Course

Unit 1

General Research Methodology 06 hrs

· Introduction to Research Methodology:

• Definition and purpose of research – 1hr
• Types of research and study design – 1 hr
• Review of Literature – 1 hr
• Steps in the research process – 1 hr
• Introduction to research proposal and its components – 1 hr
• Trends, Challenges and Bias in Research – 1 hr

Unit 2

Biostatistics: 06 hrs

• Introduction: – 1 hr
  • Definition and scope of biostatistics
  • Role of statistics in biological and health sciences

· Probability Theory – 1 hr

• Basic probability concepts and rules
• Probability distributions: normal, binomial, Poisson
• Concepts of random variables and expected value

· Statistical Inference – 2hrs

• Sampling methods and techniques, sample size determination and factors affecting sample size.
• Estimation: Point estimates and confidence intervals
• Hypothesis testing: null and alternative hypotheses, Type I and Type II errors

· Probability testing – 2hrs

• Testing of significance and p-
• Parametric tests: t-tests (independent samples, paired samples) Analysis of variance (ANOVA): one-way and two-way
• Non-parametric tests: Chi-square test, Mann-Whitney U test, Kruskal-Wallis test

Unit 3

Medical Research and Research Ethics 06 hrs

• Core Ethical Principles (2 hrs)
  • Introduction to Medical Research Ethics
  • Autonomy: Respecting patient’s self-determination and informed
  • Beneficence: Obligation to act in the best interest of the
  • Non-maleficence: Duty to avoid causing

· Criticisms and Developments in Medical Ethics (2 hrs)

• Criticisms of Medical Ethics: Limitations and evolving
• Cultural Concerns: How cultural differences impact ethical decision-
• Truth Telling: Balancing honesty with patient
• Declaration of Helsinki: History and Ethical principles in medical research involving human subjects.

· Practical Aspects and Governance (2 hrs)

• Importance of Communication: Effective communication strategies in medical
• Control Resolution and Guidelines: Procedures for handling ethical
• Ethics Committees: Role and functioning in research and clinical
• Online Business Practices: Ethical concerns in digital health and

Unit 4

CCSEA guidelines for laboratory animal facility 06 hrs

• Introduction to Animal Maintenance- 2hrs
  • The importance of CCSEA
  • Ethical Considerations and Welfare
  • Housing and Environmental Enrichment

• Nutrition and Feeding
• Record Keeping and Documentation

• Compound administration – 1hr
• Sample collection, anaesthesia and Euthanasia – 2hrs
• Carcass Disposal and Safety Protocols – 1hr

Unit 5

DATA INTEGRITY AND DOCUMENTATION 06 hrs

• Importance of Data Integrity and Documentation – 1 hr
• Good Documentation Practice including paper and electronic records – 1 hr
• Data Integrity Guidelines -2 hr
• Elements of QMS (Quality Management System) for Data Integrity – 1 hr
• Managing and Preventing Data Integrity Breaches – 1hr

Biostatistics and research methodology in pharmacy are essential subjects that provide students with the abilities to perform scientific research efficiently. The process starts by instructing individuals on the basic principles of research protocol drafting, a crucial skill for effectively organizing and carrying out research endeavors in a systematic manner. Students acquire the skills to develop research inquiries, establish goals, and create research plans that adhere to ethical and scientific criteria. Students receive training in literature reviewing, which enhances their ability to critically examine existing research, identify areas that need more investigation, and contribute to the advancement of knowledge in the pharmaceutical profession.

Moreover, the course includes essential statistical principles like determining sample size and conducting hypothesis testing, which are crucial for guaranteeing the accuracy and dependability of research results. The program also highlights the significance of truthful reporting following data integrity guidelines, documentation, data presentation and report writing. In summary, this topic equips pharmacy students with the necessary skills to actively participate in evidence-based practice, contribute to scientific progress, and make well-informed judgments in their professional endeavours.

COURSE LEARNING OUTCOMES

Upon successful completion of the course, the student shall be able to;

KNOWLEDGE

K1 Explain the components and significance of a research protocol,

K2 Concise research questions and objectives that address gaps in current pharmaceutical knowledge

K3 Comprehend various statistical techniques and their applications in analyzing research data

K4 Outline key elements of effective scientific report writing and data integrity guidelines.

K5 Justify sample sizes for various study designs

K6 Integrate core ethical principles in the design and conduct of research

SKILL

S1 Develop research protocols adhering to scientific and ethical standards.

S2 Design research plans to address ethical and scientific requirements.

S3 Contribute to evidence-based practices in pharmacy through informed decisions.

S4 Interpret hypothesis tests to evaluate research data and draw valid conclusions

S5 Demonstrate proficiency in regular documentation, data presentation and report writing

S6 Integrate research findings into clinical and professional practice

ATTITUDE

A1 Demonstrate ethical responsibility in all aspects of research practices.

A2 Embrace collaboration and teamwork in multidisciplinary research environments.

A3 Exhibit critical thinking in evaluating and interpreting scientific literature.

A4 Promote open-mindedness towards diverse perspectives in scientific research.

A5 Cultivate curiosity for continuous learning and scientific exploration

A6 Uphold data integrity and good documentation practices

TEXTBOOKS:

1. K R Sundaram, S N Dwivedi and V Sreenivas; Medical Statistics: Principles and Practice, 2nd Edition, Wolters Kluwer | Lippincott Williams and Wilkins India; 2014
2. Sanford Bolton; Pharmaceutical statistics- Practical and clinical applications, 5^th Edition, Marcel Dekker Inc. New York: 2009
3. BayyaSubba Rao; Pharmaceutical Research Methodology and Biostatistics: Theory and Practice, PharmaMed Press / BSP Books India: 2020
4. Kothari,C.R and Gaurav Garg,Research: Methods and Techniques, 4^th edition, New age international publishers, New Delhi

5. Rao, Sundar S.S and Richard J: Introduction to Biostatistics,5^thedition, PHIpublishers,New Delhi
6. Jann Hau, Steven J. Schapiro. Handbook of Laboratory Animal Science, Essential Principles and Practices. 4th Edition 2021, CRC Press, Boca Raton, Florida

REFERENCE BOOKS:

1. C. Gupta, Fundamentals of Statistics: 7th Edition, Himalaya Publishing House: 2017
2. Douglas C. Montgomery, Design and Analysis of Experiments 10^th Edition, Wiley India: 2019

JOURNALS

Statistics in Medicine Online library, Wiley Online

Medical hypotheses – Science Direct

The international journal of biostatistics- De Gruyter Brill

Laboratory Animals – SAJE Journals

ASSIGNMENTS

1. Impact of Study Design on Research Outcomes
2. Systematic Review of Literature on a Specific Medical Condition
3. Ethical Dilemmas in Medical Research: Case Studies and Solutions
4. Probability Distributions in Health Sciences: Applications and Implications
5. Challenges and Bias in Contemporary Medical Research
6. Ethics Committees: Role, Functioning, and Impact on Research Quality
7. CCSEA Guidelines for Laboratory Animal Facilities
8. Innovative Approaches to Animal Welfare in Research Laboratories