Study plan and Project management (BCBR) by Dr. Alisha Raj

Tried explaining about Study plan and Project management

1. Study plan and project management Presenter: Dr. Alisha Raj (JR3) Moderator: Dr. Shoebul Haque (SR) Peer support: Dr. Rashmi Chandra (JR3) Dept. of Pharmacology & Therapeutics King George’s Medical University, Lucknow, UP, India-226003 Email id: [email protected] 1 Dr. Alisha Raj 06-02-2025

2. Contents What is research ? Life cycle of research What is study plan ? Road map to study planning What is Project management ? Principles of Project management Summary References Dr. Alisha Raj 2 06-02-2025

3. Specific learning objectives- By the end of this teaching learning session, the audience will be able to: Enumerate steps of study planning Understand importance of study planning Understand what is project management Dr. Alisha Raj 3 06-02-2025

4. What is research ? Research is not merely gathering information, is a systematic process of collecting, analyzing and interpreting data in order to increase our understanding of a phenomenon about which we are interested or concerned Brent E, Leedy PD. Practical Research: Planning and Design. Teach Sociol . 1990 Apr;18(2):248. Dr. Alisha Raj 4 06-02-2025

5. LIFE CYCLE OF RESEARCH Pre-planning stage P lanning stage Post-p lanning stage 5 Dr. Alisha Raj 06-02-2025

6. Research problem The confusion at the beginning of the study: want to do a study, but not clear about the objectives have prepared a questionnaire, but not clear about exact information is needed will collect data, but not clear how to use that Dr. Alisha Raj 6 06-02-2025

7. Consequences are disastrous Data is difficult to analyze Even if analyzed, finding it difficult to interpret The interpretations are difficult to use in programs or for policy making Dr. Alisha Raj 7 06-02-2025

8. What is study plan ? A study plan is an essential blueprint that outlines all the elements of a research project E nsures systematic data collection and analysis Dr. Alisha Raj 8 06-02-2025

9. Example “ A Randomized Controlled Trial Comparing a 12-Week Cognitive Behavioural Therapy Program Versus Antidepressant Medication in Reducing Depressive Symptoms Among Adults with Major Depressive Disorder" P : Patients diagnosed with Major Depressive Disorder (MDD) I : Cognitive Behavioral Therapy (CBT) C : Antidepressant medication (e.g., SSRIs ) O: Reduction in depressive symptoms T: 12-Week – Defines the duration Dr. Alisha Raj 9 06-02-2025

10. A road map to study planning 10 Dr. Alisha Raj 06-02-2025

11. 1. Formulate appropriate objectives for the study Framing at the planning stage is critical Cannot be added during study implementation or analysis stage Objectives: minimum clear achievable 11 Dr. Alisha Raj 06-02-2025

12. Dr. Alisha Raj 12 MEASUREABLE Quantifiable ACHIEVABLE Realistic and feasible RELEVANT Meaning and linked to research goals TIME-BOUND Defined time frame SPECIFIC Clearly defined and focused 06-02-2025

13. Example Specific: clearly defines what is being compared (CBT vs. antidepressant medication) and in which population (MDD patients) Measurable: reduction in depressive symptoms can be measured using the Hamilton Depression Rating Scale (HDRS) Achievable: use of well-established interventions make this realistic Relevant: effectiveness of these treatments is directly relevant to improving clinical decision-making in mental health care Time-bound: the timeline 12 weeks is specified Dr. Alisha Raj 13 06-02-2025

14. Dr. Alisha Raj 14 Primary objective Secondary objective The main goal of the study Additional research questions that provide supportive or exploratory findings Determines the primary research question Safety, tolerability, subgroup analysis or long-term effects Maintain clarity and focus Broader implications of the primary objective 06-02-2025

15. Example Primary Objective: To compare the effectiveness of Cognitive Behavioral Therapy (CBT) versus antidepressant medication in reducing the severity of depressive symptoms in patients with Major Depressive Disorder (MDD) over a 12-week period. Secondary Objectives: To evaluate the impact of CBT and antidepressant medication on quality of life using validated scales To assess the adherence and acceptability of CBT versus antidepressant medication among patients with MDD Dr. Alisha Raj 15 06-02-2025

16. Did investigator assign exposure ? Observational study Experimental study Comparison group ? Random allocation ? Non-randomised controlled trial Randomised controlled trial Analytical study Descriptive study 2. Choose the right design to determine key indicators yes yes no no yes no Dr. Alisha Raj 16 06-02-2025

17. Cohort study Case control study Cross-sectional study Analytical study Direction ? Exposure to outcome Outcome to exposure Exposure & outcome at the same time Dr. Alisha Raj 17 06-02-2025

18. Decide the indicators that the study will generate Dr. Alisha Raj 18 Rates Ratio Proportions 3.Identify parameters needed for the key indicators Identification of information needed to calculate the indicator 06-02-2025

19. Identify the information elements that will be needed to calculate the indicators Dr. Alisha Raj 19 Numerators Denominators 06-02-2025

20. L ist information elements that will be used to calculate indicators Dr. Alisha Raj 20 Outcome variables Covariate 06-02-2025

21. Principles to be followed while collecting the information elements Use the variables that will best reflect the information element Adopt standardized: methods and criteria case definitions and laboratory criteria Decide the most accurate way of collecting information on various elements - Observation, interview or laboratory methods 21 Dr. Alisha Raj 06-02-2025

22. 4. Prepare the analysis outline It is structured plan for how the collected data will be analyzed to answer the research question It helps ensure that the study is methodologically sound, organized and interpretable 22 Dr. Alisha Raj 06-02-2025

23. Advantages of making an analysis plan F ocus on the objectives of the study Start by preparing dummy tables A void comparisons for which the study has not been designed Makes sure that only data that can be analyzed is collected Save time Dr. Alisha Raj 23 06-02-2025

24. 5. Estimate sample size Ensures that the study has enough participants to detect a true effect while avoiding unnecessary resource use Findings can be generalizable Ensures accuracy Prevents statistical errors Optimizes resources 24 Dr. Alisha Raj 06-02-2025

25. What is Project management ? Project Management may be described as a set of activities which enables successful implementation of a project Dr. Alisha Raj 25 06-02-2025

26. Principles of project management To ensure defined objectives are met Within the defines timeframe Within budget At the expected quality standards End result should provide directions for future implications 26 Dr. Alisha Raj 06-02-2025

27. Relationship between the research plan and the principles of project management Dr. Alisha Raj 27 06-02-2025

28. Dr. Alisha Raj 28 Human resource management Study staff should be carefully chosen and appropriately trained Time management Scheduling various activities and ensuring that done in time GANTT CHART- duration, timeline and sequence of activities and milestones of a research Budgeting Plan in advance that at what stage what kind of money will be released Quality management Done at all levels and is critical Data management If managed timely, any possible change or corrections can be done without facing any issue at the end Communication Should be good bonding and communication among members Monitoring the progress and targets Supervision is done to check what is happening in the study Essential points in study/project management 06-02-2025

29. Common reasons for study failures: P oorly defined research question and objectives Unrealistic vague timescales - too short or too long Inappropriate and incompetent staff: lack of direction, motivation and training Inadequate monitoring failure to respond to contingent situations and carry out mid-course corrections 29 Dr. Alisha Raj 06-02-2025

30. Summary A well-structured study plan helps define the research objectives, methodology and timeline Project management ensures that the study progresses efficiently, overcoming challenges and staying within scope SMART- Specific, Measurable, Achievable, Relevant and Time-bound Principles of project management- Within the defines timeframe Within budget At the expected quality standards Dr. Alisha Raj 30 06-02-2025

31. References Indian Council of Medical Research – National Institute of Epidemiology. Basic Course in Biomedical Research Course Material. Chennai: ICMR-NIE; . Available from: https://nptel.ac.in/courses/127/106/127106134 Mehta T. Analytical study designs: Basic Course in Biomedical Research Handbook. 1st ed. Chennai: ICMR-NIE; 2021. p. 231-247. Brent E, Leedy PD. Practical Research: Planning and Design. Teach Sociol . 1990 Apr;18(2):248. Weber RJ, Cobaugh DJ. Developing and executing an effective research plan. Am J Health Syst Pharm. 2008 Nov 1;65(21):2058–65. Dr. Alisha Raj 31 06-02-2025

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33. Questions What is life cycle of research ? What are the five elements of good research question ? Which criteria is to be followed while formulating objective? Define primary and secondary objectives? What are the principles of project management? Dr. Alisha Raj 33 06-02-2025