A. COURSE DESCRIPTION 

The Clinical Research Methods Workshop is a workshop for writing a clinical research proposal. The workshop discusses the methods on clinical research. It covers the introduction to research processes, literature review and critical appraisal, study designs, sampling designs, randomizations, sample size determination and power, questionnaire design and data collection, data processing, data analysis using Epi Info software and ethical considerations.

This is a one-day intensive workshop. The participant will apply the concepts learned during the workshop on their research topics of interest and develop one research proposal. The proposal will be presented during the plenary sessions.

B. LEARNING OBJECTIVES

 In general, the workshop aims to apply the clinical research methods to develop a research proposal. Specifically, the learner should be able to:

1. Formulate a research problem;
2. Construct a conceptual framework of the research;
3. Review literature;
4. Formulate the research objectives
5. Select  a study design;
6. Choose a sampling design;
7. Compute sample size and power;
8. Choose the method of data collection;
9. Design questionnaire;
10. Describe the plan for data processing;
11. Describe the plan for data analysis;
12. Write-up the ethical considerations including authorship issues;
13. Write-up a clinical research proposal.
14. Appreciate and participate in the demo analysis using Epi Info

C. COURSE OUTLINE

1. The Research Process

2. Writing A Research Proposal
3. Related Literature Review and Critical Appraisal
4. Study Designs (Cross-Sectional Studies, Case-Control, Cohort and Randomized Controlled Clinical Trials)
5. Probability Sampling Designs and Randomizations (Simple Random Sampling, Systematic Sampling, Stratified Sampling, Cluster Sampling and Multi-stage Sampling)
6. Sample Size Determination (using Epi-Info ver6) and Power
7. Data Collection and Questionnaire Design

8. Data Processing
9. Data Analysis (Descriptive Statistics, Inferential Statistics and Data Analysis using Epi Info Ver. 3.5.1)
10. Ethical Considerations including Authorship Issues

D. COURSE MECHANICS

 The workshop consists of lecturettes (short lectures), small group discussions, plenary sessions, critiquing, and coaching/mentoring. The participants are expected to identify their research topic of interest before coming to the workshop.

Materials for the workshop will include the workshop kits containing copies of PowerPoint lectures, workshop syllabus/schedule, and course evaluation forms. The participant is encouraged to bring his/her own laptop for computer hands-on.

EPIINFO ver6 and ver3.5.1 statistical softwares will be introduced in the workshop. These should be downloaded by participants a week before the workshop.

The course content and delivery will be evaluated by the participants at the end of the workshop.

E. PROGRAM