Study Monitoring Service (SMS)

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.

Feel free to request a consultation for additional information.

Contracted Services

UW faculty may contract with the SMS 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 SMS 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

Complimentary Services

The following compliance services are available at no cost:

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

 

Contact Us

Jacob Rome

Position title: Administrative Director, FDA Regulated Research Oversight Program

Email: rome2@wisc.edu

Molly Lumley

Position title: Quality and Compliance Monitor, Clinical Research Services & Networks

Email: molly.lumley@wisc.edu