Protocol Writing Guidelines PDF

Protocol writing Dr. Alshimaa Hosseny Teaching Assistant Faculty of Medicine Arish University Objectives ◦ Understand the importance of research protocol. ◦ Identify the components of a research protocol. ◦ Title. ◦ Introduction. What is the Protocol? A research proposal is y...

Protocol writing Dr. Alshimaa Hosseny Teaching Assistant Faculty of Medicine Arish University Objectives ◦ Understand the importance of research protocol. ◦ Identify the components of a research protocol. ◦ Title. ◦ Introduction. What is the Protocol? A research proposal is your plan It describes in detail your study Decisions about your study are based on the quality of the proposal - Research funding - Approvals to proceed by the Institutional Review Board  Importance of research protocol ◦ State your research question ◦ Check if objectives can be achieved ◦ Acts as a guide to you, your supervisor and colleague of initial structure & aims of study. ◦ Obtain approval of ethical committee(s) Components of a research protocol 1. Cover page 2. Introduction & rational 3. Research question &hypothesis 4. Aim &Objectives 5. Subjects & Methods 6. Data management 7. Ethical considerations 8. Timetable 9. Budget 10. References 11. Appendices 12. Arabic summary Key points of your protocol What is your question? Why is your study important? How are you going to do it?  Cover page Title Researcher name & position Supervisors: name & position Department, University & Year This Page is translated to make a covering page in Arabic  Enter the Title of the proposal By Name of Candidate Supervisors Title. Name Academic position – College - University Title. Name Academic position – College - University Title. Name Academic position – College - University Faculty of Arish University 2024/2025  Title Is one of most important features because it is the 1st to attract attention of reader. Descriptive title identifying the population/problem, intervention, control/comparator, primary outcome & study design. Title better to be12-20 words, Capitalized the first letter of each word, Times New Roman, Font 16, Bold, Line space 1.5, Prepositions are small letters Introduction It could include 3-4 paragraphs exploring the following:- A. Definition of the problem B. What the literature says about it: - International - Local - Rationale of the study C. What still needs to be known D. What the current study attempts to add.  Introduction ◦ Should be to the point and concise. ◦Background and rationale: Scientific background with all known information related to the point of interest. ◦Statement of the problem: The research problem should be clearly identified, stating its prevalence whenever applicable. How the proposed study will help fill the gap of knowledge in the literature. ◦ Rationale for conducting the research: Why the research needs to be conducted in the selected population based on the currently available evidence. Explanation of potential benefits to patients/ health service, relevance to current policies and community priorities. It is strongly recommended that an up-to-date systematic review of relevant studies be summarized and cited in the protocol. Keep in mind: - A brief & to the point. - Don’t use any topics or titles in the introduction - Go from general to specific - Don’t use “I, We, Our or My research” …use the - Logical flow study - Literature must be within - Reference every last 5 years. statement - Better referring to - Don’t use different Egyptian & Arab studies. reference styles Research Question(s): ◦ To be answered by achieving the specific objectives Research Hypothesis: Aim Objectives what the study findings are What the study will actually expected to improve achieve Research Design and Methods A. Research design B. Description of study setting C. Population and sample: - target population (upon which the results will be generalized) - study population (from which the sample will be recruited) D. Description of the study sample in terms of: - Criteria of selection (inclusion and exclusion) E. Sample size (equation used and the referenced input(s) in the equation) F. Sampling technique G. Data collection tool(s): - Description of the tools in terms of: 1- Source and scientific basis (references) 2- Validity data (references) 3- Reliability data (references) Data management A. Computer program to be used B. Significance tests related to: 1. Study objectives/hypotheses 2. Study variables Ethical consideration - The proposal should include details of measures taken to guarantee full compliance with the principles of research ethics. - Issues to be clarified: A. Disclaimer and conflict of interest B. Human rights: 1. Informed consent 2. Confidentiality 3. Privacy 4. No actual or potential harm 5. Rights to refuse participation without giving reason and with no consequences 6. Rights to withdraw at any time without giving reason and with no consequences 7. Professional help C. Beneficence of the study. Time Plan - Timeline should be included for every objective. - How long will every step take to be done? - It should be written in table including a column for the objective and a column for the expected required time. Research Estimated Budget Should be written in the light of the materials and methods A. Itemized budget to include: 1. All items (available and needed): a. Equipment b. Supplies c. Manpower 2. Amount of each with justification 3. Price per unit B. Identify the needed items and their costs separately C. Include the budget even if the proposal is self-funded References List of references: This part helps the reader to find the references used. Any citations in the protocol must be presented in this list. The list should not contain references not used in the text. Try to use the most up-to-date references. Appendices Questionnaire Consent form  ‫عنوان البحث‬ ‫مقدم من‬ ‫اسم الطالب‬ ‫المشرفون‬ ‫اللقب‪.‬اإلسم‬ ‫الوظيفة الكلية الجامعة‬ ‫اللقب‪.‬اإلسم‬ ‫الوظيفة الكلية الجامعة‬ ‫اللقب‪.‬اإلسم‬ ‫الوظيفة الكلية الجامعة‬ ‫جامعة العريش‬ ‫‪2024/2025‬‬  ‫الملخص العربي‬ ‫العنوان‬ ‫المقدمة‪:‬‬ ‫مشكلة البحث‪ /‬أسئلة البحث‪ /‬أهمية الموضوع‪ /‬االفتراضيات – الدراسات السابقة‬ ‫الهدف من البحث‪:‬‬ ‫أسئلة البحث‪:‬‬ ‫خطة البحث ومنهجية الدراسة‪:‬‬ ‫التحليل اإلحصائي ‪:‬‬ ‫الجدول الزمني‪:‬‬  Guidelines for protocol preparation General Instructions Basic formatting Writing in General Set the word processor to 1.5 space Use complete sentences throughout the entire manuscript Do not use slang Use one inch margins on the left, right, top, and bottom of the page for Do not use contractions (like reviewer's comments “don’t”, “can’t”, “&”) Use normal paragraphs: the first line If you are doubtful about the is indented five characters spelling of a word, do not guess Use a 12 point Times New Roman Do not use too many abbreviations font Do not to use abbreviations in the Single space after sentence title (except well known ones) terminators (i.e., '.', '?', '!') When abbreviating any terms, spell them out the first time (in both the abstract and again in the body of the manuscript, if need be) Search on the internet Google scholar  PubMed PubMed is an excellent database for finding some articles on most health/ medicine topics. THANKS