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Dr. Biju George Asst Professor Dept of Community Medicine Nodal Officer, IRC Medical College, Calicut Radar Networks 1
What is Protocol ?
Protocol is a set of rule which guides how an activity should be performed
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Give idea regarding procedures, required equipment, instruments, safety precautions, ways of calculation of results and reporting standards.
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Why is it important ?
Only well written protocol get grants and funding Writing / Presentation skills. It is a proud document to prove our capability to analyze a health problem. Help to avoid Bias and errors Help multiple centers to follow same thing
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Title
Concise titles are easier to read. Titles that are too short may, however, lack important information. Authors should include all information in the title that will make the topic both sensitive and specific
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Synopsis
Summary of protocol not more than a page It should summarize all the elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes It should stand on its own
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Study Objectives
Primary Objective Secondary Objective
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Study Design
Experimental Analytical Descriptive Reason why a specific design is chosen
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Methodology
the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection
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Methodology
Selection and Description of Participants
Selection
of participants (patients or controls), including eligibility and exclusion criteria and a description of the source population Authors should explain why only certain groups were included or why some groups were excluded
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Methodology
Technical Information
Source
of data How variables were define & measured. Describe methods, apparatus & procedures in sufficient detail Give references to established methods & Describe new or substantially modified methods, give the reasons for using them Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration.
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Methodology
Statistics analysis -plan
Statistical
methods with enough detail Sufficient details regarding the sampling strategy and adjustments for it How matching was done Plan of subgroup analysis What was done about missing of data / lost to follow up
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Methodology
Flow diagram
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Program Management
Role and responsibility of each member of the team Budget Other supports Collaborations
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References
References to key original works Should be verified using either an electronic bibliographic source, like PubMed or print copies Vancouver style of referencing
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Appendix
Questionnaires and interview schedules Informed consent form Detailed Budget Curriculum Vitae of the investigator and Co-investigators
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Develop a style
Be conscious of language and its potential Rewrite / revise Learn from good work Be direct, bold and brief Make the paragraph the unit of composition Use the active voice
Develop a style
Start on broad frames, make it finer as time progress Arrange the topics to each paragraph Take a break from writing often Come back later and read again the written part Re modify Working draft
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