How strong is your knowledge of GCP? A presentation on official GCP guidelines for compliant investi (Clinical Training)
Venue: Online Event
|Event Date/Time: Oct 18, 2011||End Date/Time: Oct 18, 2011|
The version of the ICH GCP guideline that will be analyzed is ICH/135/95, July 2002, from the European Medicines Agency NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95, July 2002.
Areas Covered in the Seminar:
- Sponsor responsibilities & tasks when running clinical trials (incl. CRA responsibilities).
- Investigator responsibilities & tasks when running clinical trials.
- Exploring the structure of the GCP handbook.
- Importance of Good Clinical Practice.
- Essential documents in Clinical trials.
- Definition of Adverse and Serious adverse events.
- ICH guidelines on the Informed consent process.
- How inspectors use the handbook.
- Definition of ranking of audit findings: minor-major-critical.