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.

Researchers sitting around a table while one standing at the head of the table speaks

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

ASPIRES Pilot Grant Program is now accepting applications for the 2025 grant cycle. ASPIRES funds (Funding Opportunities) are small-scale, innovative, exploratory research to advance youth suicide prevention. Generating promising pilot data can enable researchers to apply for the funding necessary to conduct larger studies. ASPIRES is a partnership between Nationwide Children's Hospital and Ohio State.

Applications are accepted through April 14, 2025. Access the application link through the RFA.

Access the ASPIRES RFA

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

Robert A. Winn Excellence in Clinical Trials Award Program (Winn Awards)

An initiative funded by the Bristol Myers Squibb Foundation, Gilead Sciences, Amgen and Genentech and led by a team at the Virginia Commonwealth University’s Massey Comprehensive Cancer Center.

More Information and Apply

CTSI Training and Career Development Funding

CTSI Training and Career Development Funding

Opportunities to propel your research career.

Predoctoral T32 Mentored Training Grant

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

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.

K12

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

Spark Awards

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Spark Awards

Introducing the Spark Awards – a new initiative from the CTSI designed to enable preliminary work and generate essential data for both new and ongoing projects.

For Researchers

Application deadline has been extended to May 15, 2025

Spark Awards are intended to provide investigators with the resources they need to effectively advance their research efforts. The Spark program is intended to jump-start research with the goal of supporting future extramural grant applications or scientific initiatives.

Eligibility:

  • Early to mid-stage career level
  • ⁠Post-Doctoral Fellow
  • Instructor, Assistant Professor
  • Associate Professor, less than two years of appointment at Ohio State/Nationwide Children’s Hospital
  • Please note: researchers in the following roles are not eligible for a Spark Award Students (undergraduate, graduate and medical), residents and CTSI funded investigators (K, T, Pilot, Element E)
  • Principal Investigator (PI) status or a letter of exception at Ohio State or Nationwide Children’s Hospital. PI eligibility information can be reviewed in the Ohio State Office of Research Study Team Lookup website.
  • Spark awardees may receive only one Spark award (single or collaborative) per funding cycle. A new funding cycle will start no earlier than August 1 of each subsequent year.
  • Exceptions may be made. Please contact CTSI-SPARK@osumc.edu for more information.
Access the full Spark Awards RFA

Award Amount

$3,000 - $5,000

Application Dates

Applications will be received through May 15, 2025, or until designated funds are exhausted.

Number of Awards

The program will make approximately 70 awards during 2024-2025.

Recent Spark Awardees

Chloe Hery

Chloe Hery, PhD

She applied for a Spark Award in November 2024, to support her research on sleep patterns and related biological factors in newly diagnosed stage I-III breast cancer patients, with a focus on underserved groups.

Jamie Boster

Jamie Boster, PhD, CC-SLP

Jamie's research surrounds augmentative and alternative communication (AAC) devices which are designed to support communication for individuals who are unable to rely on their natural speech to express themselves.

Katie Shahwan

Katie Shahwan, MD, FAAD

Her research focuses on cutaneous squamous cell carcinoma (CSCC), which is the second most common type of skin cancer. She is using her Spark Award to help Mohs surgeons identify perineural invasion (PNI).

Claire Han headshot

Claire (Jungyoun) Han, PhD, DNP, ARNP

Claire's research is about designing and developing artificial intelligence (AI) – based chemotoxicity prediction models for patients that have colorectal cancer at The James Cancer Hospital and Solove Research Institute Gastrointestinal Cancer Center.

Lora Black headshot

Lora Black, PhD, MPH

Lora's research focuses on treatments for chronic pain by using psychosocial correlates and psychological treatments.

Marissa Berry headshot

Marissa Berry, MD

Marissa's research focuses on peripartum infections in individuals with obesity, or infections that occur during late pregnancy or early post-pregnancy.

Cores Available for Funding

To Apply for a Spark Award

  1. Complete a MyCTSI Profile
  2. Contact the proposed core service and obtain a cost calculation (budget estimate) for the project. Your cost calculation must be completed before submitting your application.
  3. Complete the Spark application form. Make sure to answer all questions and attach your cost calculation.

CTSI Membership Profile

CTSI Cost Calculation Template (Word Document)

CTSI Spark Award Application

Types of Research That Can Be Funded

Spark proposals must meet at least one of these criteria: 

  • Activities to support a future grant application or a major scientific initiative
  • Provision of additional support critical to the success of an existing project

Other types of proposals will be considered on an individual basis. 

In addition, the proposals must fall into one of these categories: 

  • Clinical Research: Clinical research includes studies to better understand a disease in humans and relate this knowledge to findings in cell or animal models; testing and refinement of new technologies in people; testing of interventions for safety and effectiveness in those with or without disease; behavioral and observational studies; and outcomes and health services research. The goal of many clinical trials is to obtain data to support regulatory approval for an intervention.
  • Clinical Implementation: Clinical implementation involves the adoption of interventions that have been demonstrated to be useful in a research environment into routine clinical care for the general population. This stage also includes implementation research to evaluate the results of clinical trials and to identify new clinical questions and gaps in care.
  • Public Health: Public health includes studying health outcomes at the population level to determine the effects of diseases and efforts to prevent, diagnose and treat them. Findings help guide scientists working to assess the effects of current interventions and to develop new ones.

For 2024-2025, the program will not support basic or preclinical research proposals.

Other Requirements

Prior to receipt of funds, Spark awardees must fulfill necessary IRB/ORRP requirements, including institutional training and reporting requirements such as:

  • Reporting of conflicts of interest (COI)
  • CITI Good Clinical Practice (GCP)
  • CITI Human Subjects Protection (HSP)
  • CITI Responsible Conduct of Research (RCR)

Complete your COI

Complete Your HSR CITI Trainings

For more information:

Email

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

Whatever your role in clinical and translational research, from physician-scientist to laboratory technician to PhD student, there is a degree program that can enhance your skills to contribute to improvements in human health advance your career in clinical and translational science.

Interdisciplinary Specialization in Biomedical Clinical and Translational Science for graduate students

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.

As a result of participation in the program, it is expected that students will:

  • Develop skills in designing clinical and translational research studies
  • Apply statistical procedures to clinical and translational research problems
  • Develop skills for the communication of the scientific concepts and research questions in one’s own discipline to experts in other disciplines and to the public at large
  • Understand how to involve the community in clinical and translational research
  • Build interdisciplinary/intradisciplinary/multidisciplinary teams to study clinical and translational research issues

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

BIOMCLTS-IS Program Description (PDF)
Instructions on applying for this specialization

Translational Degree Programs Available

Fulfilling Requirements in Responsible Conduct of Research

Courses Offered at Ohio State to Fulfill Those Requirements (PDF)

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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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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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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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.

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

The T32 grant provides full-time research training support for post-candidacy predoctoral learners pursuing mentored clinical and translational research or clinical and translational science who are enrolled in any Ohio State graduate degree program.

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Clinical and Translational Scientist Seminar Series

The CTSI holds monthly Clinical and Translational Scientist Seminar Series for predoctoral and postdoctoral trainees and early career clinical and translational scientists at Ohio State.

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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