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Auditing and Quality Assurance Review Services

Auditing and Quality Assurance Review Services

ITHS offers auditing and quality assurance review services for departments and investigators who are interested in one-time data checks. The goal of these programs is to ensure your study is run efficiently and effectively to produce high-quality data.

How We Help

ITHS Auditing & Quality Assurance Review Services helps departments and individual investigators to:

  • Prepare for inspections or respond to concerns by industry sponsors and oversight agencies, such as the Food and Drug Administration (FDA) and the Institutional Review Board (IRB)
  • Evaluate study status during staffing transitions
  • Assess current processes to ensure data integrity
  • Make organizational improvements to streamline workflow

Reviews are customized to meet your regulatory or operational needs. For example, if you have undergone an FDA inspection and had findings, ITHS can assist you in addressing FDA’s concerns with valid, thorough solutions that take into consideration the resources available to you.

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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.