Regulatory Support

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

ClinicalTrials.gov submissions

Investigational New Drug (IND) and
Investigational Device Exemption (IDE) applications

Clinical trial monitoring

Regulatory specialists

IND/IDE Assistance Program

CTSI's IND/IDE Assistance Program is a collaborative effort with OVPR's Human Research Protection Program (HRPP).

The IND/IDE Regulatory Director within HRPP can help investigators determine whether a protocol requires a submission to the FDA. All services available from the IND/IDE Regulatory Director can be found in the University Policy Library.

Once you determine whether you need an IND or IDE, the CTSI IND/IDE personnel can help you submit the appropriate documents required to the FDA.

Assistance with submitting formal IND/IDE determination requests to the FDA
Assistance with pre-IND/IDE/BLA or other pre-submission queries
Assistance with submission of an IND or IDE application
Assistance with annual reports, and safety reporting to the FDA
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

Please note, the CTSI IND/IDE Assistance will work collaboratively with the IND/IDE Regulatory Director within the HRPP and will not challenge determinations made by the HRPP.

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

Regulatory specialists

CTSI’s regulatory specialists provide guidance and support for clinical trials ranging from navigating the IRB submission process to maintenance of study documents (regulatory binder/ Investigator Site File).

The regulatory specialists help ensure your study files follow Good Clinical Practice guidelines, can help reduce the number of common stipulations on your IRB submissions, and can identify other useful resources for your specific study.

Types of support include:

Completion of start-up materials only (IRB submission start-up through initial approval)
Ongoing IRB document completion, such as submitting report forms, summarizing study changes, etc.
Consultation on IRB submissions and regulatory document maintenance

View Rates

Consult with an expert

Kelly McCormick
Regulatory Manager
612-624-3315
[email protected]

Sydney Viel
Regulatory Specialist Manager
[email protected]

Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)

Regulatory Support

Consult with an expert

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