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