Writing a Research Protocol by jox66113

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									CTEO TIP SHEET |                 Writing a Research Protocol


First Steps

       Have a good idea!

       Know the difference between a grant proposal and a research protocol.

                           Grant Proposal                    Research Protocol
        Purpose            Obtain funding                    Regulatory document describing
                                                             single study in detail
        Focus              Describes aims, methods,          Organized around objectives of
                           hypotheses                        study
        Feasibility        Costs, staffing, equipment        Specifics of enrolling,
                                                             implementation details
        Tone               Persuasive                        Informative; focused on details

       Determine your study objectives. These should be clearly defined and attainable.


Start Work

       Review the latest literature.

       Generate measures of exposure and outcome. Consider how others have defined/measured the
        exposure and/or outcome.

       Consult with your DF/HCC biostatistician. The statistical power of a study should be an early
        consideration, and investigators should draw on professional statistical advice to avoid unnecessary
        or unproductive studies.

       Draft a concept first and ask others to review it.


Start Writing

       Use the DF/HCC Biomedical Protocol Template or guidance document most appropriate to your
        study. These are located on the DF/HCC website in the Clinical Investigator Toolkit. The toolkit is
        accessible through the Clinical Trials Portal.

       Assign writing tasks to others when appropriate.

       Be specific about data requirements. Outline what data is needed, when it needs to be collected,
        how often it needs to be collected, and how it will be analyzed.




       TIP SHEET   Writing a Research Protocol
                   Last updated August 2008
                   1
    Use checkpoints to maintain design consistency. The research question(s) must be measurable by
     the response variables and recorded on the data collection forms in a format suitable for statistical
     analysis. As each section of the protocol is written, cross-check it with other segments for
     agreement.

    Minimize the likelihood of protocol amendments, where possible. Consider the strictness of the
     eligibility criteria and consider whether any flexibility can be incorporated into the protocol to
     minimize the need for substantial protocol amendments. For example, changing the age range in a
     study from, say, 18-70 to 18-75 in order to increase the rate of accrual is less likely to affect the
     safety of a study than a change in age range from, say 18-70 to 14-70.

    Spell out abbreviations and acronyms at first use. Even the most well known acronyms.

    Utilize version numbers and version dates during the drafting process. The final protocol that is
     submitted to the SRC/IRB should ideally be numbered version 1.0 with the date of finalization of
     the protocol.

    Apply the CATS standard to your title. Keep it Concise, Accurate, To the Point, and Short.

    Proofread the document. Correct any typographical errors, misspellings, or sloppy formatting.

    Don’t panic or give up if your protocol isn’t approved the first time. The SRC/IRB review critiques
     can be used to improve the protocol so that it does better the next time it is reviewed.




    TIP SHEET   Writing a Research Protocol
                Last updated August 2008
                2

								
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