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

Publication Tools

Publication Tools

Support for drafting, revising and finalizing publications.

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EQUATOR Network

Standard guidelines for research publications can be found on the EQUATOR Network website.

Access EQUATOR
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ICMJE Recommendations

The International Committee of Medical Journal Editors (ICMJE) developed recommendations to review best practice and ethical standards in the conduct and reporting of research and other material published in medical journals, and to help authors, editors and others involved in peer review and biomedical publishing create and distribute accurate, clear, reproducible, unbiased medical journal articles. The recommendations may also provide useful insights into the medical editing and publishing process for the media, patients and their families, and general readers.

Access ICMJE
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Ohio State Authorship Guidelines

Assigning authorship on a scientific or scholarly manuscript or creative expression performs a dual role. It apportions credit for the contribution of each individual while also explicitly assigning responsibility. Designated authorship allows others to assess the relative input of each author to the impact of an intellectual endeavor, including original scientific research, words and images, and works of art, music or dance. These scientific or scholarly manuscripts or creative expressions might be intended to disseminate innovations, discoveries or novel ideas, review existing work, or solely for educational purposes. Authorship roles are used as important metrics in establishing renown, advancing academic standing, and facilitating grant funding of individuals.

Ohio State Authorship Guidelines

In addition, research utilizing CTSI support must cite the CTSI Grant.

Cite the Grant

Study Closure

Study Closure

Best practices after the completion of a study.

Fiscal Management

Approaching the end of grant term make sure all of your subcontracts that have been invoiced for their work are completed and received. Do not leave large encumbrances. Researchers should also follow the Award Closeout Process.

Maintenance and Storage of Research Records

Under Maintenance and Storage of Research Records - update to state "Research records must be maintained per FDA regulations, IRB policy and institutional policy. Many departments are contracted with Records Control (formerly Fireproof). Records Control can be contacted at 614-299-2122.

It is important for study teams to keep a log of where the records are stored, what is in each box, and how to retrieve the records at a later time.

Research records must be maintained per FDA regulations, IRB policy and institutional policy.

  • FDA Regulated Drug Studies - The Investigator/Sponsor must maintain all records for at least two years after the New Drug Application (NDA) has been approved, or if a NDA is not approved for the drug until 2 years after shipment and delivery of the drug for investigational use is continued and the FDA has been notified.
  • FDA Regulated Device Studies - The Investigator/Sponsor must maintain all records for at least two years after the latter of the following two dates: 
    • The date on which the investigation is terminated or completed
    • The date that the records are no longer required for purposes of supporting a premarket approval application (PMA), a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission or a request for De Novo classification.
  • Ohio State IRB policy - The investigator will retain
    • Research-related records (protocol, IRB correspondence, etc.) for at least three years after the research has ended
    • Consent forms/HIPAA authorizations for at least six years after the study has closed
    • Primary research data (source documentation and case report forms) for five years after final project closeout. 
  • The Ohio state University Records Management Policy can be found at policies.osu.edu. 
File to Sponsor (Word Document)
Track Storage Records (PDF)

ClinicalTrials.gov

For Investigator Initiated Trials (IITs) the Principal Investigator (The Responsible Party) is responsible for entering the study results in ClinicalTrials.gov within 1 year of meeting the primary completion date, for all NIH sponsored Clinical Trials, and for any Clinical Trial that is an Applicable Clinical Trial (ACT).

Primary Completion Date - the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome measure.

Training for entering study results in ClinicalTrials.gov can be found below.

Access training for entering study results

Regulatory Closeout

Investigator Site File (ISF)

The Principal Investigator (PI) should ensure all the essential documents are collected and filed. Stop dates for all study team members should be added to the Delegation of Authority (DOA) log. A final Financial Disclosure Form (FDF) should be collected from all investigators working on the study within one year of study closure.  

For multi-site studies the PI is responsible for collecting all sub-site essential documents for the Master Trial Folder (MTF).

FDA Closeout

Investigators holding an IND/IDE with the FDA must submit their IND withdraw or IDE Final Report.  For assistance with preparing a FDA closeout submission please place a request.

IRB Closeout

Investigators should submit a study termination notification to the IRB of Record.  For Investigators overseeing multi-site Investigator Initiated Trials (IITs) they need to ensure all sub-sites close have complete.   

IACUC/IBC Closeout

For studies that include IACUC and/or IBC reviews, the study closures should be completed in the IACUC and/or IBC portals and records should be saved and maintained.

Resources for Researchers

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Resources For Researchers

Community Engagement resources for researchers to help connect with the community and support stakeholder-engaged research.

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Community Engagement Research Consultations

The Community Engagement (CE) Program offers consultation and engagement resources to help building productive relationships with community stakeholders and organization.

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Southeast Ohio Community Advisory Board

The Southeast Ohio Community Engagement Advisory Board (CAB) was established to give the community a voice and provide an avenue for researchers to collaborate with the community.


 

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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 Resource Room

Explore resources to help community partners and Ohio State and Nationwide Children's Hospital research teams identify a place to start when it comes to engaging stakeholders in the translational research process.

Contact Us

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

Phone

614-366-5953

Email

Jeff.Grever@osumc.edu

portrait of Jeff Grever wearing a red tie smiling for the camera

Active Trial

Active Trial

Key steps to take during an active trial.

Study Implementation Meeting

After a study receives IRB approval, it is important to have a formal study implementation meeting with all internal key personnel. The focus of the implementation meeting is to ensure that all budget, contract, nursing, data collection, laboratory and other protocol-specific issues have been resolved prior to opening a study to participant accrual. This is also the opportunity to ensure that all key personnel have completed any protocol-specific training and are familiar with the expectations of the protocol and investigator responsibilities and the delegation of responsibilities.

The implementation meeting is a detailed planning session involving the key personnel associated with the study. Typical attendees of an implementation meeting include but are not limited to research staff (clinical research coordinators, clinical research nurses, data coordinators, clinical research managers and regulatory compliance officers, PIs and sub-investigators), contract and budget analysts, clinical staff (clinic/unit nurse manager, nurse specialists, unit PCRM, clinic/unit staff RN), pharmacist, clinic and research lab personnel, hospital administration, financial counselors and pre-certification/pre-determination representatives.

The agenda may include, but is not limited to, the items below:

  • Key study personnel with contact information
  • Study overview including objectives, design and purpose
  • Participant eligibility and registration requirements
  • Study-specific tasks to be completed with timeline, feasibility and logistical requirements
  • Investigational product management, storage, ordering and shipping requirements
  • Required source documentation and examples of documentation tools
  • Specific nursing or ancillary staff requirements
  • Financial pre-determination or pre-certification considerations
  • Data elements collected and timeline requirements for data submission
  • Serious Adverse Event (SAE) reporting guidelines
  • Other processes or procedures that must be defined and implemented prior to enrolling study participants.

Study Visit Scheduling Templates

Recruitment Resources

Retention

At the time of obtaining informed consent, it is important to ensure that the potential participant understands what level of commitment is necessary to be involved in the research study in addition to the key elements of informed consent. The expectations of the number of visits, length of visits, tasks involved at each visit, duration of the overall study and potential costs should be clearly discussed with the potential participant prior to enrollment. If the trial is a randomized placebo or comparative controlled study design, then extra attention should be given to this discussion. All of these aspects of participating in a research study can dramatically impact the participant’s willingness or ability to commit to the full length of the study.

Study participation is completely voluntary and participants can withdraw from the study at any time. Providing consistent and informative visit reminders in the form of a letter and phone call can be helpful to participants and may positively contribute to participant retention. Also, writing protocols that allow flexibility in study visits to accommodate the busy schedules of participants may also yield a higher retention rate.

Clinic Appointment vs Research Appointment

Many studies at Ohio State recruit research participants from patients that are already scheduled for healthcare visits in the medical center or cancer center. If the study design is such that these visits can serve the dual purpose of study visit and doctor visits, then scheduling is relatively straightforward and involves coordinating with the clinical treatment team. Clinic and diagnostic testing appointments are scheduled in IHIS, the provider scheduling database. The research team can review the electronic medical record, for specific information on the visits scheduled. It is important to review the participant visits often, as they could be altered or canceled by someone else which may result in protocol compliance concerns or impact the anticipated activities for that day.  

For research appointments that need to be scheduled in the Ohio State hospital or clinics, independent of the patient’s medical appointments, most of the scheduling is done by the hospital schedulers or you might have a point person to ensure you have the correct staffing needed for the research visit. However, it is still the responsibility of the research staff to communicate the specifics of the protocol visit, including the timing of the visits scheduled, how long visits are expected to take, complete any paperwork necessary, obtain physician order for lab or special testing that needs to be performed at a given visit.

Many studies require that research visits take place in a location that is specifically equipped to carry out the research protocol. Space may be designed to administer specific computer questionnaires, to conduct interviews in a private setting, to be proximal to labs for obtaining and processing blood or other biological specimens or to medical equipment like research CT scans or MRI equipment that cannot be moved. Sometimes certain controlled environments or conditional experiences are part of the research visit. These visits will be arranged with the key research staff involved in the research visit and may not be formally scheduled in the medical center scheduling system. This can cause patients to get reminder calls about a research procedure that happens later in the day and it is separate from the time/location you had discussed for the consent procedure visit to take place. It is essential to send a research confirmation letter that lists the procedures to help clarify to the who, what when and where for the entire study visit.

Lab Review Documentation

When you receive lab reports your investigator will need to document that they have been reviewed. On any abnormal lab value the investigator must document if it is clinically significant. If it is documented as clinically significant then you will need to create an Adverse Event form. Sometimes the lab is related to other areas of the patient’s medical history so if it is abnormality, it can be documented as such. Great investigators write on the first batch of labs what the abnormal lab value correlates with in subject’s medical history (i.e. elevated glucose=subject is diabetic) so that reviewers can see that they reviewed all abnormalities seriously.  

Below is a link to a sticker you can attach to printed reports that quickly documents that the investigator has reviewed the labs and then have your investigator sign off on it.

Abnormal Lab Result Sticker (Word Document)

Scheduling Off-Site Research Visits

There are research studies that allow the visits to take place in the participant’s home or another neutral location that may be more convenient for the participant. Off-site study visits pose some additional challenges to the research staff in the form of feasibility and safety.

Before scheduling a home visit, research staff must assess if the visit tasks can be accomplished in the specific location. For example, is there a workspace sufficient to carry out lab draws and physical examinations, are there electrical outlets for medical equipment or laptop computers, etc. 

The distance away from the study center needs to be taken into consideration as many studies have a travel limit for outreach research staff. Distance can also cause some feasibility issues such as timeframe that blood specimens must be processed to maintain the integrity of the sample. Other things to consider include how the data will be transported to and from the home or off-site study visit. If laptops are used to transport data, they need to be encrypted to ensure HIPAA compliance.

Safety is also a necessary consideration when conducting home visits. When a member of the research team goes to an unfamiliar area to conduct a study visit, at least one other coworker should know that the appointment is occurring. The researcher should communicate with the research team immediately before and after the study visit occurs. The safety of the research staff should always be the primary consideration over the completion of a study visit outside the research study center and appropriate judgment should be utilized.

Fiscal Management/Invoicing

Grants that have a fixed effort will be invoiced by the Sponsored Program Office. Once your department appoints the specified effort or charges to the grant for approved supplies/patient care. If the study is fee for service the SPO will not have a way of knowing what has been completed for billing. If you work with the CTO/CCRM they will take care of invoicing. If you do not work with theCTO/CCRM the invoicing falls on the investigative team. Talk with your Sponsored Program Officer about the contract requirements and invoice templates.

Monitoring Accounts and Receivables

There are several groups depending on the funding type and department you are within that can assist with monitoring research accounts.  

  • The OSP is a great resource for managing and monitoring your research accounts
  • Grants Management Office (GMO), In the College of Medicine, helps with grants/awards that are not industry funded and they work more granular on the projects than the OSP
  • Other departments outside of College of Medicine have their own type of grants structure on their fiscal team but you would still have a sponsored program officer with OSP 
  • The Center for Clinical Research Management (CCRM) is used for most groups within the College of Medicine and they assist with industry sponsored and fee for service grants
  • The Clinical Trials Office (CTO) provides a centralized resource for the management of clinical trials in the Comprehensive Cancer Center 

It is important to understand the infrastructure and where to direct questions or concerns on projects. There are different management portals available, access depends on staffing roles/responsibilities. If additional access may aid with job responsibilities, first talk with the PI and once they approve, the staff member and PI should discuss with the department administrator.

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

Nationwide Children's Hospital logo

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

portrait of Jeff Grever wearing a red tie smiling for the camera

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
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