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The Post As of July 2022: Monitoring & Quality Assurance Standards for Clinical Researchers at the U

As of July 2022: Monitoring & Quality Assurance Standards for Clinical Researchers at the U

Clinical trial monitoring is an essential quality assurance (QA) activity to ensure the protection of human rights and safety, data integrity, and compliance with study protocol, applicable regulatory requirements, and GCP (Good Clinical Practice) standards.

The Clinical Research Support Office Quality Assurance Group (CRSO QA) is a University-wide resource for investigators and study teams needing monitoring/QA guidance and support. The CRSO QA offers several services to address the needs of University researchers and teams, including:

Required Services:

1.) All Investigator-Initiated Trials (IIT) where the Sponsor-Investigator (SI) holds an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) application1 will be monitored according to the CRSO QA Oversight Plan.

As of July 2022:

  • All newly approved trials meeting the above criteria will be reviewed after first participant enrollment, followed by routine monitoring. A notification in ERICA will accompany the IRB New Study Approval to identify and inform studies meeting this requirement.
  • All currently-approved active studies meeting the above criteria will be contacted by the CRSO QA Group to schedule monitoring.

1.) Any study conducted at the University that is being audited by the FDA will be pre-monitored and receive audit support by CRSO QA and the Office of Quality Compliance (OQC). Upon receipt of FDA audit notification, immediately inform the CRSO QA via email.

Optional Services:

1.) Any study being audited by a non-FDA entity, such as the IRB or study sponsor, may request pre-review monitoring services from CRSO QA.

2.) Additional quality assurance education and support are available from the CRSO QA Group. The additional services can be reviewed on the CRSO QA website.

To request CRSO QA services, please complete the REDCap Intake form, here. If a consultation is needed to determine if CRSO QA services are appropriate, please contact us here.