UW-Madison Investigator Held IND/IDE Resources

The below are the policies, training offerings and services available for UW-Madison investigator held INDs/IDEs

IND/IDE Registration: 

The FDA Regulated Research Oversight Program maintains a registry of all UW-Madison investigator-held INDs/IDEs to ensure institutional compliance with the FDA requirements and assist investigators in fulfilling their FDA obligations.

• UW-Madison personnel must initiate the IND/IDE registration process with the Program no later than the time of submission to the FDA. Further guidance on the UW-Madison IND/IDE registration process is available at: [insert link of registration instructions] 
• UW-Madison personnel must also notify the Program when an IND/IDE has been closed, terminated or withdrawn. 
• UW-Madison personnel seeking guidance on the FDA IND/IDE submission process may consult with the ICTR IND/IDE Consultation Service (I3CS)

FDA Regulated Research Oversight Program Compliance Reviews:  

Program staff perform routine compliance reviews (referred to as Routine Reviews) to ensure that clinical trials conducted under a UW-Madison Investigator held IND or IDE are conducted in compliance with applicable laws, regulations, policies and guidelines and in line with the Program mission and the UW-Madison institutional compliance oversight obligations. 

Routine Reviews are performed at the behest of the Institution with no associated fees. Program Routine Reviews do not take the place of or fulfill the requirements for reviews conducted by other internal or external monitoring programs. 

Protocols that meet the following criteria will undergo Routine Reviews: 
 • Protocols in which the UW-Madison investigator holds an IND and/or IDE (this does not include clinical trials conducted under an IND or IDE held by another organization).
 • Protocols with an IRB status of “Approved” that have been opened to accrual and enrolled subjects.  

Protocols meeting the above criteria will undergo Routine Review regardless if the study is currently, or has been monitored by an independent entity (e.g., Post-Approval Monitoring (PAM) Program, ICTR Study Monitoring Service [SMS], independent contract research organization [CRO], etc.) 

External Audit/FDA Inspection Notification and Preparation:

Research staff are required to contact the Program upon notification of an inspection by the Food and Drug Administration (FDA) or of an audit by another external agency (e.g., National Institute of Health (NIH), Office for Human Research Protections (OHRP), U.S. Department of Agriculture (USDA), etc.). 

The Program provides support and guidance prior to, during and following external audits and inspections.

 The support and guidance available to research staff includes but is not limited to pre-audit/inspection consultation meetings, compliance reviews and training for staff involved in audits/inspections and are provided at no cost.

 Training and Education

 The Program manages two online courses: 

For a complete list of training requirements and opportunities, refer to the Education and Training webpage managed by the Office of Research Compliance. Program staff may provide additional training upon request or identification of compliance deficiencies. 

Resources and Who to Contact for Investigators that Hold the IND/IDE:

FDA Regulated Research Oversight Program: 

The FDA Regulated Research Oversight Program (referred to as the Program) provides UW-Madison Investigators who hold an Investigational New Drug (IND) or Investigational Device Exemption (IDE) with the tools, resources and assistance needed to successfully conduct Food and Drug Administration (FDA) regulated research. 

The Program is not an office, but rather a collective, multidisciplinary effort of individuals across the institution. The Program collaborates with other University entities, including the Health Sciences Institutional Review Board (HSIRB), Human Research Protection Program (HRPP), Carbone Cancer Center (CCC), Pharmaceutical Research Center (PRC), ICTR IND/IDE Consultation Service and the Office of Legal Affairs. The program activities are managed and facilitated by the Institute for Clinical and Translational Research (ICTR). 

To learn more, ask general questions and/or inquire about available resources and services, contact 

Tracy Ohrt, Administrative Director Tim Sparks, Scientific Director 
Email: tracy.ohrt@wisc.edu Email: tim.sparks@wisc.edu 
Phone: (608) 262-7505)                                  Phone: (608) 265-3158

Keywords:IND, IDE   Doc ID:85093
Owner:Faye L.Group:Health Sciences IRBs
Created:2018-08-21 15:33 CDTUpdated:2018-09-25 10:27 CDT
Sites:Health Sciences IRBs
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