What's New From NIAID, DMID, and the ICSSC
Fundamentals of International Clinical Research Workshop
The ICSSC returned to Bangkok, Thailand October 16-21, 2011 for this comprehensive workshop. We have held this training in Bangkok several times over the last few years. This year we hosted 37 participants from 14 countries.
This training is beneficial for principal investigators who design, conduct, and analyze research. In addition to principal investigators, study managers, data collectors, statisticians, trial clinicians, and data management personnel were exposed to an overview of the research process. The GCP discussions for this workshop are based on international guidelines of trial conduct that apply all over the world in general, and certainly to DMID-funded research.
Specific topics covered in the workshop included:
- Fundamentals of the research process
- Study design
- Protocol development
- Data management
- Statistical analysis
- Discussions on international research ethics
- Managing and implementing clinical studies
- Designing and managing adverse event reporting systems
- Specific information on Good Clinical Practices
- Practical information on NIH requirements for research