RIM: Research and Research Education

Regulatory Support

Regulatory Support provides the following services:

  • Consultation in regards to IND/IDE requirements
  • Consultation in regards to IND exemption
  • Consultation for Sponsor-Investigators
  • IND/IDE submission support
  • Maintenance and regulatory support for INDs/IDEs
  • Standard Operating Procedures (SOPs) – Guidance, review, evaluation, etc.
  • Assistance with interpretation and implementation of guidelines (FDA guidance documents, ICH-GCP, etc.)
  • Assistance with research specific forms: AE logs, con-med logs, delegation of authority logs, etc.
  • Project management
  • Collaborate with UM CTSI’s regulatory support initiatives
  • Investigational New Drug (IND)/ Investigational Device Exemption (IDE) consultation for Sponsor-Investigators
  • IND/IDE submission support
  • Maintenance and regulatory support for INDs/IDEs
  • Assistance with interpretation and implementation of regulations and guidelines (FDA CFR, guidance documents, ICH-GCP, etc.)

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