Regulatory Support & Advocacy Services

The Regulatory Support Core offers personal consultations in the following research areas:

  • FDA Submissions-¬†Investigational New Drug (IND)/Investigational Device Exemption (IDE) Initial Applications
  • IRB Submission
  • Protocol Development
  • Adverse Experience and Unanticipated Problem Reporting
  • Registration
  • Certificates of Confidentiality
  • Conflict of Interest
  • Clarification of specialized regulatory issues
  • Individualized Education and Training¬†on the practical application of Good Clinical Practice

People who use regulatory support services also find the following links helpful:

UIC IND Policy
UIC IRB Homepage
UIC Research Protocol Template
UIC Prompt Reporting: See "When Problems Occur"
UIC Unanticipated Problems
FDA MedWatch Form Homepage Registration
UIC Certificates of Confidentiality Guidance
UIC Conflict of Commitment and Interest (COI)
UIC OVCR COI Education & Training
UIC Policy on Conflict of Interest Disclosure for Human Subject Research
UIC Human Subject Protection Education & Training
UIC Responsible Conduct in Research Training and Certification
UIC CCTS CIRTification: Human Subjects Protection Training for Community Partners