Course Title: Research Methods and Skills Course Code: CLS 291 Program: Clinical Laboratory Sciences Department: Clinical Laboratory Sciences College: College of Applied Medical Sciences Institution: Taibah University Version: 1 Last Revision Date: N/A A. General information about the course: 1. Course Identification 1. Credit hours: 2 CH 1 T + 1 P 2. Course type A. ?University ? College ? Department ?Track ?Others B. ? Required ?Elective 3. Level/year at which this course is offered: Level: 3 Year: 2 4. Course general Description: Students in this course will be introduced to the basics of clinical research methodology, including study designs, sampling methods, sample size calculation, and ethical concerns in clinical research. 5. Pre-requirements for this course (if any): None 6. Co-requisites for this course (if any): None 7. Course Main Objective(s): • To explain the basics of clinical research methodology. • To highlight the type, use, strengths, and limitations of each study design. • To describe how valid and reliable data can be obtained. • To cover how to write research question and hypothesis. 2. Teaching mode (mark all that apply) No Mode of Instruction Contact Hours Percentage 1 Traditional classroom 45 100% 2 E-learning 0 0 3 Hybrid • Traditional classroom • E-learning 0 0 4 Distance learning 0 0 3. Contact Hours(based on the academic semester) No Activity Contact Hours 56. Lectures 15 57. Laboratory/Studio 30 58. Field 0 59. Tutorial 0 60. Others (specify) 0 Total 45 B. Course Learning Outcomes (CLOs), Teaching Strategies and Assessment Methods Code Course Learning Outcomes Code of PLOs aligned with program Teaching Strategies Assessment Methods 1.0 Knowledge and understanding 1.1 Explain the basics of clinical research methodology. K1 Lectures, group discussion MCQ, short and long essay questions 1.2 Highlight the type, use, strengths, and limitations of each study design. K2 Lectures, group discussion, problem-based learning MCQ, short and long essay questions 1.3 Describe the process of obtaining valid and reliable data in clinical research. K3 Lectures, group discussion, problem-based learning MCQ, short and long essay questions 2.0 Skills 2.1 Write research question, hypothesis, and aim. S1 Lectures, group discussion, elearning, problembased learning Short essay questions 2.2 Discuss the use of specific study design to answer research question of interest. S2 Lectures, group discussion, problem-based learning Short and long essay questions 3.0 Values, autonomy, and responsibility 3.1 Select the appropriate research design and tools to answer research question through adherence to the ethical standards of research. V1 Lectures, group discussion, elearning, problembased learning MCQ, short and long essay questions, ethical certificate C. Course Content No List of Topics Contact Hours 1. Course Overview and Introduction to the Course 1 2. Conceiving the Research Question and Developing the Study Plan 1 3. Basic Steps in the Research Process 1 4. Identifying Knowledge Gaps in Medical Research 1 5. Planning the Measurements: Precision, Accuracy, and Validity 1 6. Qualitative and Quantitative Research 1 7. Principles of Sample Size Calculation 1 8. Addressing Ethical Issues in Clinical Research 1 9. Designing Questionnaires and Online Surveys 1 10. Designing Cross-Sectional Studies 1 11. Designing Cohort Studies 1 12. Designing Case-Control Studies 1 13. Designing Randomized Blinded Trials 1 14. Alternate Interventional Study Design 1 15. Writing Research Proposal 1 Practical Sessions 1. Library session • Introduction to library services • How to create an account, use the database to download articles 2 2. Writing Research Question and Hypothesis 2 3. Sampling Techniques 2 4. Referencing (manual and using reference management software) 2 5. Designing Questionnaires and Online Surveys 2 6. Reading Scientific Papers 2 7. Qualitative and Quantitative Research 2 8. Addressing Ethical Issues in Clinical Research 2 9. Biological Sample Collection and Handling 2 10. Basic Laboratory Techniques and Instrumentation 2 11. Tissue Culture Techniques 2 12. In vitro, ex vivo, in vivo Studies in Medical Research 2 13. Positive and Negative Controls in Experimental Design 2 14. Presenting Research Findings 2 15. Writing Research Proposal 2 Total 45 D. Students Assessment Activities No Assessment Activities * Assessment timing (in week no) Percentage of Total Assessment Score 33. Continuous assessment: Quizzes Ongoing 5% 34. Lab reports Week 14 5% 35. Assignment Week 12 5% 36. Written test: Midterm exam Week 8-9 15% 5. Written test: Practical exam Week 15-16 30% 6. Written test: Final theoretical exam Week 17-18 40% *Assessment Activities (i.e., Written test, oral test, oral presentation, group project, essay, etc.). E. Learning Resources and Facilities 1. References and Learning Resources Essential References • Browner W, Newman T, Cummings S et al. (2022). Designing Clinical Research. 5th ed. Wolters Kluwer. Supportive References Electronic Materials • Reference Management Software (Mendeley, Zotero RefWorks, EndNote) Other Learning Materials • Saudi Digital Library 2. Required Facilities and equipment Items Resources facilities (Classrooms, laboratories, exhibition rooms, simulation rooms, etc.) Classrooms, Computer Lab Technology equipment (projector, smart board, software) Projector, Reference Management Software (Mendeley, Zotero EndNote, RefWorks) Other equipment (depending on the nature of the specialty) F. Assessment of Course Quality Assessment Areas/Issues Assessor Assessment Methods Effectiveness of teaching Instructor ü Direct Method (Rubrics) ü Indirect Method (Questionnaire on the course by the end of the semester) Assessment Areas/Issues Assessor Assessment Methods Effectiveness of Students' assessment Head of the department Student achievement is verified by the head of the department. Quality of Learning resources Instructor Student ü Course Report. ü Course Evaluation Survey (CES) Achievement of Course Learning Outcomes Instructor Students ü Direct Method (Rubrics) ü Indirect Method (Questionnaire on the course by the end of the semester) ü Course Evaluation Survey (CES) Effectiveness of Assessment Results Instructor ü Course Report ü Grade Report Analysis ü Course Evaluation Survey (Indirect) Assessors(Students, Faculty, Program Leaders, Peer Reviewer, Others (specify) Assessment Methods(Direct, Indirect)