How strong is your knowledge of GCP? 2011
18 October, 2011
Palm Beach FL , USA
This 90-minute GCP webinar will present the official GCP text instead of interpretations of the GCP guidelines. It will analyze clinical trial conduct via the GCP handbook itself and therby familiarize you with the structure nd content of actual GCP guidelines.
When conducting a Clinical Trial, GCP is the only recognized code of practice and needs to be followed meticulously. Yet, most presentations on GCP rely more on the presenters' experiences and interpretations of the GCP guidelines than on the actual, official text.
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.
When conducting a Clinical Trial, GCP is the only recognized code of practice and needs to be followed meticulously. Yet, most presentations on GCP rely more on the presenters' experiences and interpretations of the GCP guidelines than on the actual, official text.
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.
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How strong is your knowledge of GCP? 18 October, 2011
