Regulatory Support

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Request regulatory support

Consult with an expert 

Kathy Mischke
Clinical Research Associate
misch016@umn.edu
612-625-8904 

Melissa Hansen
Research Navigator
ctsi@umn.edu
612-625-CTSI (2874)

CTSI provides expert assistance navigating regulatory requirements for clinical and translational research, including support for:


ClinicalTrials.gov submissions

Government regulations require certain studies to be listed on ClinicalTrials.gov. More recent regulations (2007) require all studies that plan to publish outcome information to be registered with ClinicalTrials.gov. CTSI will help you determine if your study should be registered, and provide registration assistance and notification of requests for updates.


IND/IDE Assistance Program

The IND/IDE Assistance Program (IAP) provides counsel and assistance to investigators regarding Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, including:

  • Determination of product classification (i.e., drug, device, combination product, biologic)
  • Applicability of an IND or IDE
  • Assistance with submission of an IND or IDE application
  • Preparation, coordination, facilitation, and attendance at FDA meetings
  • Preparation for and regulatory support during FDA inspections of investigator-sponsored clinical trials
  • Update regarding new guidance documents, inspection trends, inspection actions and new regulatory actions taken by FDA relating to clinical trials

The IAP works with CTSI's Research Project Managers (RPMs) to identify projects that may need IND or IDE assistance; to clarify and provide support for the more complex FDA mandated obligations of sponsor-investigators; and to help investigators remain compliant with the applicable research policies of the University. To assure compliance with university policies, the IAP conducts periodic reviews of research records.


Clinical trial monitoring

CTSI's clinical research associates (CRAs) assist investigators with regulatory compliance. Monitors review study materials (documents, records, drug/device accountability, Case Report Forms, etc.) to assure that the study is conducted, recorded, and reported in compliance with FDA Good Clinical Practice.

CRAs will also ensure that the study is conducted in accordance with the protocol and inclusion/exclusion criteria as approved by the IRB. CTSI monitoring services are provided at no cost to University of Minnesota investigators. Our goal is to promote and facilitate compliance with Good Clinical Practice through:

  • Regular monitoring visits
  • Quality assurance
  • Data query resolution
  • Review of study regulatory files
  • Adverse Event/Serious Adverse Event (AE/SAE) reviews
  • Compliance consultation services
  • Typical review of subject specific documents includes but is not limited to:
    • Signed informed consent/HIPAA documents
    • Case Report Forms (CRFs)
    • Medical records (for AE/SAE)
    • Regulatory binders
    • Communications with FDA/IRB
    • Investigational Product (IP) distribution logs

Request a consultation or submit a request for services