Human Subjects Core

The Department of Obstetrics and Gynecology Human Subjects Core (HSC) provides faculty and staff with the necessary infrastructure and resources to support for clinical research study coordination.

Our clinical research office is located just steps away from UnityPoint Health-Meriter hospital and a short drive from University of Wisconsin Hospital, which provides staff with easy access to the inpatient, general and ambulatory clinics. This ideal location has facilitated the development of well-established, research-focused partnerships between clinical and research staff as well as the ability to connect easily and promptly with a diverse, research-receptive cohort of potential subjects. The clinical research office itself is well equipped with dedicated, limited access storage for physical records, private meeting rooms and technology to support web conferences.

Human Subjects Core Services

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  • IRB submission of new protocols and amendments to local and central IRBs
  • Preparation of research authorization and informed consent documents
  • Assembly of regulatory binders
  • Support for Investigational New Drug/Investigational Device Exemption applications
  • Initial study feasibility analysis
  • Development of electronic case report forms (eCRFs)
  • Participation in site initiation visits and investigator meetings
  • Development of recruitment plans materials
  • Pre-screening potential participants via multiple electronic medical record systems
  • Obtains and documents informed consent
  • Conducts study visits according to protocol
  • Collects and enters data into CRF
  • Participation in study monitor visits
  • Develops and negotiates budget based on study protocol
  • Monitors clinical expenditures against approved budget
  • Works with the Sponosed Projects and Finance core to ensure financial compliance on projects