FDA Guidance Core

Through the CTSC, the FDA Guidance Core is an efficient, comprehensive, and standardized resource that exists to aid investigators during all phases of their protocol life cycle. By reaching sponsor-investigators early in the process of the FDA process, sponsor-investigators will benefit from the comprehensive services available through the Core:

IND-IDE Regulatory Support Core

  • Protocol Review and Evaluation
    Determination of most effective route with the FDA
  • Pre-IND/IDE Assistance
    Facilitate the creation and submission of a pre-IND or IDE
  • IND/IDE Application Assistance
    Comprehensive support for the sponsor investigator through the application process with the FDA
  • Research Data Management Plan
    Consultation and assistance on compliant data management and storage
  • Sponsor/Team Study-Start up Education
    Intensive one-on-one training for sponsor-investigators and research personnel prior to study initiation
  • eRegulatory Binder and CRF Creation
    FDA documents stored electronically and maintained in a validated part 11 compliant system.
  • Monitoring Plan and Evaluation
    Monitoring tailored for specifically for investigator initiated protocol
  • Quality Control and Quality Assurance Evaluation
    Evaluate and assist in establishing the QC and QA Plan for the study
  • Long-term Protocol Maintenance and Reporting Assistance
    Long term protocol assistance available for the duration of the research trial

For more information, contact:

Jenna Stump, FDA Regulatory Specialist (216) 286-0754 or Carolyn Apperson, RKS Co-Director (216) 368-0035
Have FDA related Questions, email the Core: ctsc-fda-guidance-core@case.edu