World Conference Calendar

34363 Conferences

Defining and Managing Protocol Deviation/Violation/Exception

Added by Referral on 2010-07-15

Conference Dates:

Start Date Start Date: 2010-08-10
Last Date Last Day: 2010-08-10

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF).

Areas Covered in the Seminar:

- How to define and manage Protocol Deviation/Violation/Exception.
- Proactive approaches to predict and prevent clinical trial protocol violations.
- Industry and FDA perspectives on Protocol Deviation/Violation/Exception.
- Discuss the current lack of unified definition for protocol deviation/violation/ exception.
- Define the term “Protocol Not Followed” (PNF).
- Explain the guidelines for the implementation of PNF to include capturing, reporting, and documentation.
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs.

For More Details: ecommerce/control/trainingFocus/~product _id=701670?channel=worldconf
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