IND/IDE Regulatory Support Center
The Investigational New Drug/Investigational Device Exemption (IND/IDE) Regulatory Support Center at University Hospitals Cleveland Medical Center is a comprehensive center that exists to aid investigators during all phases of their protocol life cycle.
By reaching sponsor-investigators early in the process of their FDA pathway, sponsor-investigators and departments stand to benefit from the comprehensive services provided
IND/IDE Support Center – Core Services
- Protocol Review and Evaluation -
IND\IDE support core will work with investigators to help determine if it is necessary for a protocol to be submitted to the FDA in conjunction with local IRB review.
- Pre-IND/IDE Assistance -
IND\IDE support core will work with investigators to facilitate and submit a pre-IND or IDE submission. Support core staff will act as a liaison to effectively and appropriately communicate with the FDA and advise the investigator how to convert the submission into a full IND/or IDE.
- IND/IDE Application Assistance -
IND/IDE support core will work through the application process with the sponsor investigator and also collaborate with the investigator on subsequent responses to the FDA if necessary until approval is reached.
- Sponsor/Team Study-Start up Education -
One-on-one training is conducted with the sponsor prior to study initiation regarding their responsibilities of maintaining an FDA protocol and that all related study staff are trained on specific protocol procedures, informed consent process, etc. and are aware of and understand all delegated duties during the lifecycle of the protocol.
- Regulatory Binder and CRF Creation -
With an electronic IND/IDE clinical trial software system, regulatory documents are created, stored and maintained in a validated, password protected, part 11 compliant electronic regulatory binders.
- Monitoring Plan and Evaluation -
A formal review of the protocol is conducted and a tailored monitoring procedure is provided to the sponsor-investigator to meet the specific human subject protection and data integrity requirements of the trial (DHHS, 2011).
- Monitoring -
As defined by the monitoring plan, periodic monitoring will be conducted by the IND/IDE Core in collaboration with the sponsor for the life-cycle of the FDA protocol to ensure compliance, subject safety, and data integrity.
- Protocol Maintenance and Reporting Assistance -
The IND/IDE support core assists the sponsor investigator with all responsibilities relating to the protocol maintenance of the research study, including reports (i.e., amendments, deviations, annual reports, SAE’s)
IND/IDE Support Process
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IND/IDE Software System
The IND/IDE Regulatory Support Center utilizes an innovative software system to facilitate the electronic submission and document storage for all investigators who utilize the services of the Center.
The electronic IND/IDE Software System allows for:
- Secure, Part 11 compliance
- Storage of required regulatory documents
- Collaborative assignment of team tasks
- Generation of standard FDA documents (i.e., FDA1571, 1572, 3455, Investigator Agreements, etc.)
- Export of applications into a single, interactive PDF that can be eSigned and submitted to the FDA
For a consultation contact Jenna Stump, MS, CCRP at 216-286-0754 or Jenna.Stump@UHhospitals.org.