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

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.

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Funding Programs

Gain exclusive access to internal grant funding programs.

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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.

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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
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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 advance health equity by placing established clinical trials infrastructure in FQHC primary care settings to serve patients across Ohio who face a high burden of health and remain underrepresented in research.

Our Partnership with OPCIN
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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

The Business of Science 2024

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

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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.

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