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

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Questions?

CMS TEAM

KRISTEN MAHAFFEY

CMS Program Manager

Kristen is a Certified Clinical Research Professional (CCRP). She serves as the Manager of the CMS after joining UW-Madison in January of 2021. Kristen is passionate about teaming up with investigators and study teams to promote and enhance research compliance across campus.

AIMEE TOBIN

Program Coordinator, CMS & FDA Regulated Research Oversight Program

Aimee is the Program Coordinator in the CMS and the FDA Regulated Research Oversight Program, a joint venture between the Institute for Clinical & Translational Research (ICTR) and the UW Office of the Vice Chancellor for Research and Graduate Education that serves to promote and verify regulatory compliance in FDA-regulated research at UW-Madison.

MAGED MELIKA, MBBS, CRCC

CMS Clinical Research Monitor

Maged joined the UW Clinical Research Office in 2016 and became part of the CMS Program in 2021. Maged is a member of both the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA) research promoting organizations.