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Revision 2 of ICH E6 emphasizes a risk-based approach to managing clinical trials, especially those that rely heavily on electronic data systems and software. |
“As our clinical trials have continued to become more complicated with the increase in technology” — states Dr. Susan Leister, Director of Quality Assurance at Technical Resources International — “we strive to be more efficient. With this can come more risk.”
In Risk Management in Clinical Trials Dr. Leister explains the significance of the new focus on risk management and the benefits it can reap including:
- Directing the sponsor’s limited resources to higher risk areas, resulting in better overall quality
- Focusing more on prevention than on the traditional monitoring approach (process improvement vs. quality control)
- Reducing potential regulatory inspection findings
- Helping manage noncompliant sites/vendors/contractors
- Allowing more coverage of critical areas in the same amount of time
She offers recommendations for implementing new requirements, including:
- Implementing a quality management system that covers all stages of the trial process
- Identifying critical processes and key data
- Adopting principles of risk management — identification, evaluation, control, communication and review
- Meeting centralized monitoring requirements
- Validating electronic data processing systems
- How to address noncompliance that has the potential to significantly affect human subject protection or reliability of trial results
Order your copy of Risk Management in Clinical Trials: The New ICH E6 Focus for expert instruction on how to adapt to new risk management requirements.
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PDF Edition
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PDF Edition — $397
Who Will Benefit
- Medical Affairs Officers
- Director of Clinical Operations
- Regulatory Affairs Professionals
- Director of Publications
- Director of Clinical Trial Regulatory Management
- Clinical Trial Information Disclosure Directors
- Global Clinical Safety and Pharmacovigilance Officers
- Compliance Staff
- Clinical Quality Auditors
- Quality Assurance Personnel
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