INTRODUCTION
This course will provide a foundation in investigator-initiated clinical research. The course is formulated to train participants on how to effectively conduct clinical research. The course covers the broad spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects and building a budget. Techniques of literature searching and critical review of the scientific literature will serve as a skills foundation for evaluating the current state of research questions.
PROGRAM OBJECTIVES
- Understanding the scope of clinical research and clinical trials
- Identifying clinical research questions and appropriate methodology
- Understanding the most important ethical issues in clinical research
- Understanding the Institutional Review Board process
- Identifying methods for seeking funding sources
- Improving grant writing skills
- Understanding the special considerations involved in conducting international research
WHO SHOULD ATTEND?
- Clinical researchers who are planning or running clinical trials
- Medical staff,
- Clinical research coordinators,
- Data managers,
- Research nurses or research co-assistants,
- Those who wish to build their knowledge of clinical trial methodologies.
PROGRAM OUTLINE
- Asking a research question & setting up a hypothesis
- The role and importance of the scientific method in health care
- The principles of randomised controlled trials.
- Research and Regulatory Issues
- Design of epidemiologic studies
- Issues in randomization
- Measures
- Participant selection
- Overview of hypothesis testing
- Qualitative and quantitative research design
- Secondary data/meta analysis
- Sample size and power
- Conceptual approach to survival analysis
- Study development
- Designing and testing questionnaires
- Efficient clinical trials
- Research with vulnerable participants
- Ethical principles in clinical research
- Preparations & planning for clinical trials
- Essential documentation in clinical research & regulatory submissions
- Clinical trials project planning & management
- Information resources for clinical research
- Quality of life
- Scientific conduct
- NIH peer review process
- Clinical monitoring essentials
- Compliance, auditing & quality control in clinical research
- Data management in clinical trials
- Investigating the collection, analysis, and interpretation of data
- The dissemination of health research.
- Quality control in clinical trials
- Clinical research from the patient's perspective
- Design of case report forms
- Prototype and protocol mechanics
- Legal issues in clinical research
- Evaluation of a protocol budget
- Human genome project and clinical research
- Product development: moving from the bench to the clinic
- FDA product regulation
- Inclusion of women and minorities in clinical trials
- Evaluation of alternative and complementary therapies
- Health disparities research
- Community-based participatory research
Permintaan Brosur penawaran Training
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