Defining and Managing Protocol Deviation/Violation/Exception
Duration: 90 Minutes
Audits from either regulatory bodies and/or the sponsor companies are usual during the development of a clinical trial. The results of an audit affect both, the site and the sponsor of the clinical study. Good preparation for an audit starts from the beginning of the trial by identifying the risks of noncompliance during the trial. The first step in this process is understanding, correcting and preventing protocol deviations and violations.
Objectives of the Presentation
The objectives of the presentation are to talk in depth about:
Why Should you Attend
- ICH guidelines and Good Clinical Practice (GCP)
- Differences between protocol deviations/violations/exceptions
- Understanding compliance
- Most frequent audit findings
- Finding protocol deviations/violations
- Developing a CAPA plan
With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part to try to downsize the risk of noncompliance during the trial.
This presentation will help you to understand, correct and prevent potential protocol deviations/violations.
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
- Clinical trial sponsors study team
- CROs study team
- Study managers, Clinical team leads, CRAs
- Principal investigators, site managers and study coordinators
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Regulatory Compliance Associates and Managers