Prospective Observational Study Protocol Template
Instructions
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.
Study Protocol Title:
Be consistent with the Title through out your research application, protocol, and IRB documents.
Principal Investigator, Research Team, and Study Site:
Research team and contact Information:
Principal investigator:
Co-Investigators:
Study site address:
Table of Contents:
After completing the protocol, insert a list of your sections accompanied by the page number
List of Abbreviations:
Use commonly used abbreviations and acronyms.
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”
Sample Text: This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice in accordance with applicable Federal regulations, International Conference on Harmonization guidelines, and institutional research policies and procedures.
Background Information and Scientific Rationale
Summary of Previous Pre-clinical Studies/ Relevant Clinical Studies
Summarize the available clinical study data (published or available unpublished data) with relevance to the protocol under construction -- if none is available, include a statement that there is no available clinical research data to date on the investigational product.
Summary of Epidemiological Data
Describe the disease including incidence
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.
Potential Risks and Benefits
Potential Risks
Sample Text: As this is an observational study, there are no physical potential risks to research subjects.
Potential Benefits
Sample Text: As this is an observational study, there are no physical potential benefits to individual research subjects.
Describe potential benefits to science for this clinical trial.
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: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis
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: 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
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.)
Sample text:
1. Age 18 – 90
2. Diagnosis of rheumatoid arthritis within past 2 years
3.
Exclusion Criteria
Create a numbered list of criteria that would exclude a subject from study enrollment. 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 should be noted here as well.
Sample text:
1. Current cardiovascular disease
2. Allergy to penicillin
3.
Sample Size
Include total number of patients for the study.
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 necessary, please provide the rationale.
Research Design
Sample text: This study is a prospective, observational study examining the relationship between treatment for rheumatoid arthritis and quality of life.
Type of study and design should be decided on the basis of proposed objectives and the
availability of the resources.
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. Of note, these must be extracted from the medical records of research participants after Informed Consent has been obtained. These endpoints must be part of the research subject’s regular clinical care.
Sample Text: Beck Depression Inventory-II (BDI-II): The BDI-II is a 21-item self-report instrument designed to assess symptoms of depression. Each item requires the research subject indicate which of 4 statements bests describes a symptom of depression that the research subject has experienced over the past 2 weeks.
Sample Text: Hemoglobin A1C (HgA1c): Hemoglobin A1c, also known as glycated hemoglobin, or glycohemoglobin, is a laboratory blood test used to provide an average of blood glucose control over a six to 12 week period.
Sample Text: Waist Circumference: Waist circumference (in inches) is an anthropometric measure of deep adipose tissue and has been associated with stroke risk.
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 “stand-alone” 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: Descriptive statistics (frequency, means, and standard deviations) will be calculated for all demographic and baseline levels of all clinical outcome variables or endpoints. Logistic regression analysis will be used to identify variables that best predict clinical outcomes.
Study Procedures
Subject Recruitment and Screening
Describe how subjects will be recruited for the study, e.g. from investigator or sub-investigator clinical practices, hospital admissions, etc. Note in this section that information to be disseminated to subjects (handouts, brochures, etc.) must be approved by the IRB for the site; include a sample of such information in the attachment section of the protocol. Describe procedures for obtaining informed consent from research subjects.
Study Duration
Note the estimated length of time to enroll human subjects in the study. Note the length of time until all data is abstracted from clinical records.
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. subject consent withdrawal, disease progression, etc.)
Quality Control and Quality Assurance
Plans for protocol compliance should be included.
Sample text: Quality control procedures for this research study include random selection of data points with comparison between the paper case report form (CRF) and the electronic database record of those same data. We will statistically examine the data with frequency distributions of outcome variables/endpoints to identify outliers or questionable data points that may represent data errors.
Ethical Considerations
Identify any ethical concerns and how you will address these.
Conflict of Interest
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has been reviewed and approved by the study sponsor prior to participation in this study.
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 here. If there is no subject stipend/payment, delete this section.
Publication Plan
Describe the plan for publication. 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. According to the International Committee of Medical Journal Editors:
· an ‘author’ is generally considered to be someone who has made substantive intellectual contributions to a published study
· biomedical authorship continues to have important academic, social, and financial implications.
· Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.”
· Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.
· All persons designated as authors should qualify for authorship, and all those who qualify should be listed.
· Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
· All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section.
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.
Protocol Date – xx/xx/20xx
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