Clinical Compliance 2011 - Identifying and managing unplanned protocol excursions and adhering to GCP

Why Should You Attend:

During the implementation and conduct of study protocols, investigators often fail to adhere to many elements of GCP regulations. Such violations can potentially impact patient safety and data integrity as well as increase risks to the subject population. Despite extensive and costly monitoring by sponsoring companies, study audits continue to identify protocol deviations and violations resulting in numerous FDA 483 citations.

This presentation will help participants identify key risk elements of protocol non-compliance, understand the responsibilities of the clinical research site and use effective strategies to successfully prevent regulatory and IRB actions.

Areas Covered in the Seminar:

Designing scientifically sound protocols.
Understanding applicable regulations and guidance.
Core protocol team responsibilities.
Ethical research oversight involving human subjects.
Challenges associated with successful protocol implementation.
Frequent audit findings.
Practical strategies to minimize and manage protocol deviations.
Key communication issues of investigational team with IRBs, FDA auditors and sponsors.

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