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

IND/IDE Support

IND/IDE Support

Helping research teams navigate the investigational new drug approval process.

Regulatory Guidance for Academic Research of Drugs and Devices

Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing.

For clinical trials involving marketed drug(s) for alternative use an IND Exemption (PDF) may be an acceptable alternative. The CTSI, in collaboration with the Ohio State Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.

IND/IDE Support we provide:

  • Meetings with the FDA (INTERACT, Pre-IND, Q-sub: Pre-Sub)
  • IND Submission Packet Templates
  • IDE Submission Packet Templates
  • Expanded Access “Compassionate Use” submissions
  • Clinical Hold Responses
  • Guidance and training for preparing IND/IDE initial submissions, amendments/supplements, annual reports, and withdrawals/terminations
  • Full preparation of IND/IDE submission packets
  • Guidance with determining device risk level and classification (Note: The study sponsor maintains overall responsibility for making the final determination in collaboration with the FDA and IRB)

Request support for IND/IDE submissions and FDA meetings by contacting the CTSI-Regulatory Team

When conducting human research with an investigational drug or device (drugs or devices that have not been approved or cleared by the FDA for marketing) researchers need to obtain an exemption from the pre-marketing approval requirements in the Food Drug and Cosmetic Act, prior to starting the research. This is obtained through the Food and Drug Administration (FDA) by submitting an Investigational New Drug (IND) Application or an Investigational Device Exemption (IDE). 

Once an IND is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive a study may proceed letter.  Within that 30 days the FDA may issue a clinical hold until specific items are addressed.

Once an IDE is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive an approved or approved with conditions notification from the FDA.  Within that 30 days the FDA may issue a disapproval of the research or require specific conditions be met in order to conduct the research. 

IND/IDEs need to be maintained throughout the protocol lifecycle through the submission of amendments/supplements, annual reports/progress reports, safety reports and IND/IDE termination or withdrawal.

FAQs

NIH Requirements

NIH Requirements

Support in navigating NIH requirements.

NIH Requirement support we provide:

  • Regulatory Consultations for CTSI Funded proposals (Pilot, Element E, KL2, T32)
  • Submission of CTSI Funded proposals to NCATS for Prior Approval
  • Guidance and Consultation regarding other NIH requirements

Request support for NIH requirements by contacting the CTSI-Regulatory Team

What is included in a Regulatory Consultation for CTSI Funded Proposals?

During your regulatory consultation a regulatory professional will obtain a brief description of the study from you and ask you questions about your proposed project. They will help identify the regulatory needs of your project and help link you to other resources, such as community engagement and recruitment and retention.

Additionally, the regulatory professional will help provide guidance for any required submissions, approvals, or authorizations needed for your project, including the IRB, NCATS, FDA, Research Stakeholders, IBC and IACUC.

Do all CTSI Funded Projects Require NCATS Prior Approval?

All human subject research and vertebrate animal research projects require submission to NCATS.  Any human subject research that fits under Category 1 will require prior approval from NCATS before the project can begin. Your regulatory professional will help you identify what is required for your CTSI funded project.

What other NIH Requirements Support can CTSI Provide?

Regulatory professionals can help provide guidance for researchers to meet the NIH Policies, for their NIH funded project. NIH has general policies and announcements, but important to note that each NIH Institute may have their own individual policies and requirements, such is the case for Data Safety Monitoring. 

Trial Innovation Network (TIN)

Trial Innovation Network (TIN)

The vision of the TIN is to innovatively address critical roadblocks in multisite clinical research and accelerate the translation of novel interventions into life-saving therapies.

Ohio State/Nationwide Children's Hospital is a member of the Trial Innovation Network (TIN), a collaborative partnership with investigators at the 60+ hubs in the national CTSA network.

The Trial Innovation Network can help investigators planning multi-center clinical research with the following:

  • Protocol development
  • Study operations enhancement
  • Trial budgeting guidance
  • Regulatory agreements
  • Data coordination and management
  • Clinical coordination and management
  • Data safety and monitoring
  • Site identification
  • Recruitment planning and feasibility

“The TIN was a great FREE review of our grant prior to submitting it to NIH. The TIN addressed areas of concern and potential holes in our proposal allowing us to be successful in securing funding from NIH on initial submission.”

Ohio State Investigator

There are two ways to participate in the Trial Innovation Network:

  • Inbound studies:  Researchers can participate in multisite clinical trials initiated by other network sites. These study requests are sent to the Ohio State TIN liaison team and then disseminated to investigators within the broader Ohio State/Nationwide Children's Hospital research community.
  • Outbound studies: Any researcher can submit projects of their own to be conducted using TIN network resources. Before submitting a proposal, investigators should reach out to the Ohio State TIN liaison team to learn more about which study resources available through the TIN they may want to utilize.

For more information on how the TIN can help with your research ideas, view visit the TIN website or contact CTSI-info@osumc.edu.

Multisite Trial Coordinating Center (MTCC)

Multisite Trial Coordinating Center (MTCC)

Coming Soon

History

The Ohio State University Clinical and Translational Science Institute: Then and Now

The present, past and future of the CTSI.

1 2006

The Ohio State University Board of Trustees voted to create a new entity, The Ohio State University Center for Clinical and Translational Science (later to be renamed The Ohio State University Clinical and Translational Science Institute or CTSI), to speed the translation of scientific discoveries into clinical therapies to improve human health for all. The late Dr. Rebecca Jackson, was named to lead the new enterprise based on her international recognition and outstanding leadership of numerous multi-center research collaborations. Her first task was to develop the application for a National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) grant to fund the new endeavor.

2 2008

The NIH awarded a $34-million, five-year CTSA grant to The Ohio State University and Nationwide Children’s Hospital to fund the CTSI. Among the largest research grants in the university’s history, the CTSA award was a team effort based on the clinical and translational research enterprise, training programs, informatics capabilities, trans-disciplinary collaborations and partnerships with private and public organizations.

3 2013

The NIH renewed the CTSA grant to The Ohio State University for a second five-year funding cycle with Nationwide Children’s Hospital continuing as the pediatric institutional partner. CTSA funding via a U54 specialized center, TL1 trainee program and KL2 scholar program is combined with significant local resources to provide core resources, essential mentoring and training and opportunities to develop innovative approaches and technologies designed to re-engineer existing capabilities. Program support also fosters collaborations to improve the quality, safety, efficiency and speed of clinical and translational research.

4 2018

The NIH awarded $25M to the CTSI to continue its work for an additional five years in clinical and translational science. This UL1 grant supported team science initiatives, workforce development and partnerships with private and public organizations. The CTSI also continued to partner with local communities to improve health outcomes in areas such as substance abuse, infant mortality and obesity.

5 2022

The NIH awarded a new, seven-year $37.9 million UM1 award to continue to fund the center’s work. With a "health for all" lens, this new grant will focus on the development of innovative methods and approaches to address roadblocks in clinical and translational research, support workforce development, increase collaboration across academic and scientific disciplines and expand access to research technologies. The grant supports collaborative research across The Ohio State University, The Ohio State Wexner Medical Center, Nationwide Children's Hospital and new partners, the Ohio Primary Care Innovation Network (OPCIN) and Bon Secours Mercy Health. The (OPCIN) is a partnership between the Ohio Association of Community Health Centers (OACHC) and the Ohio State CTSI to help advance health for all by placing established clinical trials infrastructure in FQHC primary care settings to serve all patients across Ohio. Healthy State Alliance is a collaboration between The Ohio State University Wexner Medical Center, the CTSI and Bon Secours Mercy Health to improve the health of communities by tackling Ohio’s most critical health needs.

6 2024

In autumn 2023, Dr. Julie Johnson was hired as director of the CTSI and contact PI of the most recent CTSA grant. To elevate the status across campus, and better align with strategic goals and Ohio State’s definition of center versus institute, the CTSI made a formal application to the university to be recognized as an Enterprise for Research Innovation and Knowledge (ERIK) institute and a formal name change to The Ohio State University Clinical and Translational Science Institute. The change was approved by Ohio State’s faculty senate in April 2024.

Dr. Rebecca Jackson

Founding Director and PI, Dr. Rebecca Jackson, 1955 – 2022

Dr. Jackson was a visionary and nationally recognized leader in the world of translational science and research. She helped establish the CTSI in 2006 as its founding director and served through 2022. While her clinical work specialized in understanding and improving women’s health, she built a legacy that lives on through her impact as a leader. She supported the education and training of translational scientists and physicians and served as a mentor to many. Dr. Jackson’s work will forever leave a profound impact for the future of medicine.

Read more about Dr. Jackson on Ohio State News

Communications Toolkit

Communications Toolkit

Before using any CTSI branded materials, please read the following carefully. It is pertinent to follow all Ohio State branding guidelines as you create your presentation, poster, etc.

Please refer to the following branding requirements:

  1. No cropping or stretching the CTSI logo
  2. Do not change the fonts or the colors on any materials
  3. Do not put more than one logo on a presentation without approval from Marketing
  4. Do not use “OSU” to reference Ohio State. Upon first reference, it must be “The Ohio State University” and then may be shortened to “Ohio State.”
    1. The same rule applies to the CTSI. First reference should be “The Ohio State University Clinical and Translational Science Institute (CTSI),” second reference can be “Ohio State CTSI,” and any references after can be “CTSI” unless you are referring to other institutions that have the same acronym. If you are, continue to use “Ohio State CTSI.”
  5. The use of oxford commas and ampersands (&) are prohibited

Resources

For more on the Ohio State brand, visit brand.osu.edu and log in with your name.#.

If disseminating anything digitally, please review the accessibility checklists.

Before presenting anything to the public, please send to ali.hinkle@osumc.edu and/or brooke.crockett@osumc.edu for approval.

Membership

Membership

Join Today! CTSI membership can make an impact on your research and career.

Benefits of Membership

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Connect and Collaborate

Find collaborators across Ohio State, Nationwide Children's Hospital and other partners and engage with Ohio communities. 

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Research Services

Connect with resources and consulting services.

ohio state researcher showing two individuals research papers on a whiteboard

Funding Programs

Gain exclusive access to internal grant funding programs.

an ohio state researcher pointing at his computer screen while two students listen and take notes

Education and Training

Participate in clinical and translational science training programs.

CTSI members are in the know! 

As a member, you will receive the CTSI Investigator, a monthly publication with the latest news, events, awards and funding opportunities across our CTSA as well as other timely communications on CTSI resources available to you.

Register Now

Membership Eligibility and Responsibilities

Members should meet the appropriate criteria below.
 

Faculty members at The Ohio State University or of partner institutions

These individuals are involved in developing and/or conducting research projects and act as principal investigators, co-investigators, collaborators or consultants.
 

Pre-Doctoral Students/Trainees

Students and trainees participating in a pre-doctoral training program provided through Ohio State or one of the CTSI partner institutions.
 

Post-Doctoral Students/Trainees

Students and trainees participating in a pre-doctoral training program provided through Ohio State or one of the CTSI partner institutions.
 

Research Staff

These individuals organize and conduct research studies at Ohio State, Nationwide Children’s Hospital or a CTSI partner institution. Research staff may include positions such as study coordinators, research assistants, statisticians or technicians.
 

Administrative Staff

This includes individuals who support investigators and research staff.
 

Other Stakeholders

This includes individuals who are otherwise involved in clinical and translational research and would like to receive CTSI communications.

Responsibilities of Membership:

  • Provide requested information when using CTSI cores and services.
  • Log publications and awards resulting from use of CTSI cores and services and respond to CTSI tracking and evaluation requests.
  • Acknowledge NIH Funding for all publications and projects that use any CTSI core or service. Cite the CTSA grant associated with your publication.

Partners

Partners

The CTSI partner network crosses institutional boundaries to improve human health and healthcare delivery. These innovative partnerships provide the foundation for addressing health for all through collaborative research and training efforts.

The Ohio State University Clinical and Translational Science Institute (CTSI) is a collaboration among The Ohio State University, The Ohio State University Wexner Medical Center and Nationwide Children's Hospital dedicated to turning the scientific discoveries of today into life-changing disease prevention strategies and the health diagnostics and treatments of tomorrow for all.

Nationwide Children's Hospital logo

Nationwide Children's Hospital

Nationwide Children's Hospital (NCH) is our pediatric partner on the CTSA award. This partnership makes The Ohio State University's CTSA hub unique by having a nationally recognized pediatric partner on its CTSA award and providing an opportunity for collaborative lifespan research.

Our Partnership with NCH
Opcin logo

Ohio Primary Care Innovation Network

The Ohio Primary Care Innovation Network (OPCIN) is a partnership between the Ohio Association of Community Health Centers (OACHC) and the Ohio State CTSI. This research partnership was formed in 2022 and helps improve health for all by placing established clinical trials infrastructure in FQHC primary care settings to serve patients across Ohio who face a high burden of health and to be more broadly represented in research.

Our Partnership with OPCIN
Bon Secours Mercy Health logo

Bon Secours Mercy Health

Healthy State Alliance is a collaboration between The Ohio State University Wexner Medical Center, the CTSI and Bon Secours Mercy Health. Healthy State Alliance is a bold ambition to make a difference in improving the health of communities by tackling Ohio’s most critical health needs.

Our Partnership with Bon Secours

The Business of Science 2024

The Business of Science 2024

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