Investigator Initiated Trial Services at the U (IITS-U)

The IITS-U monitoring program assists UM investigators holding INDs or IDEs with their obligation, as per FDA regulations, to ensure proper monitoring of the investigation(s) and to ensure that the investigation(s) is conducted in accordance with the general investigational plan and protocol. 

A risk-based approach will be taken for all studies monitored by IITS-U. For each study, the risk level will be assessed. Risk factors such as objective(s), purpose, design, complexity, blinding, participant population, number of trial participants, investigational product, current knowledge of the investigational product safety profile and endpoint will be assessed. According to the determined level of risk, an individualized monitoring plan will be created for each study. 

During the monitoring process, IITS-U will assist the sponsor/investigator by: 

• Review of participant informed consent document and process 
• Review of subject eligibility for the trial 
• Review of safety i.e. adverse event reporting 
• Review of compliance with the protocol, regulations and institutional policies 
• Targeted review (based on the monitoring plan) of the accuracy, completeness and consistency of reported trial data against the source records and other trial-related records and whether these were reported in a timely manner 
• Ensuring that corrections, additions or deletions to case report forms are made as appropriate, dated, explained (if necessary)
• Providing customized training to the study team based on any issues found during the monitoring visit
• Confirming that the investigator is maintaining the essential records 
• Review of investigational product accountability 
• Reporting what was reviewed, significant findings, conclusions, actions required to the Principal-Investigator and/or Sponsor-Investigator 
• Follow-up with study team to resolve issues and action items. 

The IITS-U 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. 

The IITS-U Regulatory Support provides the following services: 

• Consultation regarding IND/IDE requirements 
• Consultation regarding IND exemption 
• Consultation for Sponsor-Investigators
• IND/IDE submission support 
• Maintenance and regulatory support for INDs/IDEs 
• Standard Operating Procedures – 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