Identifying and managing unplanned protocol excursions and adhering to GCP - Webinar By ComplianceOn (Clinical)
Venue: Online Event
|Event Date/Time: Mar 16, 2011||End Date/Time: Mar 16, 2011|
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.
Who Will Benefit:
This webinar will provide valuable information and provide a familiarity with practices to pharmaceutical, biotechnology and study site personnel, including:
Sponsor and study site professionals involved in trial planning and management
Administrative study managers, clinical team leaders and CRAs
Principal investigators, site managers and study coordinators
Regulatory compliance associates
Note: Use this promocode(117660) for 10% discount.