Research protocol
- 1. Research protocol Dr. Anil Bindu S Professor of Community Medicine Sree Gokulam Medical College Trivandrum
- 2. LEARNING OBJECTIVES What Why Parts
- 3. Research IDENTIFY A HEALTH PROBLEM FORMULATE RQ, OBJECTIVES PLAN ANALYSIS PREPARE DATA COLLECTION INSTRUMENTS SYSTEMATIC COLLECTION OF DATA, ANALYSIS INTERPRETATION OF DATA DRAW CONCLUSIONS FORMULATE RECOMMENDATIONS TO SOLVE A HEALTH PROBLEM/ ANSWER A QUESTION
- 4. Protocol A formal written record prepared before the actual research Blueprint for action
- 5. Why Research protocol Clarify Clarify the research question Compile Compile existing knowledge Hypothesis Formulate hypothesis, objectives Design Decide on study design Funding Apply for funding
- 6. Parts Introduction BACKGROUND RATIONALE RESEARCH QUESTION OBJECTIVES HYPOTHESIS MATERIALS AND METHODS Ethical considerations Timeline chart / study time frame Budget References (at least 5-10) Appendices
- 7. TITLE CONCISE AND DESCRIPTIVE INFORMATIVE AND CATCHY MUST REFLECT THE CENTRAL THEME AVOID NON INFORMATIVE WORDS LIKE “A STUDY OF……
- 9. Introduction Review of previous studies and critique Data gap / unclear areas Your hypothesis How it helps fill data gaps Why resources should be directed to your project
- 10. Research question Relation between two or more variables phrased as a question PICO
- 11. Research question Eg. Does brisk walking for at least 45 minutes in diabetic patients reduce the FBS as compared to those who do not?
- 12. Hypothesis Needs statistical testing Relationship between two or more variables phrased as a declarative statement
- 13. Hypothesis E.g. Std care plus a new drug will be superior to std care alone in reducing CVD mortality in patients with Coronary Artery Disease Purely descriptive question: do not require hypothesis
- 14. Hypothesis eg. The type 2 diabetic patients who do brisk walking for at least 45 minutes daily results in average reduction of 10mg% of FBS compared to those who do not
- 15. Objectives S pecific M easurable A ttainable R elevent T ime bound
- 16. OBJECTIVE Should summarize what you expect to achieve at the end of study Frame in scientific/ epidemiological language Make use of not more than one verb for each Estimate Determine Be clear about the type of question Descriptive (measures quantity) analytic/ experimental(tests hypothesis)
- 17. Objectives Primary & secondary objectives General and specific objectives
- 18. Why review of literature Work done by others on it or similar subject To understand the difficulties faced by other investigator, corrective steps and modifications Assist in identifying various variables in research protocol Assess feasibility of the study
- 19. REVIEW OF LITERATURE Relevant information from authentic, easily retrievable references
- 20. Review of literature : Scientific information gathering methods COMPUTER ASSISTED SEARCHES IN PUBMED JOURNALS BULLETINS OF ORGANIZATIONS LIKE WHO, CDC,ICMR BOOKS
- 22. Materials and methods .. Selection of study subjects: Inclusion/exclusion criteria operational definitions Sample size Sampling procedure Methodology of data collection, data collection tools Description of intervention (Who/what/when/how) Randomization procedure in RCT Study variables Dependent variables Independent variables
- 23. Sample size Parameters used to estimate sample size Provide References How you arrived at that number (Software/formula)
- 24. Data collection List the data that will be collected Specify how the data will be collected • Who/when/where How • Type of instrument to be used • Type of data collection methods
- 25. Plan for data analysis Data entry Software used Recoding
- 26. Plan for statistical analysis.. HOW WILL YOU DESCRIBE/SUMMARISE DATA SPECIFY THE TESTS WHICH MAY BE USED FOR ANALYSIS OF DATA
- 27. Project implementation plan Steps that will be used to ensure data quality at each stage
- 28. Ethical, administrative, regulatory considerations Institutional research committee Institutional ethics committee
- 29. Ethical considerations DECLARATION OF HELSINKI GOOD CLINICAL PRACTICE PROTECTION OF HUMAN VOLUNTEERS OBLIGATION OF CLINICAL INVESTIGATORS
- 30. Timeline chart Gantt chart Timeline chart
- 31. References All references should be cited Vancouver style
- 32. Appendices • Data collection forms • Questionnaires • Consent forms • Standard operating procedures • Adverse event management forms • Training framework for field staff
- 33. Research protocol for clinical research Systematically structured Scientific framework for clarifying the research question Proper and appropriate solution should be drawn by applying appropriate protocol
- 34. Protocol is the blueprint for doing the research Once approved by the IRC & IEC, Protocol cannot be changed Every deviation form the approved protocol should be intimated and get approval from IEC Once finalized it is easy to execute
- 35. Thank you