Central Monitoring Service (CMS)

Central Monitoring Service (CMS)

Faculty who hold an Investigational New Drug or Investigational Device Exemption must fulfill the responsibilities of both a sponsor and an investigator.  Known as a sponsor-investigator, this is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug or device is administered or dispensed. Unique obligations of a sponsor-investigator include routine monitoring to assure regulatory and protocol compliance and to confirm that data are accurate, complete, and verifiable.

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Contracted Services

UW Principal Investigators (PI’s) may contract with the CMS to monitor the progress of FDA-regulated, investigators-initiated clinical trials, and verify that the study is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, and applicable regulatory requirements.

The CMS follows standard operating procedures and detailed monitoring plans written in conjunction with the investigator and tailored to the unique needs of a trial.  Fees are determined based on study complexity and frequency of monitoring. Monitors conduct study initiation, routine monitoring and close-out visits to ensure:

• Appropriate maintenance of essential documentation
• Informed consent/assent is properly obtained for study subjects
• Eligibility criteria have been met and documented for each enrolled subject
• Adherence to the protocol and regulatory requirements
• Reported study data are verifiable from source documents
• Storage and accountability of investigational product and biological samples is adequate

Additional Services

The following compliance services are also available per request:

• Preparation for audits by FDA, NIH, or other agencies
• Once-time compliance review
• Review of research team’s compliance infrastructure and organization processes
• Assistance answering regulatory or compliance-related questions