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Department of Medicine – Simple Research Protocol
Version 1 – August, 2013
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Department of Medicine Simplified Research Protocol Template
Every research protocol will be different. This will depend on the study design and
requirements. In general the protocol should contain all information required for the
research project to operate smoothly. Study team members should be able to use the
protocol as a reference document for evaluation and monitoring purposes. This document
is made to help you start your protocol but can me modified or changed as needed.
A basic research protocol will contain the following general areas:
1. Background & Scientific Justification
2. Research Hypothesis & Objectives
3. Methodology
i.
Study design
ii.
Study population
iii.
Outcomes/endpoints
iv.
Study procedures
v.
Data collection management
vi.
Timeline
4. Data & Statistical Analysis
5. Ethical Considerations
6. Limitations
7. References
Background & Scientific Justification
Provide a background literature review with appropriate references. Provide a clear
statement of purpose. Within this section you want to clearly frame the research by
providing an overview of the current state of knowledge/care and describe why there is
need of change/improvement/research, and why the knowledge which will be gained is of
interest to clinicians, patients, or administration. A well-framed research question is
crucial. Make use of databases such as MEDLINE, EMBASE, Cochrane Library, and
AMED.
Research Hypothesis & Objectives
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Provide a succinct statement of the hypotheses, or research question and research
objectives. The objective(s) should be listed as short statements of the scientific goals of
the study.
An effective research question or hypothesis is focused and precise, and outlines what the
research is proposed to achieve, and helps define exactly what data is required to answer
the research question. This is typically given in the PICOT format1, which stands for:
Population – patients with X exposed to Y
Intervetion (if applicable) – treated with Z
Control (or comparision) – compared with patients who were administered Q
Outcome- experience a lower risk of R
Timeframe – over an S period.
Once you have your research question it is important to evaluate your question and
ensure that it is realistic, relevant, and novel.
Ensure the objectives are attainable within the given constraints of time, funding and
team members, and available data sources. Minimize the number of objectives to ensure
that the scope of the proposal is attainable.
Methodology
1. Study design: You can describe your study design in the context of the evidence
which will be used to draw your conclusions. Specifically, are you completing a
retrospective chart review, a prospective observational study, questionnaire or
meta-analysis. Will you be doing a descriptive, cohort, cross-sectional, or casecontrol study.
2. Study Population: Define the criteria for inclusion, recruitment and any
exclusion criteria for each group. Provide sufficient justification for your choices.
Include information about control population. For matching studies include
mating criteria and numbers of controls per case expected. Any efforts made to
reduce bias should be detailed.
3. Outcomes/Endpoints: Outcomes and endpoints are what is actually being
measured within the participant population. Clearly define primary and
secondary outcomes/endpoints to be measured. Outcome variables are often
called dependant variables. Predictor variables are those which may affect the
outcome of interest, also known as exposure or independent variables. Include
any co-variables, additional variables which may be relevant to the study
outcome. Co-variables may include age, or sex.
Discuss their importance and role in the analysis and interpretation of study
results
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4. Study Procedures: Describe, in chronological order where possible, the
procedures that each participant will undergo, which are solely for research
purposes(i.e. questionnaires) and which may be done for evaluation or treatment
of the participants condition. Include a schedule and approximate time for each
activity.
For a retrospective chart review describe how patient populations will be
identified, records accessed, specific data which will be collected/extracted and
the source of data which for each variables described above. It is also good
practice to establish clear rules for how to deal with missing or conflicting data
sources.
5. Data Collection and Management: Pursuant to UBC Policy #85, describe how
data be recorded, verified, stored, secured and confidentiality maintained for the
required 5 years following study completion. Be precise about both the methods
and means used (essentially, who, when, where). Create data forms specific for
the study and attach a sample of this form in section 9.8.
Collection and storage of personally identifying health information must be
justified, and if so, describe how the data will be stored, used and how you will
maintain patient confidentiality. Who has access to study data and who will
perform the analysis? How long will the data be kept, and how will it be
destroyed? Will the data be de-identified? If yes, who will have access to the
key?(Refer to Chapter 5 – Privacy and Confidentiality in the TCPS_2 for more
detailed instructions surrounding confidentiality and de-identified or anonymized
information2.)
6. Timeline: Provide a timeline for the project, and specifically who will perform
each of the steps outlined in the timeline. Estimate the time required for training
of team members, recruitment, data collection, analysis and expected time for
disseminating results. Remember that dissemination is a very integral part of
conducting ethical research.
Statistical Considerations& Data Analysis
1. Sample Size Justification: The sample size is typically justified based on the
primary objective of the study; restate the objective and relevant hypothesis and
outcome/endpoints.
State the final proposed sample size. Online calculators may be necessary to
calculate power or sample size, or a statistician may be necessary for more
complex situations. Examples of good power calculators include:
http://homepage.stat.uiowa.edu/~rlenth/Power/ and
http://www.stat.ubc.ca/~rollin/
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Power is typically at least 80%; Is the proposed sample size reasonable with
respect to the time, funding and environment in which the study will be
conducted? The Type I error rate (α) is typically set to 0.05 and 2-sided
hypothesis tests / confidence intervals are the most common – both of these must
be stated.
A sample statement may look the like the following: “A study of N (sample size)
patients will result in X% power to detect a minimum difference of Eff (effect size)
increase in survival in patients treated with (drug1) compared to the standard
treatment (drug2), using a 2-sided test with an  value of 0.05”
If you are doing a simple survey you should still have a sample size estimation to
ensure that your objectives can be met. Remember that the sample size will be for
complete surveys and not the number of surveys or questionnaires you send
out/administer. You should have an idea of the “non-response rate” to estimate
how many questionnaires will have to be administered to achieve the target
sample size.
2. Primary Analysis: Specifically, what analysis methods will be performed to
achieve the primary outcome. What contingencies (transformations or nonparametric methods) will you have if the assumptions of the proposed methods
are not met.
3. Secondary Analyses: Analyses supporting secondary objectives should be
specified here and in a similar manner as the Primary Objective. This may
include alternative analyses of the Primary Outcome, or analyses of subgroups,
or simply testing of alternative hypotheses from the Secondary Outcomes.
Correction of Type I error for multiple testing is not typically required for several
Secondary Objectives.
Ethical Considerations
Provide a statement about the level of risk of the proposed study. The TCPS_2 defines
minimal risk as that which poses no greater potential for harm than the participant would
expect in their everyday life, as it relates to the research2. Retrospective chart reviews
are deemed minimal risk. Describe any outstanding ethical issues not addressed in the
Methods including \privacy issues surrounding data collection and management.
Limitations
By identifying the limitations of the study it demonstrates that you have thought through
the experiment and are prepared to address obstacles or confines which will ultimately
affect the overall quality of the work and publication.
Examples include, how you will deal with missing data?
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References
Demonstrate that you have fulfilled your responsibility of finding current and
appropriate references to support the study.
Document References:
1. Harvey BJ, Lang ES, JR Frank, editors. The research guide: a primer for
residents, other health care trainees, and practitioners. Ottawa: Royal College of
Physicians and Surgeons of Canada; 2011.
2. Canadian Institutes for Health Research, Natural Sciences and Engineering
Council of Canada, and Social Sciences and Humanities Research Council of
Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving
Humans, December 2010.
3. CIHR Ethics Publications & Resources: http://www.cihr-irsc.gc.ca/e/29371.html
Additional Suggested Reading:
1. Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, et al.
(2007) Strengthening the Reporting of Observational Studies in Epidemiology
(STROBE): Explanation and Elaboration. PLoS Med. 4(10):e297 1628 – 1654
2. Gearing RE, Mian IA, Barber J, and Ickowicz A. (2006) A Methodology for
Conducting Retrospective Chart Review Research in Child and Adolescent
Psychiatry. J Can Acad Child Adolesc Psychiatry. 15(3): 126 – 134
3.
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