The QA office is a resource that assists investigators at the School of Medicine, including Yale Cancer Center, in conducting high-quality compliant clinical research. QA Specialists are available to consult with investigators on quality-related issues, such as Federal Regulations, Good Clinical Practice or other protocol compliance issues, upon request. In addition, QA Specialists review trials using risk-based stratification, providing feedback on compliance and opportunities for systems improvements.
Our QA Specialists are available to provide their expertise to confirm your study is conducted according to GCP guidelines and all other applicable regulations and provide feedback and suggestions.
Some of the various services provided by the QA Specialists are listed below:
- Conduct internal audits using risk-based stratification methods
- Consult with investigators who have been notified that they will undergo an external audit to correct any deficiencies
- Review external audits and monitoring reports
- Consult with investigators and research staff regarding compliance with Good Clinical Practices
- Identify areas for education or system improvement
- Provide training and educational instruction to augment the education provided institutionally
For research Guidance, Tools and Templates please click here.
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