Clinical and Translational Science Institute
Advancing today’s discoveries to improve health for all.

Clinical Trials Oversight

Clinical Trials Oversight

Ensure the rights and well-being of subjects are protected, data is accurate, complete, reliable and that the trial is conducted in compliance with the protocol, ICH-GCP and applicable regulatory requirements.

Support We Provide

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Data Safety Monitoring Board

Everything you need to know to create a DSMB

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Study Monitoring

Assistance with clinical research monitoring on investigator-initiated study trials.

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Independent Safety Monitor

Assistance with clinical research monitoring on investigator-initiated medical trials.

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Independent Quality Checks/Audits

Review of study conduct early in the research process

Request support with clinical trial oversight or developing a plan

FAQs

Regulatory Support

Regulatory Knowledge and Support

Regulatory Knowledge and Support enhances research operations by collaborating with internal Ohio State and Nationwide Children's Hospital research partners, core services and external entities, such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). 

Regulatory Knowledge and Support serves researchers by:

  • Accelerating the process of obtaining regulatory approvals for clinical and translational research
  • Developing and implementing efficient, compliant and ethical research proposals across all stages – from preclinical through clinical and post marketing stages
  • Providing comprehensive clinical trial oversight through development of data safety monitoring plans, study monitoring, safety monitor oversight and data and safety monitoring boards

Primary Services and Support

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Protocol/Consent Development

Plan and develop your protocols and your consent documents

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IRB Submission

Find numerous resources to help navigate the IRB

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ClinicalTrials.gov

Support to get your study registered on ClinicalTrials.gov

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Ethical Considerations

Important ethical considerations with regulatory support

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Essential Documents

Find essential documents that are used to evaluate the conduct and quality of clinical trials

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IND/IDE Support

Helping research teams navigate the investigational new drug approval process

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NIH Requirements

Support in navigating NIH requirements

Request an Regulatory Knowledge and Support Consultation

Regulatory Knowledge and Support provides expert consultations to navigate through regulatory and ethical requirements for clinical and translational research.

Request an Regulatory Knowledge and Support consultation through MyCTSI or by contacting CTSI-Regulation@osumc.edu. 

Other regulatory related questions can be directed to CTSI-Regulation@osumc.edu so that the Regulatory Knowledge and Support team can identify how to best support you.  

Additional Tools, Templates and Resources

Initial regulatory consultations are a complimentary service provided by the CTSI and funded through NIH NCATS. Estimated costs for additional services are outlined in the Regulatory Knowledge and Support service fee table. For a study specific cost calculation to be included in a grant application please contact CTSI-Regulation@osumc.edu.

Dissemination and Implementation

A doctor, a student and a patient. Patient is walking on a treadmill.

Dissemination and Implementation

The Dissemination and Implementation Science research program at The Ohio State University conducts research designed to improve health care and the organizations that practice it by fostering awareness, adoption and implementation of solutions that are backed by scientific evidence. 

Dissemination and Implementation Science focuses on:

  • Helping to develop and test effective and cost-effective strategies for disseminating, implementing and sustaining evidence-based practices within real world settings.
  • Fostering collaborations across the Ohio State community and beyond, working to achieve shared goals.
  • Training future generations of physicians, researchers, nurses and pharmacists in Dissemination and Implementation Science methodologies, tools and practices to positively impact and improve health and health outcomes.

The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST)

CATALYST is a leading interdisciplinary health services and implementation science research center that helps advance research and discovery at Ohio State.

Learn more about CATALYST

Multisite Study Support

Multisite Study Support

The CTSI is committed to strengthening relations within the translational community at Ohio State, Nationwide Children's Hospital and other CTSA institutions and research networks.

We offer resources to assist investigators and study teams to conduct multi-site clinical trials through our collaborative networks, offering investigators access to multiple research sites, shared infrastructure and operational efficiencies to improve the quality, speed and performance of your clinical research study.

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Trial-CORE

Specialized expertise and trial implementation support to faculty who seek to conduct investigator-initiated clinical trials, with a focus on multi-center clinical studies or those trials with more complex elements.

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Trial Innovation Network (TIN)

The Trial Innovation Network addresses critical roadblocks in multisite clinical research and accelerates the translation of novel interventions into life-saving therapies.

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Collaboration

Relationships already established with outside clinical options to aid in your multisite clinical research initiative.

Additional Awards and Funding

Additional Awards and Funding

Below are additional funding opportunities availble. 

ASPIRES Pilot Grant Program

The CTSI and Nationwide Children's Hospital are pleased to announce that the ASPIRES Pilot Grant Program is now accepting applications for the 2026 grant cycle. ASPIRES funds small-scale, innovative, exploratory research to advance youth suicide prevention prevention in practice settings. ASPIRES is a partnership between Nationwide Children's Hospital and Ohio State.
 

Apply Here

The Ohio State University Scarlet & Grants

Private Funding Opportunity Database

This database includes private funding opportunities. It is curated and managed by the Office of Foundation Relations (OFR) and the Office of Corporate Relations (OCR).

View the Scarlet & Grants Database

AIM-AHEAD and NCATS Health Data Science Training Program Class of 2026

Applications are now being accepted for the AIM-AHEAD and NCATS Health Data Science Training Program Class of 2026. Trainees receive six months of online training - from the basics of artificial intelligence and machine learning, to launching a first project using the real-world health data in the N3C. Online courses, weekly live classes, project guidance and 1:1 mentorship. Trainees must be able to commit 8-10 hours/week to training and receive an $8,000 stipend and $2,000 travel allowance to present their work at the AIM-AHEAD Annual Meeting in July 2026.
 
AIM-AHEAD and NCATS Health Data Science Training Program (HDSTP) - Cohort 3
The AIM-AHEAD and NCATS Training Program, through a partnership with the National Center for Advancing Translational Sciences (NCATS), was designed to reduce barriers for AIM-AHEAD researchers to access and analyze real-world clinical data. This program provides trainees with the skills and guidance needed to conduct novel research at the intersection of AI/ML and healthcare, using data collected from a broad cross-section of American communities.
 

See the Call for Applications for full details on all of the programs. Applications are due September 26, 2025 and include letters of recommendation, so act fast if you want to apply.

CTSI Training and Career Development Funding

CTSI Training and Career Development Funding

Opportunities to propel your research career.

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Predoctoral T32 Mentored Training Program

Provides full-time research training support for predoctoral trainees pursuing mentored clinical and translational research.

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Postdoctoral T32 Training Program

Provides full-time research training support for postdoctoral trainees pursuing clinical and translational data science research.

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Path to K Mentored Career Development Grant

Provides up to two years of support to faculty from health science colleges working toward writing an NIH K award.

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K12

Supports career development of investigators committed to patient-oriented and translational research.

Spark Awards

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Spark Awards

The CTSI Spark Awards are designed to support preliminary research and generate essential data for new and ongoing projects. Spark Awards provide investigators with resources to advance their research, aiming to jump-start pilot studies and support future extramural grant applications or scientific initiatives.

Applications are closed until Fall of 2026

CTSI will award Spark Awards to Ohio State and Nationwide Children's Hospital investigators worth up to $3,000. CTSI will award up to $5,000 for projects involving researchers from two different Ohio State colleges or a collaboration between Ohio State and Nationwide Children’s investigators.

Scope of Projects

Proposals must encompass activities to support a future grant application or major scientific initiative, or provide additional support critical to the success of an existing project. 

Award Amount

$3,000 - $5,000

Application Dates

Applications are closed until Fall of 2026

Complete the Spark Awards Application

Recent Spark Awardees

Portrait of Matthew Wysong

Matthew Wysong, DO, and Jenna Merandi, PharmD

They applied for a Spark Award to support their project “Building a Safer Future: Evaluating Learning Teams in a Pediatric Hospital.”

Portrait of Dr. Paola Malerba, PhD

Paola Malerba, PhD, Spark Award Recipient

She applied for a Spark Award to support her project “Neurophysiological Sleep Correlates of Cognitive Difficulties After Concussion.”

Portrait of Setty Magaña, MD

Setty Magaña, MD

She applied for a Spark Award to support her project, “Extracellular vesicles as novel, multimodal biomarkers in pediatric neuroimmune syndromes.”

Portrait of Rosie Bauder, Phd, MPH

Rosie Bauder, PhD, MPH, Spark Award Recipient

She applied for a Spark Award to support her project “Evaluating the Implementation of the 2024–2026 Suicide Prevention Plan of Ohio.”

Portrait of Priyal Patel, DO

Priyal Patel, DO

She applied for a Spark Award to support her project “Trainee Perspectives on What Factors Contribute to Comfort and Competency with Providing End of Life Care for Pediatric Patients.”

Portrait of Farah Brink

Farah Brink, MD

She applied for a Spark Award to support her project “Harnessing the Power of Natural Language Processing to Identify Child Abuse.”

For more information:

CTSI-Spark@osumc.edu

If you were looking for the CTSI voucher program, that program has been retired. While we acknowledge the value and contributions of the voucher program, we are excited to announce the Spark Awards, a new CTSI funding mechanism that will continue to support our research community.

Degree Programs

College of Medicine graduates

Degree Programs

Degree programs are available at The Ohio State University to enhance your skills, advance your career in clinical and translational science and fulfill prerequisites often required for grant applications.

Biomedical, Clinical and Translational Science Interdisciplinary Specialization

The goal of the Biomedical Clinical and Translational Science Interdisciplinary Specialization (BIOMCLT-IS) is to prepare graduate and professional students to be actively engaged in the field of clinical and translational science through academic training and research. 

The core course in this program focuses on the basic components of clinical and translational science, while the electives allow students to pursue topics across the health sciences colleges for an interdisciplinary experience.

This program or courses in this program may be required as prerequisite for some funding programs. 

Completion of a GIS is noted on the scholar’s transcript.

BIOMCLTS-IS Program Description
Instructions on applying for this specialization

Fulfilling Requirements in Responsible Conduct of Research

Download the list of courses offered to fulfill requirements (PDF)

Other Translational Degree Programs Available

Early Career Faculty

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Early Career Faculty

Career training and funding opportunities to early career faculty engaged in clinical or translational research.

Training and support designed to help early career researchers in clinical and translational research. These trainings, tools and grants aim to help promising junior faculty members receive support, mentorship and toll they need to successfully foster careers in translational research.

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Path to K

The Path to K Mentored Career Development Grant provides up to two years of support to faculty from health science colleges working toward writing an NIH K award.

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K12

The CTSI K12 Career Development Grant funds early career investigators to conduct clinical or translational research and develop their research skills as they progress to be independently funded researchers.

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Professional Trainings

Training opportunities to help progress your research career. 

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Grant Writing Support

Resources and guidance to help write successful grant proposals.

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RAPTIC

The RAPTIC program supports faculty doing innovative research in the medical, health or biomedical fields by providing coaching, learning sessions, resources and opportunities to accelerate translation and commercialization. Faculty can either choose to participate in a year-long cohort or audit a monthly learning session. 

Graduate/Predoc/Postdoc

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Graduate/Predoc/Postdoc

Training, educational opportunities and funding support for Graduate, Doctorate and Postdoctorates.

CTSI Offerings

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NIH CTSA Predoctoral T32 Mentored Research Training Program

Provides full-time research training support for post-candidacy predoctoral learners pursuing mentored clinical and translational research or science who are enrolled in any Ohio State graduate degree program.

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Clinical and Translational Data Science (CTDS) Postdoctoral T32 Training Program

The CTDS Postdoctoral T32 provides full-time research training support for postdocs pursuing clinical and translational data science research.

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Monthly Professional Development Seminar Series

The CTSI holds a series of seminars for clinical and translational science researchers focused on issues related to career development, grant writing, managing teams, research methodology, responsible conduct of research and other topics.

Other Offerings at Ohio State and Nationwide Children's Hospital

T32 Predoctoral

Information about available opportunities at Ohio State and Nationwide Children's Hospital for predoctoral fellows.

T32 Postdoctoral

Information about available opportunities at Ohio State and Nationwide Children's Hospital for postdoctoral fellows.

T Workgroup Leaders

Ginny Bumgardner, MD, PhD

ginny.bumgardner@osumc.edu

Ginny Bumgardner headshot

Sakima Smith, MD

sakima.smith@osumc.edu

Sakima Smith headshot
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