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Compliance Program

Compliance Program

Research

Research Compliance Program

Clinical research is highly complex and governed by both federal and state regulations.   Some risk factors that can affect our institution include: human subject protections, research grant and trial accounting, effort reporting, scientific misconduct, privacy data and security and clinical trials billing.  The Research Compliance Program was developed to mitigate risks associated with clinical research and to promote the integrity of research at our institution.

Services provided by this program include:

  • Policy review and developments,
  • Clinical trial billing audits to ensure claims for items and/or services have been  appropriately billed,
  • Review of preparatory to research and research on decedent requests,
  • Surveillance audits – related to researcher(s) access to PHI,
  • Accounting of Disclosure audits,
  • Monitoring of Consent Forms for active and enrolled subjects uploaded in EMR,
  • Investigations pertaining to research misconduct, and
  • Education and training support

Guidance and Tools

About Our Staff

Sharalyn Reed, JD, MPH, CHC
UCDMC Privacy Program Director

Gina Guillaume-Holleman, CHRC, CCRP, CPC
Research Compliance Analyst VI