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TriNetX: From Cohort Identification to Enterprise Research Asset
TriNetX has been a popular research discovery tool at UC since 2016. There have been over 45,000 queries since it went live. Added functionality includes participation in the Research Network with scores of other institutions and a denominator of over 130 million subjects enabling Real World Evidence (RWE) studies. Features in development now include Privacy Protecting Record Linkage (PPRL), third-party claims data, death registry, Natural Language Processing (NLP), and OMOP data warehouse.
TriNetX From Cohort Identification to Enterprise Research Asset (PDF)
Cooperative Research - Reliance Agreements and External IRB & Updates to Reporting in MIDAS for Clinical Research
We will provide a reliance process overview and review and discuss relying on an External IRB including recent updates to the process for commercial IRBs and we will also address the criteria and updates regarding clinical research reporting in MIDAS.
Co-Op Research - Reliance Agreements and External IRB & Reporting in MIDAS for research (PDF)
Acquiring Remnant Tissue for Research Purposes
Acquiring Remnant Tissue for Research Purposes (PDF)
BMI RAP Subsystem Overview
Discover how the BMI RAP Subsystem bridges the gap between the UC IRB RAP system and the UC Health Clinical Trials website. With this tool, accessing and managing your study details becomes easier and more user-friendly. You can also easily publish or unpublish your study with just a few clicks.
Full BMI RAP Subsystem Overview (PDF)
Gender Equity in STEM: Can More Be Done?
The academic community continues to build upon the progress of recognizing the need for gender equity in STEM. However, the trajectory reveals that there is still an ongoing need to pursue these efforts. Exploration of the untapped potential towards equity is paramount, all while recognizing a few of the women pioneers who contributed to the advancement of science and medicine.
Gender Equity in STEM - Can More Be Done (PDF)
Office of Clinical Research Full Staff Open House
Given staff changes and many new members of the Office of Clinical Research (OCR) Team, we welcome you to join us for a special OCR Open House Lunch & Learn, to meet new OCR Team members, reacquaint yourself with longstanding OCR Team members, and learn the details of each of our roles within the OCR!
Office of Clinical Research Open House (PDF)
The Power BI UC Clinical Trials Contract Status Dashboard: A Hands on Walkthrough
In follow up to this month’s First Friday, please join the January 2024 CRP Lunch & Learn for a hands-on walkthrough of The Power BI UC Clinical Trials Contract Status Dashboard, our newly developed dashboard created to provide comprehensive data tracking of up-to-date information on study start-up progress, process bottlenecks, and further insights into UC/UCH clinical trial infrastructure.
The UC “Family” – Who We Are and How We Work Together.
UC, UCMC, UC Health, UCP, UCPC, West Chester, Drake – you hear these names and abbreviations on a daily basis, but do you know what they really mean? Are these all the same legal entity or are they separate organizations all together? Join Daniel Brummett, Executive Director of Finance and Operations for the College of Medicine and Chief Financial Officer for UC Physicians Inc. as he presents “The UC ‘Family’ – Who We Are and How We Work Together” . During the presentation you will learn about our various corporate entities, how they are structured from a legal and tax perspective, and the various and unique ways that we work together as part of the UC Family.
The UC Family Who We Are and How We Work Together (PDF)
Overview of the Center for Clinical & Translational Science & Training (CCTST)
Join us for an educational session describing the organization and roles of CCTST, with descriptions of innovative research programs and partnerships across institutions and communities addressing health disparities and the benefits of translational science. We will also address training and career support programs for translational scientists and explain how a learning health system for translational science addresses roadblocks in clinical and translational science.
Overview of the Center for Clinical & Translational Science & Training (CCTST) (PDF)
Lactation: Not Just a Women’s Issue
Despite strong evidence of the benefits of breastfeeding at the individual, societal and economic levels, there remains a paucity of policies, resources, and supports to promote and protect breastfeeding in the United States. This session identifies barriers and disparities in lactation and introduces practical innovations.
Lactation - Not Just a Women's Issue (PDF)
Advancing Gender Equity: Grassroots Efforts to Dean Allyship
Women make up half of the workforce across the US, including within academic medicine. Yet disparities exist. Come join us as 4 different groups from UC COM tell their stories of advocating for gender equity – from the departmental level to broader institutional initiatives.
Advancing Gender Equity Grassroots Efforts to Dean Allyship (PDF)
Decolonizing Methodologies: Reducing Bias in Research
The growing complexity of diversity coupled with the limited generalizability of biased research highlight the importance an intentional research agenda rooted in transparency, cultural humility, and collaboration. Decolonizing Methodologies: Reducing Bias in Research provides practical tools for understanding and applying the concept of decolonized research.
Decolonizing Methodologies Reducing Bias in Research (PDF)
A Clinical Trials Dashboard & The Stories It Can Tell
Comprehensive data tracking has long been a challenge for the folks managing clinical trials. As progress has continued on accurate documentation, the challenge of interpreting and communicating the information contained within our electronic data capture systems has become an increasingly relevant issue. We will explore a newly developed dashboard that has the power to provide up-to-date information on study start-up progress, process bottlenecks, and further insights into clinical trial infrastructure.
A Clinical Trials Dashboard & The Stories It Can Tell (PDF)
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Clinical Trial Agreement (CTA/Contract) and Informed Consent Form (ICF) Reviews: When and When Not to Edit
Join us for a refresher of the review process for agreement between Informed Consent Form (ICF) Subject Injury (SI) language and other components of the document, with the parameters set forth in the Clinical Trial Agreement (CTA) for clinical trials that involve more than minimal risk. This presentation will also discuss updates to this process regarding the OCR online CTA submission system.
ICF-CTA Reviews (PDF)
Best Practices: Communication between study teams and clinical care staff
Join us for a discussion of best practices regarding communications between clinical research study teams and clinical care staff for best outcomes.
Best Practices Communication between study teams and clinical care staff (PDF)
Investigator Initiated Trials: Best Practices and Lessons Learned
Please join the UC Cancer Center Clinical Trials Office staff for an informative presentation on Investigator Initiated Trials (IITs). You will learn how to identify the resources needed to conduct an IIT, how to write an effective research protocol, as well as tips for navigating the study start-up process. UCCC CTO staff will share their lessons learned and best practices for effectively opening and running IITs.
Investigator Initiated Trials Full Presentation (PDF)
The Linking of Studies: Keys of the System
An exploration of the mechanisms behind the linking of patients, visits, and orders to research studies in Epic, followed by a discussion on how Epic can be utilized to improve processes and billing compliance. This presentation will be a peek at the side of Epic Research that most study teams don’t get to see.
From Blood and Guts To Bits and Bytes: Clinical Research Informatics Using TriNetX
FDA Audits: Preparation, Lessons Learned, and FAQ Join us for a discussion of FDA Audits, presented by the UC Neurology Department and the UC IRB.
The Illustrative Female: Mary Maciel and Other Women in 20th Century Medical Illustration
Though the number of female medical and health professionals rose gradually throughout the early twentieth century, one area of the medical field in which women not only worked, but thrived, was that of medical illustration. Of the 60 charter members of the Association of Medical Illustrators in 1946, forty were women. Though many of these women were trained by the famous Max Brodel at Johns Hopkins, these female artists very soon began to exercise leadership in the field for many years to come. In Cincinnati, this national pattern was personified in Mary Maciel. Like many of her female contemporaries, she was trained by Brodel at Johns Hopkins. It was Maciel however who began the medical illustration department here at the University of Cincinnati College of Medicine and served as its chair for over twenty years. This presentation will share insights primarily into the life and work of Mary Maciel, while at the same time look at the work of several other women whose skill at depicting human anatomy made them invaluable to the medical profession they served.
Cancelled
Maternal Mortality and Racial Disparities: A Silent Epidemic Recognized in Our Community
Please join us for this presentation bringing awareness to obstetrical patients requiring higher levels of care, including critical care, while acknowledging and discussing ongoing racial disparities relating to maternal morbidity and mortality both nationally and at a local level. Work is being done to bridge bias at the bedside to the gap in research pertaining to pregnant and birthing women, especially those from marginalized or lower socioeconomic patient populations.
NIH / clinicaltrials.gov Mandates: Required registration of NIH funded studies and posting of study results.
As of October 1st, 2021, the NIH mandates that all clinical trials with any NIH funding register on clinicaltrials.gov. Annual updates of records as well as posting study results are required. Letters of non-compliance are being issued when updates are not complete for each individual applicable study. Failure to comply jeopardizes funding to the PI and the institution. Please join us for a discussion of this important requirement and a “How To” walk through of the process.
Exception From Informed Consent (EFIC): Trauma Research
Join us for a discussion on Exception from Informed Consent (EFIC) trials for emergency research, specific to Trauma Surgery at UC. There are many EFIC trials that are actively enrolling in our community, and it is important to not only talk about the trials themselves, but explain what scenarios allow them to be conducted. We must also consider what steps have been taken to inform a massive community, who may take part.
EFIC Trauma Research (PDF)
Electronic Pathways: HIPAA, Texting, Emails
Join Janelle Allen for the October First Friday Seminar Series to weave through the in's and out's of communication pathways in clinical research. Phone, text, email, newsletter, social media, etc. so many ways to connect with participants... but are we truly connecting, effectively, and through properly regulated and safe pathways. Come to review and collectively dialogue on the dissemination and transfer of information.
Electronic Pathways HIPAA, Texting, Emails (PDF)
The Elephant, the Astronaut, and Shadows of the Cincinnati General Hospital: Curiosities Found in Four Decades at the University of Cincinnati.
Join us for an informal session revealing the stories behind some of the UC's and the University of Cincinnati Medical Center's familiar names and locations, as well as some others that may be less familiar, but are hiding in plain sight. The Elephant, the Astronaut, and Shadows of the Cincinnati General Hospital: Curiosities Found in Four Decades at the University of Cincinnati. (PDF)
Unlocking the Power of eConsent in REDCap
Join us for an informative session where you will gain a deep understanding of eConsent in REDCap, covering its fundamental aspects. Discover the seamless integration of eConsent tools in REDCap and learn how they enable researchers to deliver a robust and valid electronic Consent experience to research participants, while also exploring the introduction to REDCap access and new project request processes. Unlocking the Power of eConsent in REDCap (PDF)
Team Science: Understanding Communication Styles
Innovative organizations are built by high functioning, inclusive teams with the ability to communicate skillfully. Excellent communication skills enhance self-awareness, awareness of others and team function. Teams that communicate effectively complete projects in a quicker and more efficient amount of time than others. Effective communication also allows team members to understand their roles and the roles of others on the team. We will explore different communication styles through the colors assessment and how each interacts in the workplace successfully. Team Science: Understanding Communication Styles. (PDF)
High Enroll: Updates, New Features, Demo, Q&A
Poor patient recruitment remains the most significant barrier to clinical research. High Enroll is a “First of its Kind” platform designed to broaden awareness of your research portfolio amongst healthcare providers and patients. The easy-to-use platform helps manage trial information as it flows from the sponsor, through IRB approval, to patients via multiple marketing channels. Please join us for an overview of this exciting tool for clinical research recruitment. High Enroll : Updates, New Features, Demo, Q&A (PDF)
Women's Herstory Month Presentations: Discrimination and D.E.&I.: Two Sides of Social Determinants of Health for Women
Discrimination is a significant social determinant of health and women can be disproportionately impacted. Illegal discrimination can impact women’s access to healthcare, health outcomes, and overall well-being. In contrast, promoting diversity, equity, and inclusion initiatives can promote health equity by addressing social determinants of health, reducing implicit bias, promoting diversity in the healthcare workforce, and improving access to culturally competent healthcare for women. Discrimination and DE&I:Two Sides of Social Determinants ofHealth for Women (PDF)
Black History Month Presentations: Black Doctors and the Jim Crow Infrastructure of Cincinnati
Though Ohio was a free state, Cincinnati was an upsouth city that was (and still is) deeply segregated. Black (and white) life was profoundly punctuated by quotidian practices of Jim Crow. Racism, not race, produced and intensified health disparities between Cincinnati’s Black and white citizens. Cincinnati Black doctors, like Cincinnati Black educators, faced an unfortunate dilemma: embrace the progressive era cultural pluralist vision that co-existed with separate but “equal” with hopes of providing the necessary care the community needed OR follow the lead of integrationists like the NAACP and the National Medical Association who were unwavering in their declaration to dismantle a segregated medical infrastructure that was inherently unequal, under-funded, and under-resourced. This lecture details the history of Cincinnati Black doctors, their advocacy and their dilemma on how best to advance the Cincinnati Black community’s health and collective interest. Black Doctors and the Jim Crow Health Infrastructure of Cincinnati (PDF)
Communication, Conflict, and Leadership: A Team Science Approach
This workshop will introduce concepts of team science around leading and managing high functioning teams for Clinical Research Professionals (CRPs). We will focus our discussion on management versus leadership styles, communication best practices, and conflict management strategies in teams. Communication, Conflict and Leadership: A Team Science Approach (PDF)
Exploring Recruitment Resources: StudyKik, TrialFacts, and ResearchMatch
Recruitment obstacles- beware! An overview of three powerful recruitment resources available for your study’s recruitment needs- StudyKIK, Trialfacts, and ResearchMatch. Tune in to learn more about each recruitment tool, their unique services, and the benefits they can bring to your recruitment plan. Exploring Recruitment Resources (PDF)
Health Literacy for Clinical Research
Health literacy is the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions. Low health literacy is more prevalent among older adults, minority populations, and those who have low socioeconomic status. This presentation will address the importance of relationship-centered communications in health literacy for clinical research. Tune in to learn more! Health Literacy for Clinical Research (PDF)
Unconscious Bias and Its Impact in the Workplace
Often, well-meaning people may negatively impact their working environment and relationships due to their unconscious biases. While having bias is normal, unconscious bias is where our greatest opportunity for personal growth and development lives. This presentation explores where our biases come from, how they show up in our workplaces, and practical advice on how to identify and manage them. Unconscious Bias and its impact in the Workplace (PDF)
An Update on Conducting Research at the VA: It is Easier Than You Think!
A presentation on the ins and outs of conducting research at the VA, in the animal, bench, and clinical realms. There have been many changes in regulations and many of the restrictions that limited collaboration have been removed. An exploration of how you can increase participation in your studies by including Veterans! An Update on Conducting Research at the VA (PDF)
Gender Diversity & Inclusion: Microaggressions in the Workplace Part I
The OCR is celebrated Women’s History Month with a two part presentation. Part one, the March 2022 First Friday, our presenter Dr. Jamilah Hackworth, EdD led a discussion addressing various types of microaggressions in and out of the workplace, and identifying one’s own micro-aggressive and/or biased tendencies, and how to manage them. Gender Diversity & Inclusion (PDF)
The Training and Roles of Infectious Disease Pharmacists
Infectious disease (ID) pharmacists are specialists in antimicrobial pharmacotherapy while often having substantial knowledge related to clinical microbiology and the management of infectious processes. The training path is unique for each pharmacist who specializes in infectious disease, and these pharmacists may use their training to work in a variety of settings such as in clinical health systems, ambulatory care, academia, or research. This presentation describes ID pharmacist training and typical practice roles from the perspective of a current ID pharmacist. The Training and Roles of Infectious Disease Pharmacists (PDF)
Services and tools that Support Translational Research at the Department of Biomedical Informatics
An overview to become familiar with the various tools, services and capabilities provided by the Department of Biomedical Informatics at the UC College of Medicine, where you’ll gain a high-level understanding of data types, de-identification, the Privacy Rule, and an understand of the differences between research and QA/QI, as well as where the lines are often blurred. Services and tools that Support Translational Research (PDF)
The Value of Engagement: Seeing Patients/Caregivers as Critical Research Experts
Research has great potential to impact people’s lives IF participating patients and their caregivers understand their roles in its success. If CRPs engage their participants and help them see themselves as expert stakeholders, their study’s recruitment and retention will benefit. The Value of Engagement (PDF)
IDS (Investigational Pharmacy) – A great drug interaction!
A look into the world of Investigational Drug Services and its relationship to other research areas. Discover the innovations propelling the growth of IDS and refresh pharmacy tips and tricks for IDS requests.
EpicCare Link
A review and discussion regarding EpicCare Link workflow and management.
Kuali Overview, Tutorial, and Q&A for New Users
The OCR move from UCH to UC has impacted clinical research workflows. One of the changes is how contracts are managed using the Kuali system. An overview and review of the Kuali Contract Management system for sponsored research and a tutorial for new and existing users in need of a refresher.
Education and Career Development: Formal Education at UC
Educational opportunities at University of Cincinnati. Topics include how to activate tuition remission for UC employees, degrees and certifications of interest to Clinical Research Professionals (CRPs), and addressing challenges to completing formal educational requirements.
Effective Corrective and Preventive Action Plans
A discussion of the importance of root-cause analysis, process development, and error-proofing in creating effective corrective and preventative action plans. Also a discussion of examples of errors in the research process to facilitate discussion of the presentation's key concepts.
Clinical Research Finance, Accounting, Post-Award, and Invoicing Town Hall
The second special CRP Lunch & Learn Town Hall session, with a focus on Clinical Research Finance, Accounting, Post-Award management, and Invoicing
Industry Sponsored Research Contract submissions in the REDCap System
The OCR move from UCH to UC has impacted clinical research workflows. A major change is how new contracts for industry sponsored research are submitted and managed. Please join us for an overview and review of the REDCap Industry Sponsored Contracts Submission System.
ClinCard Participant Payment Solution
UC and UC Health’s preferred participant payment solution for clinical trials- ClinCard! ClinCard is the industry standard in participant payment automation that eliminates administrative burdens that can distract from the pursuit of research by allowing you to pay your participants with a few short clicks in the payment website. ClinCard allows participants to receive their payments in a quick and easy way while providing a full audit history, for the coordinator’s benefit.
Gender Diversity & Inclusion: Microaggressions in the Workplace Part II
A follow up to the March 2022 First Friday presentation, a workshop with breakout discussions where we will learn micro-interventions and how to use them in response to microaggressions, and how to become an abolitionist in identifying and targeting microaggressions in and out of the workplace.
March OCR CRP First Friday and Lunch & Learn (PDF)
Radiology Research Needs Assessment Submission System
In ongoing efforts to improve Clinical Research Workflows, Investigational Imaging Services (IIS) has implemented a new submission system for the assessment of your study’s imaging needs. Join us for a walk-through of the submission system and Q&A session on its use.
May Lunch & Learn (PDF)
The Immortal Life of Henrietta Lacks
Highlights of the profound impact the HeLa Cell line on the advancement of science and research, and how this cell line was established and used for years without the consent of Henrietta Lacks or her family. Focusing on a history of exploitation of minority groups and Black people for the sake of medical research, the consequences, and efforts to end racial health inequities.
Tips for Maximizing Your Virtual Work Experience
In recognition of the one year mark of the work from home experience, or a hybrid model of work from home and onsite for many Clinical Research Professionals, this talk discussed tips and solutions for maximizing the virtual work experience.
Budgeting for Federally Funded Research and Clinical Trials
An overview of budgeting for federally funded research with an emphasis on budgeting specifically for federally funded human subjects clinical trials. Also tips and solutions from subject matter experts, on how best to execute the budgeting process for federally funded research.
Team Science: Communication, the Cornerstone of Successful Teams
An overview of the basic principles of Team Science and the value of working in teams, introducing the research community to personal styles of communication and how they impact working relationships and team functioning. Tools and strategies for navigating difficult conversations using the “Crucial Conversations” model.
Recruitment and Retention During a Pandemic: The experiences of the CTN0080 MOMs study
The Covid-19 pandemic posed many challenges to Clinical Research, from subject recruitment to how study visits were conducted. A discussion of the different strategies and methods employed to keep the CTN0080 MOMs study running during the Covid-19 pandemic, including recruitment and retention tactics, as well as protocol changes due to the Covid-19 pandemic.
High Enroll Clinical Research Recruitment Services
Poor patient recruitment is the largest operational and cost barrier to clinical research for industries that support research conduct, organizations that recruit the research patients, and investigators that design and take responsibility for studies. By combining an easy-to-use platform with an intuitive mobile application, High Enroll makes sharing and coordinating recruiting efforts easier than ever before. An overview of High Enroll, an exciting tool for clinical research recruitment.
Biospecimen Collection and Handling for Clinical Research
Biorepositories, also known as Biobanks or Tissue Banks, are entities that procure, process, and store human biological samples for future use, and are critical to enabling research leading to better understanding of the molecular processes of human disease.An overview of the basics of Biobanking, proper handling and types of specimens, legal and ethical concerns, and how the University of Cincinnati Biorepository may be a resource for your research.
Ignaz Semmelweis and Childbed Fever
Science is the process of trying to understand how things work. Ignaz Semmelweis did not have our modern statistical tools when he joined the faculty of the First Ward of the maternity clinic of the Vienna General Hospital in July,1846. He was very concerned because 17% of women in the maternity clinic had died after delivery in the month prior to his hire. A review of how Semmelweis collected data to understand what was killing these women, and how he tried to change hospital processes and culture.
Understanding and Utilizing Umbrella Protocols
Umbrella Protocols allow for multiple, similar research projects to be conducted under one IRB application. This framework is particularly useful in the context of chart review research, such that individual investigators can be added to an umbrella protocol, rather than obtaining independent IRB approval. An overview of how various departments use umbrella protocols, and the regulatory requirements to keep in mind to make yours successful!
UC Conflict of Interest: COI Overview, FAQs, and Updates
An overview of the UC Conflict of Interest (COI) process and updates to the COI workflow in our institutional e-Regulatory platform Complion. Frequently asked questions will be addressed, and there will be a Q&A session.
Epic Recruitment tools
A detailed overview of the various research participant recruitment tools available in Epic. This presentation also discusses how to decide on the best recruitment tool for each study, the process of submitting requests for Epic recruitment tools, as well as best practices and tips.
Research Communication with Clinical Care Teams:
A discussion of best practices and proven methods of research study team communication and collaboration with clinical care teams and departments for the successful execution of research studies, visits, and procedures, and increased research study awareness among clinical staff.
ResearchMatch and other Recruitment Services
An overview of ResearchMatch, a free and secure online recruitment tool that helps match willing volunteers with eligible studies at institutions nationwide. Also a live demonstration focusing on best practices to enhance your ResearchMatch experience and other recruitment services offered.
UC Health Clinical Research Billing: Best Practices and FAQs
An overview of common research billing challenges, addressing different points in the lifespan of research billing, including Coverage Analysis, RedCap study submission, and Research Encounter Form submission. This presentation also touched on the future of research billing as well as best practices.
UC Health Investigational Pharmacy (IDS): Overview, Updates, Best Practices and FAQs
An overview of best practices and frequently asked questions when it comes to engaging Investigational Pharmacy (IDS) for your studies. This IDS refresher presentation also includes updates to IDS procedures, as well as a refresher/overview of Beacon Builds.
Introduction to the updated WCG IRB Connexus™ Portal - General Training and Q&A
An introduction to new WGC IRB Connexus Portal. The new Connexus portal was effective July 1st, 2021, and the old Connexus portal will no longer be used. This training and overview covered new portal features and workflow, updated all with users in mind. The target audience for this presentation was CRPs who use WCG IRB as their IRB of record and use Connexus to manage regulatory for their studies.
Clinical Research Town Hall Discussion
Clinical research leadership on hand to moderate and address questions regarding the Office of Clinical Research move from UC Health to University of Cincinnati College of Medicine, with introductions to key contacts, roles of new departments, and where to reach out.
The Budgeting Process for Industry Sponsored Clinical Trials: Overview and Updates
A review of the clinical trials budgeting process. Including updates to the process, as well as tips and best practices regarding setting up budgeting for your studies.
The Consent Process for Central IRBs
Please join us and our speaker Kareemah Mills of the UC HRPP for an overview of reliance on commercial IRBs, including currently executed agreements, number of studies, requirements for reliance determinations, completing the cover page for external IRBs, processes for changes to informed consent language, and approval release for studies housed at Advarra IRB and the WCG Group IRB.
General Data Protection Regulation (GDPR): The European equivalent of HIPAA
Please join us and our speaker, Lorren Ratley of the UC Privacy Office, for an overview of General Data Protection Regulation (GDPR), and how it affects clinical research in the United States. Tune in to learn more!
General Clinical Research Town Hall
OCR Leadership and other Special Guest Clinical Research Leadership with focus on general questions and topics related to the OCR move to UC.