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Clinical Protocol Development - Doc

   

Added on  2021-04-21

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Data Science and Big DataHealthcare and Research
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Running head: CLINICAL PROTOCOL DEVELOPMENTCLINICAL PROTOCOL DEVELOPMENTName of the StudentName of the universityAuthor’s note
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CLINICAL PROTOCOL DEVELOPMENT1Table of ContentsIntroduction....................................................................................................................................2Discussion.......................................................................................................................................2Aims of the protocol...................................................................................................................2Title of the study:.......................................................................................................................2Project summary:......................................................................................................................3Introduction/ background.........................................................................................................3Aims............................................................................................................................................3Hypothesis..................................................................................................................................4Methods and materials..............................................................................................................5Data Analysis..............................................................................................................................6Strengths and limitations..........................................................................................................6Ethical approval.........................................................................................................................6Budgeting system:......................................................................................................................6References...................................................................................................................................7Conclusion......................................................................................................................................7
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CLINICAL PROTOCOL DEVELOPMENT2CLINCAL PROTOCOL DEVELOPMENT IntroductionA clinical protocol is a document that illustrates how a clinical trial will be conducted. Itcontains the background, rationale, design, objective, methodology, selection and the exclusioncriteria, assessment of the efficacy, assessment of safety, adverse events, discontinuation of thestudy, statistical considerations, quality control and assurance, Ethical approval, data handlingand record keeping, publication policy, project time frame, references, Appendices (1). DiscussionAims of the protocolThe aim is to raise the research question and clarify the importance of the question,collect the current knowledge and review the findings of the other researchers who haveresearched on the related topic, formulation of the hypothesis and objectives, obtaining ethicalapproval from registered organizations, to propose a perfect method required for explaining thequestion for the achievement of the objective (2). Protocol writing enables a researcher to critically examine and evaluate the currentavailable works on a particular topic, design and review the levels of the project and finally helpsthroughout the conduction of the research work (3). Title of the study: It should be short, accurate and concise (3).The title should make the aim of the projectclear, convey the actual motive of the research, mentioning the primary stakeholders.
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