Protocol for an experimental study design BSRM.pptx

An experimental study design

1. Discuss the protocol for an experimental study design Presented by, Aliujjaman 8 th sem ,B pharm HCOP Biostatistics and research methodology 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 ‹#›

2. Introduction: An experimental study design is a structured method of research in which the investigator manipulates one or more independent variables to observe the effect on a dependent variable, while controlling for extraneous factors. This design aims to establish cause-and-effect relationships between variables. This design is widely used in fields such as medicine, psychology, education, and the social sciences because of its ability to establish causality rather than mere association. 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 2

3. The protocol: Aim : To preventing bias and to reduce the source of error of the study. Protocol is a research document that specifies the structure of a research plan for a clinical trial. Benefit of protocol : Permit the research to plan and review the phases the project . Act as a guide through out the research . Estimate the time and budget . Ensure that data obtain is acceptable for publication. 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 3

4. Content of protocol: The commonly followed research protocol along with its elements is written according to format. 1)Project title : Title must be precise and concise (12–15 words). Include administrative details: Protocol ID  Name and address of regulatory sponsor Version number Statement of purpose  9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 4

5. 2 ). Protocol Summary It’s Must be concise and summarize all elements of the protocol.  Typically written after completing the full protocol. 3). Introduction Study Question: Protocol should start with a clear and precise formulation of the research question. Must consider: Relevance of the question Feasibility of conducting the study 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 5

6. (b) Rationale : Explain why the research is neededand its relevance. Should be a clear statement of the research question Must be simple, specific, and stated in advance Include: Primary objective ,Secondary objectives (if any) 4).Design and Methods Study Design : Here Clearly mention the type of study like Cross-sectional, Cohort ,Case-control ,Experimental/Intervention study. Protocol needs to explain why a particular study design has been chosen in preference to others. 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 6

7. (b) Study Population : Define who the study will involve and Mention to whom the results will be applicable. (c) Sample Size : The protocol should Provide information and justification for sample size. The basic for selected sample size should be explained in the methodology section of the protocol. (d) Study subject :This section should explain how many subjects will be selected , where and why . 5)Ethical consideration : ethical concideration are applicable for all types of health research . The ethical issues involved in the study like benefits of the study procedures , hazards,responsibility of injury voluntary consent,etc.must be specified. 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 7

8. 6) Strengths and limitations : It is important to include the possible criticisms of proposed design and methods. It must provide reasons why investigator thinks the limitations imposed by his choices are not the serious ones. Similarly, it is useful to identify important aspects of the protocol that are particularly strong and worthy of financial support 7)Budget summery : In this section , a brief outline of the budget requirement showing head-wise expenditure such as man power ,logistics ,transportation , etc. 8)Reference :A list of various references quoted while formulating protocol may be listed in a sequential manner. The reference should follow uniform format . 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 8

9. THANK YOU 9/16/2025 Dept. of Pharmaceutics, HCOP, Bangalore, Karnataka-562123 9