal regulations and institutional research policies and procedures.
Background Information and Scientific Rationale
Summary of Previous Studies
Summarize the available study data (published or available unpublished data) with
relevance to the protocol under construction -- if none is available, include a statement
that there is no available research data to date on the topic being investigated.
Rationale
This section is based on your research question. How would you answer the questions
and give explanations to your answer? What are the assumptions and relationships?
Justification of your conducting this study based on existing knowledge and your
research question.
Study 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: The primary objective of this study is to investigate the potential benefits of
MRI distraction goggles used with children. Procedure time, procedure completion rate
and parent generated experience scores will be collected.
Sample Text: Does a designated “quiet time” in the CVICU, decrease the noise level,
during specified hours?
Secondary Objectives
Include secondary objectives which can be two or three can be dependent or independent
of the primary objective, outcome measures and method by which secondary outcomes
will be determined.
Sample text: The secondary objective of this study will assess the financial impact of
purchasing MRI distraction goggles.
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Sample text: The secondary objective will be to ask nurses if they notice a difference in
the noise level during “quiet time” hours.
Study Design
Research Design
Include the description of study type (randomized double-blinded, placebo-controlled,
parallel, etc…), number of study arms, and other study details.
Include a description of the study population. If this study intends to enroll children,
pregnant women, prisoners or other vulnerable populations, please check applicable
sections of 45 CFR 46 for information.
Type of study and design should be decided on the basis of primary and secondary
objectives and availability of resources.
Sample text: This study is a prospective, randomized two arm study examining procedure
time, procedure completion rate and parent generated experience scores from children
either wearing the MRI distraction goggles or not wearing the MRI distraction goggles.
Parents will be asked to complete an informed consent. After enrolling in the study,
patients will be randomized to one of the two treatment groups. At the completion of the
MRI procedure, parents/guardians will be asked to complete a questionnaire with
general questions regarding the MRI experience.
Sample text: This study is a prospective observational study examining decibel readings
during designated “quiet time” hours as compared to historic readings for the CVICU
(Orlando Campus). During the study period (February 1, 2012 ending on February 29,
2012), “quiet time” hours will be standard of care. Decibel readings will be taken every
hour every day of the study period. Readings during “quiet time” will be compared to
other hours and to previous levels registered in the CVICU from the past year.
Nurses will be asked to complete a brief questionnaire with two general questions about
the perceived noise level in the CVICU. No identifying information will be asked and no
record of completion will be kept. Questionnaire completion will state in writing that
participation is not mandatory.
Sample Size
Include total number of subjects for the study including other sites. Include sample size
plus an estimate for screen failures.
Describe how the sample size was determined for this study. The sample size should be
based upon the primary outcome variable. If the authors have determined that sample
size estimation was not computed, please provide the rationale.
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Sample Text: The primary outcome measure is procedure time (minutes). For this
particular study there is an average of 8 children a day scheduled for MRI’s and using an
enrollment percentage of 40% for the 40 days, the resulting sample size would be 160
participants. Using this information along with an estimate of variability, the study has
power of 84% chance of detecting a difference of 4 minutes.
Sample text: There will be 29 days in the study. The number of days was determined
based on input from nursing staff and management.
Subject Selection
Inclusion Criteria
Create a numbered list of criteria subjects must meet to be eligible for study
enrollment (e.g. age, gender, target disease, concomitant disease if required, etc.)
Generally should include items such as: “subjects are capable of giving informed
consent”, or if appropriate, “have an acceptable surrogate capable of giving
consent on the subject’s behalf.”You should consider clinical aspects that are
appropriate for your protocol such as: number of symptoms, length and/or
severity of symptoms.
Sample text:
1. Child must be 5-12 years of age
2. Able to wear MRI distraction goggles
3. Mentally capable of comprehending video
4. Parent or legal guardian willing to sign informed consent
Sample text:
1. Any nurse working in CVICU (Orlando Campus) during the month of
February 2012.
Exclusion Criteria
Create a numbered list of criteria that would exclude a subject from study
enrollment. If appropriate, should generally include that subjects have active
drug/alcohol dependence or abuse history or would interfere with study
participation. If exposure to certain medications or treatments at screening is
prohibited, that must be noted in the exclusion criteria—if these are also
prohibited concomitant medications during the study period that should be noted
here as well. You should consider clinical issues that are appropriate for your
protocol such as: contraindications to the study interventions, abnormal lab
results, or history of cancer.
Sample text:
1. Undergoing MRI with sedation
2. Reporting a pain score of 8-10 on the Visual Analog Scale (30 minutes
prior to procedure)
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Study Outcome Measures (Endpoints)
In this section, provide a list of the endpoint variables to be studied along with a
description (and reference) of the endpoint variable. If the outcome measure is a nonstandard of care item that cannot be billed to an outside payor (please notate as such).
Sample Text: Procedure time (min): The time, in minutes, from the child entering the
MRI suite until the child leaves the MRI suite. Technologist will record starting and
ending time directly on the Case Report Form (see Appendix).
Sample Text: Procedure completion (yes, no): The technologist will record whether or
not the MRI was completed without interruptions.
Sample Text: Parental Experience score (Likert scale): The parent will be asked (at the
completion of the procedure) by the technologist to score the experience on a scale of 1
to 5 for the following items – physical environment, child comfort, use of time.
Sample Text: Noise level (decibels): The average noise level for the unit measured by
Extech brand decibel meter; calibrated daily for research personnel, recorded on study
log. The device can keep up to 24 hours of average readings prior to overwriting. Study
personnel will record hourly values daily on the study log (see Appendix A).
Study Procedures
Subject Recruitment and Screening
Describe how subjects will be recruited for the study, e.g. from investigator or subinvestigator clinical practices, referring physicians, advertisement, etc. Note in this
section that information to be disseminated to subjects (handouts, brochures, etc.) and
that any advertisements must be approved by the IRB for the site; include a sample of
such information in the appendix section of the protocol.
You may list any screening requirements such as laboratory or diagnostic testing
necessary to meet any noted inclusion or exclusion criteria. However, this information
should also be listed in the “Study Design/Subject Selection” section of the protocol.
Sample Text: Subjects will be recruited from pediatric patients scheduled for an MRI
procedure. Parents/legal guardians will be asked about participation in the study.
Informed consent will take place in the MRI waiting room prior to the procedure. A
trained and qualified team member will conduct the informed consent process.
Sample text: There is no informed consent or screening as part of the study design.
Nursing staff will be given a questionnaire with specific wording (letter of invitation)
regarding the anonymous, voluntary nature of the questionnaire. By completing the
questionnaire and returning it to a designated envelope, they are participating.
Randomization
Describe how subjects are going to be randomized.
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Sample Text: Randomization will be done using statistical software by a trained team
member. The information will be released as the patients are prepped for the MRI
procedure. A master list of the patient names and intervention group will be kept in a
locked file drawer in the research office.
Sample text: There is no randomization as part of the study design.
Study Visits (if appropriate)
In this section, describe all the procedures and treatments required at each visit, broken
out by visit. Create a study procedures flowchart/table that describes the activities and
procedures to be followed at each visit. Include this flowchart/table in the Attachment
section and refer to that attachment in this section.
Include a projected start date. Provide the total length of time participants will remain in
the study including the active intervention and follow up period. Include an approximate
end date of the study.
Sample text: After patients have been screened and parents/legal guardians have signed
informed consent, those patients in the treatment group will be instructed on the use and
placement of the distraction goggles. Patients in the control group will be provided
standard medical treatment for the MRI procedure. After the procedure, the parent/legal
guardian will complete the questionnaire regarding the experience.
Sample text: There are no study visits.
Study Duration
Define the length of time each individual subject will be followed. Also specify the
approximate length of time to enroll subjects in the study until the completion of the study
(time should encompass statistical analysis and publication).
Sample Text: Subjects are only followed immediately before, during and after the MRI
procedure; this time will be approximately 90 minutes. The study duration will be:
Study prep time: 20 days
Study initiation: 40 days
Study data entry: 30 days
Study analysis: 30 days
Study publication: 9 months
Sample text: Duration of data collection will be 29 days. Data entry, statistical analysis
and reporting will take an additional 3 months to complete.
Data Quality Plan
Describe how the data quality is going to be checked. If appropriate, describe what
information if any will be collected on withdrawn subjects.
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Sample Text: Data quality control procedures for this research study include source data
verification by randomly selecting 10% of subject records with comparison between the
paper case report form (CRF) and the electronic database record of those same data.
Additional data verification may be implements depending on the results.
If any subjects are withdrawn from the study, the patient count will be noted and the
reasons for withdrawal will be recorded. These subjects will not be included in the
statistical analysis.
Sample text: Data quality control procedures for this research study include source data
verification by reentering all decibel readings and comparing both electronic versions.
Discrepancies will be resolved using the original source documents.
Statistical Analysis Plan
Summarize the overall statistical approach to the analysis of the study. The section
should contain the key elements of the analysis plan, but should not be a reiteration of a
detailed study analysis plan. The full Statistical Analysis Plan can then be a “standalone” document that can undergo edits and versioning outside of the protocol and
therefore not trigger an IRB re-review with every version or edit –AS LONG AS THE
KEY ELEMENTS OF THE ANALYSIS PLAN DO NOT CHANGE. The key elements
should be described in this section.
Be clear on primary as well as any applicable secondary analyses for Primary Aims and
Secondary Aims.
Sample Text: Means and standard deviations will be calculated for procedure time and
compared for the two treatment groups using a statistical test for two independent
samples. For procedure completion and experience scores, frequency distributions will
be used for summary measures. Comparison between treatments groups will be
conducted using independent proportion tests or chi-square independence testing or an
equivalent non-parametric test.
Sample text: An average decibel reading for “quiet time” hours will be compared to the
historic decibel average for CVICU and also to the non-quiet time hours. These
statistical tests will be conducted as a one-sample means test and as two sample
independent means test, if appropriate.
For nursing staff questionnaires, summary measures will be frequency distributions.
Potential Risks and Benefits
Potential Risks
Describe potential risks (physical, psychological, social, or any other risk) to individuals
participating in this study. Note: Include loss of privacy as an anticipated potential risk.
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Sample Text: Patients may have an adverse emotional reaction to the distraction goggles
which results in removal of the goggles. Previous studies have indicated the risk is very
minimal. There is a potential risk regarding loss of privacy.
Sample text: It may be possible that by creating “quiet time” hours, noisy procedures are
occurring more frequently and increasing the decibel level during the other hours.
Potential Benefits
Describe potential benefits to the individual research subject (economic, physical, or
other) as well as the benefits to science for this clinical trial.
Sample Text: Patients may have an easier time remaining relaxed and still during the
procedure.
Sample text: It may be possible that by creating “quiet time” hours patients have a
longer rest or sleep period which may promote healing.
Withdrawal of Subjects
This section describes when and how to withdraw subjects. Describe the scenarios under
which a subject may be withdrawn from the study prior to the expected completion of that
subject (e.g. safety reasons, failure of subject to adhere to protocol requirements, subject
consent withdrawal, disease progression, etc.)
Sample Text: Subjects that indicate (verbally or non-verbally) that they prefer not to
wear the goggles at any point prior to or during the procedure will be withdrawn from
the study. If during the procedure the patient seems distressed by the goggles, the
procedure may need to be stopped and the goggles removed. In these situations, the
subjects will be withdrawn from the study.
Sample text: N/A
Ethical Considerations
Identify any ethical concerns and how you will address these. Address subject rights
such as, allowing subjects in the control group access to the treatment after study
completion, if appropriate. Note: If including or targeting vulnerable populations explain
additional measures you will implement in order to protect their rights.
Conflict of Interest
Note: Florida Hospital requires every investigator to complete a Conflict of Interest form
every 12 months and update as needed. If a real or perceived conflict of interest is
identified (by ORA staff), describe the conflict of interest management plan.
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Funding Source
This section should describe how the study will be financed, but should not contain
specific dollar amounts (e.g. “This study is financed through a grant from the US
National Institute of Health”, or “… a grant from the American Heart Association”, etc.)
Subject Stipends or Payments
Describe any subject stipend or payment or gift here. If there is no subject
stipend/payment, state that participants will not be reimbursed for their participation.
Publication Plan
Describe the plan for publication.
Note: To the extent possible, roles and responsibilities of each research team member
should be determined in advance. Additionally, if the research study will be published,
there should be an additional plan that describes assignment of authorship and the
contributions of each author. International Committee of Medical Journal Editors
(ICMJE) has a policy to guide authorship; the details are provided on the ORA website
under Protocol Development tab (Worksheet for Identifying Investigators and
Authorship.doc)
https://drupal02.floridahospital.org/researchadmin/content/research-types
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References
This is the bibliography section for any information cited in the protocol. It should be organized
as any standard bibliography.
1. Author, Title of work, periodical and associated information.
2. Author, Title of work, periodical and associated information.
Note: Appendices should be included after references.
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