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.
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.
Available templates for FDA Submissions:
- IND Annual Report Template
- IDE Annual Report Template
- Original IDE Submission template
- IND Submission Template
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
COVID-19 update: Clinical trial monitoring has transitioned to remote monitoring only. Monitors will review all study materials that they are able to access remotely. They will complete their in-person review of non-electronic documents and finish visits when normal University operations resume. For questions, please contact Kelly McCormick at firstname.lastname@example.org or your assigned monitor.
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