“Clinical Research Methodology”
     วันที่ 1

1. Protocol design/ research planning
2. Select an Appropriate Study Design
3. Statistical analysis for non-statisticians
   - Basic Statistical Concepts (Summarizing Data / Probability and Statistics / Estimation / Hypothesis Testing)
   - Sample size/ power
   - Statistical Analysis Plan
   - How study data are examined statistically

   “Advanced Good Clinical Practice (GCP) in Clinical Research”
     วันที่ 2

1. Development of ICH GCP& Overview of Clinical Research in advance aspects
   - Differences between clinical practice and clinical research
   - Differences between US FDA GCP and ICH GCP
   - Regulatory update affecting the clinical trial process
2. Responsibilities of the Ethics Committee in Human Research and the processing
3. Responsibilities of the sponsor
4. Responsibilities of the investigator
5. Informed Consent (Advanced issues)
   - Important points to be considered by EC (EC perspective)
   - CAB/volunteer point of view toward Informed Consent
   - Informed Consent Process: scenarios group discussion
6. Essential Documents in Regulatory File& Group Discussion

   “Advanced Good Clinical Practice (GCP) in Clinical Research” (continue)
     วันที่ 3

1. Recapitulation
2. Safety reporting in special situations
   - Understand how to classify and assess an AE/SAE
   - Describe AE and SAE reporting and documentation
   - Round Table Exercise and Discussion: Safety Reporting
3. . Preparation for GCP/FDA Audit
   - Audit activities and responsibilities of investigators
   - Most Common audit findings and their Importance
4. Fraud and Misconduct in Clinical Research
   - What makes FDA suspicious of a clinical trial site
   - Detecting and preventing
5. Data Management Systems (DMS):
   - DMS design and technology
   - Electronic records/ signatures (21 CFR Part 11) and data quality
   - Why FDA part 11 is still the focus today
   - Part 11 activities in clinical research
   - Quality control and assurance
   - Electronic data capture (EDC) and data security
   - New approach in EDC
   - Back up system, archive data
   - EDC application
6. Summary – Q&A
7. Closing Remarks and Certificates