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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.

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.

ITHS provides auditing and quality assurance review services upon request on a fee for service basis. For more information or to request a price quote, please contact us.

How to Prepare for a Review

How to prepare for a monitoring visit

To get ready for a monitoring visit, Food and Drug Administration inspection, or audit:

  • Gather your regulatory documents to provide to the reviewer. The Regulatory Documents Checklist describes and provides the regulatory requirements for commonly requested regulatory documents.
  • Prepare your participant records so the reviewer can verify that study procedures are documented and comply with protocol requirements. The Participant Records Checklist details the questions necessary to confirm compliance and provides the regulatory basis for this assessment.

205 kBRegulatory Documents Checklist208 kBParticipant Records Checklist

A typical review confirms the following:

  • Informed consent was obtained prior to conducting any study procedures.
  • The participant met eligibility requirements.
  • All study procedures occurred within the specified timeframe as outlined in the protocol.
  • If not, a protocol deviation/violation was reported as required, along with a description of preventive measures to ensure the deviation/violation will not occur in the future.
  • Drug/product was dispensed, dosed, or administered correctly and within the approved timeframe.
  • Individual participant adverse events are documented and reported as required.

You can review these checklists to get an idea of what to include, and even do a self-audit. If you need additional regulatory logs or templates, regulatory binder forms are posted to the ITHS forms page.

Common Review Findings

Common Review Findings

Based on reviews completed in the past, the most common findings are:

  • Incomplete, undocumented, or missing informed consent and/or assent
  • Incomplete or missing data collection forms
  • Missing source documents
  • Revisions made to study records without initialing, dating, and/or providing rationale for the change
  • Unreported adverse events
  • Unreported protocol deviations and violations
  • Unreported unanticipated problems
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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.