CRORS provides regulatory support for Investigator-initiated studies for which the Investigator wishes to submit an Investigational New Drug or an Investigational Device Exemption application with the FDA.
Upon contacting the CRORS office, a consultation will be scheduled to discuss the study idea and current status in order to provide the appropriate guidance and cost estimate for any regulatory support services provided by our office. CRORS 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.
- Collaborate with UM CTSI’s regulatory support initiatives