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

Study Start-up

Study Start-up

Support in the beginning stages of your study.

Data Collection Tools/Databases

There are three databases used regularly at The Ohio State University. The ones that are currently FDA 21 CFR part 11 compliant are designated with an asterisk. This means they are able to meet the FDA standards which is necessary for implementation of trials involving an IND/IDE.

  • REDCap is an open source tool that provides study staff with tools to manage projects, participants and research data. The CTSI can assist researchers to develop studies utilizing REDCap.
  • Oncore Database* is available only to staff within the College of Medicine 
  • StudyTrax* permits the user to build data collection forms as web pages. StudyTrax comes with built-in report and dataset generators; data can be exported to SAS or SPSS formats, Excel or Word. StudyTrax explicitly supports multicenter trials with an option to define sites. 

The CTSI can help ensure you have created a good clinical database and how to capture items to be easily accessed by the statistician later. Reach out to CTSI-info@osumc.edu for a free consultation.

REDCap Boilerplate Language for the IRB or Grant Application

This is a template that can be used for the IRB Application when utilizing REDCap for a registry protocol.

Access REDCap Boilerplate Language

Consent Document Preparation

Support for drafting, revising and finalizing consent documents

In addition to providing consent process and document support, a library of template language for various study procedures and their respective risks has been created for access and use by the research community. These may be accessed below:

Regulatory Documents Master Trial Folder

Essential documents are commonly referred to as regulatory documents. International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.”

A trial master file should be established at the beginning of any research study and maintained throughout the study. This file aids in the management of the study and is often a piece that is audited by study monitors and FDA officials. Unless otherwise noted, copies of all documents should be placed in the master file at the site and with the study sponsor or Contract Research Organization (CRO).

This Master Clinical File Guidance template outlines the required documents according to ICH E6 Guidance for Industry: Good Clinical Practice (GCP) (PDF). At the industry level and the site level.

Fiscal Management

After an award has been accepted and/or a contract signed by the Office of Sponsored Programs (OSP) on behalf of the Principal Investigator (PI), the Office of Grants and Contracts (OGC) will establish and award number(s) when the following items are in place:

  • The Ohio State Financial Conflict of Interest Screening/Disclosure Form (eCOI) (required at proposal stage) completed by the PI and approved by the Office of Research Compliance
  • Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approval (if applicable)
  • Fully signed contract or award on file at OSP
  • All effort reports have been certified or are in the process of being corrected for all of the investigator’s projects

Some awards may also require additional agreements be in place, such as technology commercialization plans, confidential disclosure agreements or conflict of interest management plans. Conflict of interest management plans are handled by the ORC.

The OSP award number is a unique number that starts with AWD–six digits (example: AWD-123456). The award number is where study documents and study details are saved on the project in the PI Portal. The award number is typically used by OSP employees when they communicate with PIs. It is also one of the identifiers that can be used to obtain project-related financial information from the OSP electronic research administration project management tool (PI Portal). The award number is NOT what a PI or study team would use to purchase services on.  

After the award has been received and the project is set up. The Sponsored Program Officer (SPO) will create separate grant numbers associated with the project to allow one to spend on. They will be listed with GR and six digits (example: GR123456). The reason behind making a separate grant number is to easily track spending restrictions on the funds received. Awards will have at least one grant number assigned but could have several grant numbers assigned.   

Examples of why you would have additional grant numbers on a project:

  • You have a subaward on your project. There will be a separate grant number associated for your subaward and one for spending that will occur at Ohio State. The budget will be split on the grant numbers as it was defined in the grant submission.
  • The sponsor limits salary spending on the notice of award to $100,000 and the remaining funds are to be used for clinical tasks. The SPO will set up one grant number for the salaries and one for the remaining charges.
  • The PI should separate clinical fees for the trial from the rest of the expenditures to stay on budget. The PI can request that the SPO creates two grant numbers.

Note: Even if the project comes from industry it is still listed as a grant number in the PI Portal and Workday system.  

Investigators and their staff are responsible for reviewing all project costs to ensure they are reasonable and appropriately assigned to the project, must approve purchases greater than $3,000 and must approve payments to sub awardees. The OSP is responsible for completing all purchase transactions, issuing payments, processing travel reimbursements and human subject payments and billing sponsors.

The following items are best covered on the Office of Research Page- Award Management.

The Sponsored Program Officer and Grants Manager is the best resource to check on how to complete the following and any questions on your project.  

Researchers should also follow the Award Closeout Process.

Drug Supply Management and Accountability

The record keeping associated with the receipt, storage and dispensation of an investigational product is known as study drug accountability. While the study sponsor is responsible for packaging and distributing the product to the study sites, it is the responsibility of the site to maintain adequate records of the products’ handling and dispensation.

Often sponsors will provide tools such as tracking logs to assist in the maintenance of such records. However, if no tools are offered by the sponsor, the site should plan to develop their own tracking method. For all hospital-based drug studies, Investigational Drug Services is responsible for managing the research study drug supply and drug accountability records.

Investigational Drug Services Policy and Procedure (PDF)

Packaging

Study drugs will often be packaged to protect the product, ease dispensation and to preserve blinding when necessary. Typically the packaging will offer a place to record the study participant ID.

Receipt

When a study drug is received at the study site, it is important to inspect the shipment in its entirety. The packing slip should be compared to both the order form and the contents of the shipment. Often study sponsors will require that the packing slip be signed, dated and returned in order to acknowledge receipt of the shipment. If it appears that the shipment is incomplete or was damaged in transit, contact the sponsor immediately.

Storage

Storage instructions should be included with the shipment, including specifications for temperature ranges. Study drugs should always be stored in a secure location, either at the study pharmacy or in a locked cabinet within a separate locked room. Temperature logs should be maintained in the storage area to ensure that the product remains viable.

If a study drug requires storage in a refrigerator, the refrigerator should have a lock on it and should remain free of food. This means that study drugs cannot be kept in the break room refrigerator. Likewise, lunch cannot be kept in the study drug refrigerator.

Dispensation

The tracking of study drug dispensation can become complicated with many study participants over the course of a lengthy trial. Meticulous records are required in order to be compliant with accountability. Study drugs received from the sponsor should be tracked, as well as drugs dispensed to study participants.

Bon Secours Mercy Health

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, one of the largest health systems in Ohio.

Bon Secours Mercy Health (BSMH) is one of the largest health systems in the United States with a network that extends to more than 1,200 care sites and 49 hospitals serving patients more than 11 million times annually, serving communities in Florida, Kentucky, Maryland, New York, Ohio, South Carolina and Virginia, as well as throughout Ireland. 

In 2023, BSMH provided more than $600 million dollars in community investments across five states, ensuring that cost is not a barrier to health care for our patients in need. In addition to charity care, BSMH invests in programs that address chronic illness, affordable housing, access to healthy food, education and wellness programs, transportation, workforce development and other social determinants of health that directly affect the communities we serve. 

The partnership with Bon Secours Mercy Health is a direct result of the Healthy State Alliance, a strategic initiative between The Ohio State University Wexner Medical Center and BSMH to transform the health of communities served in Ohio, and beyond, by impacting the most critical health issues these populations face. 

The unique partnership brings together not only the resources and technology needed to tackle the most critical health needs in Ohio communities, but the caring and compassionate expert providers and researchers who are on the front lines solving the most challenging issues facing patients today. The alliance is committed to transforming the health of the communities we serve, while making health care more affordable and accessible for all. Together, we will drive the change that is needed to create a new state of health in Ohio and beyond.

 

Learn more about the partnership between Bon Secours and Ohio State

Learn more about Healthy State Alliance

 

OPCIN

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The Ohio Primary Care Innovation Network (OPCIN)

The Ohio Primary Care Innovation Network (OPCIN) is a partnership between the Ohio Association of Community Health Centers (OACHC) and The Ohio State University Clinical and Translational Science Institute (CTSI).

The OPCIN, co-founded in 2022 by Dr. Seuli Brill of The Ohio State University and Dr. Dana Vallangeon of the OACHC, interfaces Ohio’s robust Federally Qualified Health Center (FQHC) network with the translational science infrastructure of the CTSI. 

OACHC FQHC has a network of more than 511 locations, serving 76 Ohio counties and completing more than 3.8 million patient visits.

The OPCIN Ohio State/OACHC statewide pragmatic research partnership catalyzes and advances health for all through placing established clinical trials infrastructure in FQHC primary care settings to serve patients across all of Ohio.                                                                                        

The OPCIN operates using a shared governance/decision-making model between Ohio State and OACHC to facilitate advancement of community, healthcare and patient stakeholder-led research priorities that align with OACHC and Ohio's State Health Improvement Plan (SHIP) strategic priorities. 

The OPCIN infrastructure ultimately seeks to: 

  • promote dissemination and implementation of clinical innovation into real-world environments;
  • accelerate efficient clinical translation into communities;
  • and foster community partnership in innovation;

Between July 2022-July 2023, the OPCIN has contributed to seven single-site and multi-site extramural funding applications and sub-contract applications to the federal agencies: NIH (NCATS, NIDDK, NICHD, NIDA/HEAL); PCORI, AHRQ and HRSA.

Nationwide Children’s Hospital

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Nationwide Children's Hospital

One of the largest pediatric hospitals in the United States with a longstanding reputation as a destination academic pediatric medical center designed to manage the most complex of diseases.

With more than 1.8 million patient visits each year, Nationwide Children's has a vision to transform child health so children everywhere achieve best outcomes. Families travel from around the nation and across the globe to access life-saving treatments – many unavailable anywhere else.

As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists.

The Abigail Wexner Research Institute at Nationwide Children’s is one of the top 10 National Institutes of Health-funded free-standing pediatric research facilities in the US, supporting basic, clinical, translational,  behavioral and population health research. The AWRI receives funding annually in support of CTSI activities. Faculty members on the Nationwide Children’s campus are eligible to compete for pilot and training grants originating from the CTSI and utilize shared resources.

Learn more about Nationwide Children's Hospital
Our Collaboration with Nationwide Children's Hospital

Resources for Community Members and Partners

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Resources for Community Members and Partners

Research requires the help of everyone, not just doctors or researchers, and Ohio community members are excellent partners. There are numerous ways to get involved, whether it be participating in research or being a part of the research process.

The Ohio State CTSI offers courses specifically for community members about the importance of clinical trials and trains them to be an impactful member in the world of innovative medicine.

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Community Scientist Academy (CSA)

The Community Scientist Academy increases community stakeholders’ awareness and understanding of research and to increase engagement throughout the entire translational research process.

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Academy of Community Reviewers (ACR)

The Academy of Community Reviewers provides training for patients and community members to review scientific research proposals, provide meaningful perspectives and contribute towards grant decision-making.

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Appalachian Translational Research Network (ATRN)

The Appalachian Translational Research Network's mission is to improve health outcomes across Appalachia by fostering collaborative inter-institutional and community-academic research partnerships.

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Community Engagement Toolkit for Community Members

Explore community engagement resources for community members and partners.

Contact Us

For more information contact Community Engagement Team Manager, Jeff Grever.

Email

Jeff.Grever@osumc.edu

Phone

614-366-5953

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Cite the Grant

Cite the Grant

CTSI’s Clinical and Translational Science Award (CTSA) provides essential infrastructure, resources and services that support clinical and translational research at The Ohio State University, Nationwide Children’s Hospital and across Ohio.

Publications are essential to showing Congress, the NIH and our partners that CTSI is effective at facilitating translational research. Since our initial award in 2008, more than 1,233 publications have cited the CTSI’s CTSA grant and have been included in progress reports to the NIH. Help CTSI continue to provide essential support for clinical and translational research by using our citation to credit the CTSA grant.

Citation Guidance

When Are You Required to Cite the CTSA grant?

  • When the research was directly funded by CTSI: pilot projects awards, tech development grants, Community-Engaged Scholar Program awards, Research Nexus subsidy awards, KL2, TL1 support
  • When the research benefited from CTSI-funded faculty or staff
  • When the research relied on CTSI services, resources, facilities, tools or consults such as: CTSI Voucher Award, research navigation, biostatistics, informatics, regulatory support, recruitment and retention support (ResearchMatch, StudySearch, Facebook Ads, etc.), study coordination, technology consults, study design, community engagement and special populations consults
  • Resources: toolkits, training workshops, courses, seminars
  • Informatics Tools: REDCap, clinical data warehouse, Scarlet, LifeScale

Please consider citing the CTSA grant for these situations:

  1. When CTSA involvement is less direct, the decision to cite the CTSA grant in papers is at the discretion of the senior author. Given the importance of publications to demonstrating the transformative power of the CTSI, we ask that you consider citing the CTSA
  2. CTSI involvement that qualifies for citing the CTSA:
    1. Technical assistance, such as statistical assistance, helped accomplish a portion of the research, but the personnel were only partially funded by the CTSA; If the technical expertise played an important role, then citation of the CTSA may be appropriate.
    2. Faculty with partial FTE from the CTSA grant should consider whether their CTSA funding provided some support for a research project which would qualify for CTSA grant citation.
    3. Other assistance from CTSI personnel may have been important to the research in question; CTSI faculty and staff are often involved in initiating and supporting collaborative research, coordinating critical meetings of collaborators and stimulation of novel ideas; These activities should be considered for citation of the CTSA grant.

“This publication [or project] was supported, in part, by The Ohio State University Clinical and Translational Science Institute (CTSI) and the National Center for Advancing Translational Sciences of the National Institutes of Health under Grant Number UM1TR004548. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.”

Recommended Citation Language
Citation language for activities supported after June 1, 2018.

NIH Public Access Policy

Investigators are required to acknowledge federal funding on research publications, press releases, requests for proposals, bid invitations, and other documents supported in whole or in part with NIH funds. Authors are required to comply with the NIH Public Access Policy, which includes submission, upon acceptance for publication, of an electronic version of the final, peer-reviewed manuscript to PubMed Central. The NIH will not acknowledge any publications not in compliance with this policy and may withhold funding on grants not in compliance.  Compliance is monitored via a PubMed Central ID (PMCID), which must be included in bibliography listings of these publications.  

NIH Public Access Policy

Author Affiliation Guidelines

Faculty and staff at The Ohio State University Wexner Medical Center are inconsistent in their approach to author affiliations when submitting publications. This impacts how the medical center and its entities are represented in various bibliometric data. These data are important when tracking author or researcher output and impact and are key in decisions related to promotion and tenure, as well as securing external funding. 

To address this inconsistency and to improve bibliometric results, the medical center is implementing a new author affiliation structure for publications. In general, the author’s affiliation structure will be written as follows if working with the CTSI: 

Division of ______, Department of ______, Clinical and Translational Science Institute, College of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH, USA  

Review the Author Affiliation Guidelines

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

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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.

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