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Quality Assurance and Safety Office

The Quality Assurance and Safety Office (QASO) at the CTSR understands the importance of maintaining the quality and integrity of records and data throughout the life-cycle of a clinical trial. The QASO works in cooperation with research clinical, regulatory and data staff to assure continual assessment and improvement of clinical trial processes through internal auditing leading to performance metric trending that highlights areas of process breakdown. These analyses provide opportunities for process enhancement and further staff training.

To assure consistency of clinical trial processes, various key indicators are monitored to inform the quality management plan. The key quality indicators monitored throughout the conduct of a clinical trial include, but are not limited to, the following:

  • Informed consent process
  • Eligibility criteria
  • Serious Adverse Event (SAE) and Adverse Event (AE) reporting
  • Timely scheduled procedures and tests
  • Thorough clinical documentation

Orientation and Training
The QASO is responsible for the orientation and training of all research staff to assure standardized practice across all research job roles and responsibilities. Consistent educational opportunities are offered through monthly staff meetings, weekly disease-specific meetings and instructional in-services to assure staff development in clinical oncology and relevant operational issues.

Research Staff training includes:

  • Human SubjectsProtection Training (CITI)
  • Good Clinical Practice (CITI)
  • Review of CTSR Standard Operating Procedures (SOPs)
  • Investigator Training
  • Orientation plan tailored to the education and experience of individual staff

For more information or assistance, contact:

Lisa R. Gaynes
Senior Director of Clinical Research Administration
(615) 875-9376