SCORE Half-Day Seminar: A Minds-On Practice

The Study Coordinators Organization for Research & Education (SCORE) recently held its 8th annual Half-Day Seminar. This year, the seminar included lectures on self-determination theory, standard operating procedures, and mindful practice, and also focused on root cause analysis, a method of reviewing adverse events that occur in clinical research in order to prevent recurrence.

SCORE, which is part of the Clinical and Translational Science Institute, provides support and networking opportunities for research coordinators and staff across the University of Rochester. With recent changes in Food and Drug Administration guidelines for investigation of adverse events in clinical trials, some of the burden of root cause analysis has fallen to study coordinators and research nurses.

Multi-Cultural Office Staff Sitting Having Meeting TogetherThat is why the Seminar Planning Committee, according to Nancy Needler, Manager, CTSI Research Coordinator Program decided to include a hands-on and “minds-on” root cause analysis practice in breakout sessions this year – a first for the SCORE Half-Day Seminar.

The hands-on practice was kicked off with a lecture on root cause analysis by Michael Leonard M.D. M.S., associate professor of Pediatrics and associate chief quality officer for UR Medicine. During his lecture, Leonard and a group of actors introduced a hypothetical scenario of an adverse event in clinical research. In the scenario, a teenaged participant in a clinical trial for a depression medication was sent to the emergency department after overdosing on the study drug.

According to Needler, key information was purposefully left out of the scenario introduction, “because you never have all of the information from an event in normal life situations.”

Seminar participants had the opportunity to gather more information by asking the actors questions prior to breaking into groups for discussions with trained facilitators. The seminar participants divided into six groups to review the facts and find areas or policies that could be changed to prevent this adverse event from happening again.

“What I thought was wonderful from all of the teams,” says Needler, “was that none said ‘it was so-and-so’s fault’. They all examined the process; not the person.”

That is key in root cause analysis. The goal is to identify the sources of error in a systematic process and to develop approaches that address the root of the issue.  The seminar’s scenario reflects the reality that research teams plan and manage study activities with the utmost focus on ensuring participant safety and maintaining data integrity.

The presentation that followed the root cause analysis activity was an orientation to the development of Standard Operating Procedures (SOPs), which are a set detailed instructions for each process used in a clinical study. Root cause analysis often leads to development or modification of SOPs in order to prevent future adverse effects or breaches of protocol.

Closing the Half-Day, attendees participated in a mindful exercise guided by Ronald Epstein MD, professor of Family Medicine, Psychiatry and Oncology at URMC.   Attendees were introduced to the concepts of mindfulness, to promote resilience and well-being in the workplace.

The seminar was well-attended with 123 participants from 9 institutions, with over 30 University of Rochester departments represented.

CTSI Now Offers Advanced Certificate in Regulatory Science

FDA food and drug administration approval health pharmacy certification

The CTSI, in partnership with the Department of Public Health Sciences, is rolling out a new advanced certificate in regulatory science for graduate students, postdocs, and researchers from a broad range of fields. The program is just one of several efforts by the CTSI to advance regulatory science and promote student and trainee interest in learning how new drugs and devices are developed and ultimately reviewed by the Food and Drug Administration (FDA).

The NYS-approved certificate, which is a graduate credential, requires 6 courses (totaling 13 credits) covering experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy. Students will also obtain at least 3 additional credits in an area of their choice, including options such as pharmacology, epidemiology, clinical trials, drug discovery, or scientific communication.

Beyond the course work, the certificate program offers mentorship and assistance in finding internships and shadowing experiences for regulatory science careers. Additionally, certificate students will participate in the annual “America’s Got Regulatory Science Talent” competition. Each year, the winner of the competition is given the opportunity to present their proposal to scientists and leaders at the FDA.

According to Scott Steele, Ph.D., associate professor of Public Health Sciences and program director for the certificate, “that exposure can give students a unique opportunity to engage leaders in this field and an advantage in identifying career paths – especially in industry or government”.

Steele believes the new regulatory science certificate program can help students with a broad range of career goals. Understanding the opportunities and challenges with medical product development and the FDA regulatory process is extremely valuable whether students plan to stay in academia or branch out into industry, government or other sectors.  This could include careers in research, policy, regulatory review, communications, program management and law.

Ultimately, the goal of regulatory science is to make the process of developing and approving new drugs and medical devices more efficient and ensuring that new, life-improving therapies can be properly and thoroughly evaluated as quickly as possible. Programs like the CTSI’s regulatory science certificate help by training scientists in the science, regulatory and policy issues involved in medical product development, creating a pipeline to the FDA, industry and other sectors.  This helps improve the efficiency and effectiveness of the translational research process by reducing the “ramp up time” for professionals in industry, academia and FDA and creating a scientifically trained workforce that is proficient in the science and policy issues that underlay the medical product development and approval process.

The certificate program applications are currently being processed for Spring 2017 but students, post-doctoral fellows, researchers and faculty can begin registering for required coursework this fall. The fall registration period for matriculated students at the University of Rochester School of Medicine and Dentistry opens July 1.

For more information and a full list of certificate requirements, click here.

Congratulations, Graduates!

MD Grads
This past weekend (May 13th and 14th) students from graduate, medical, and nursing programs at the University of Rochester School of Medicine and Dentistry and School of Nursing moved their tassels from right to left, marking an important milestone in their careers.  Commencement ceremonies honored the achievements and hard work of our many graduates through the weekend.

The CTSI would like to congratulate all of the University’s recent grads with special recognition for several medical school graduates who participated in the CTSI’s Academic Research Track and those supported by the CTSI during their MD/PhD program.

Josef Bartels, M.D.
Project Title: The Context, Structure, and Function of Silence in Doctor-Patient Communication
Mentor: Ronald Epstein, MD

Laura Fornarola, M.D., Ph.D.
Project Title: Determining the role of the proryl isomerase Pin1 in neuronal programmed cell death
Mentor: Robert Freeman, PhD

Michael Geary, M.D.
Project Title: Modulation of the prostanoid receptor EP4 to reduce scarring during flexor tendon healing
Mentor: Regis O’Keefe, PhD

Natalia Golub, M.D., Ph.D. 
Project Title: Longitudinal Health Outcomes in Former Refugees
Mentor: Diana Fernandez, MD, MPH, PhD

David Paul Grad HugTrevor Hansen, M.D.
Project Title: Thy1 Expression as a Marker and Therapeutic Target for Scar Formation in Capsular Constracture following Reconstruction Mammoplasty
Mentor: Richard Phipps, PhD

Kelly Makino. M.D.
Project Title: Advance Care Planning in Early Dementia Study
Mentor: Anton Porsteinsson, MD

Kevin Makino, M.D., Ph.D. 
Project Title: An Exploration of the Role of Public Health Insurance in Moderating the Effects of Low Family Income on Children’s Educational Success
Mentor: Bruce Friedman, PhD

David Paul, M.D.
Project Title: Using DTI to measure changes in occipital lobe white matter after decompression of the optic chiasm
Mentors: Brad Mahon, MD and Edward Vates, MD, PhD

Kyle Rodenbach, M.D. 
Project Title: Crystatin-C-based renal reserve in children with history of hemolytic uremic syndrome-associated acute kidney injury
Mentor: George Schwartz, MD

Lauren Roussel, M.D. 
Project Title: Evaluating Upper Extremity Function Following Mastectomy in Reconstructed and Non-Reconstructed Women with Breast Cancer

Helen Wei, M.D., Ph.D.
Project Title: Astrocyte regulation of the cerebral microcirculation
Mentors: Maiken Nedergaard, MD, DM.Sc. & Edward Vates, MD, PhDRodenbach Grad

For more photos, visit the University of Rochester Commencement 2016 webpage.

Photo credit to University photos / J. Adam Fenster

Apply Now: Certificate of Advanced Study in Biomedical Data Science

The Clinical and Translational Science Institute and Department of Public Health Sciences are datascience_1accepting applications for the 2016 Summer cohort of the Certificate of Advanced Study in Biomedical Data Science (CAS-BDS).

Enrollment is open and classes begin on Monday, June 27.

The program, centered around a two-semester analytic project, prepares researchers to conduct “big data” analytics for health services, clinical, and public health research. This program prepares researchers for careers in data analytics, data wrangling, and clinical and health services research using large complex datasets.

“We consulted with people from industry and in academia, and looked at the state-of-the-art in terms of what people were teaching,” said Tim Dye, Ph.D., director of biomedical informatics at the CTSI. “We created this Certificate specifically to fit with all that.”

The CAS-BDS is a stackable data analytic credential for researchers and analysts with biomedical, computer science, statistical, or health service backgrounds. The curriculum draws on a range of courses that cover the fundamentals of disease biology, health care systems, and big data management and analytics.

Coursework begins with an intensive summer session that will give researchers a solid background in data science, data management, human biology, and team science. About a half dozen courses are new, having been created specifically for CAS-BDS.

“It’s pretty intense — starting with a summer Boot Camp that familiarizes everyone with the basics,” said Dye, who worked with faculty in the Institute for Data Science and elsewhere to make sure the Certificate complements other university data science offerings. “But we thought all these topics were required to have a good foundation in data science applied to the biomedical area.”

Several possibilities exist for the two-semester mentored project, which can have a basis in basic science, clinical work, health services, population health, or other fields. Projects will include attention to specific aim formulation, background, analytic plan development, database creation, data analysis, and reporting.

For more information on the CAS-BDS, visit or contact

Rigor and reproducibility: What you need to know

Starting in 2012, Brian Nosek, Ph.D., of the University of Virginia, began a project that would attempt to reproduce the results of 100 psychology studies that had been published in three scientific journals. Enlisting the help of several hundred colleagues across the country, the scientists simply re-ran the studies described in the journals to see how many of them would match up to the results of the original publications.RRimage

Only 39 of them did.

Nosek’s findings, published in the journal Nature in 2015, are among the reasons that the National Institutes of Health are placing an added emphasis on rigor and reproducibility.

The former begets the latter – or so the hope is – and that’s why new requirements are popping up on grant applications to ensure that researchers are using rigorous, robust methodology that has been carefully planned out.

Among the changes to NIH grants:

  • The addition of a “scientific premise” section that discusses the strengths and weaknesses of previous research. Researchers must show how their study is going to fill in some areas of weakness or expand on areas of strength.
  • Added emphasis on the research approach, including biostatistical methods, inclusion and exclusion criteria, and diversity in study subjects.
  • Requirements that researchers authenticate key biological or chemical resources, to protect against false findings caused by cross contamination.

“The NIH really wants to make sure that the methods you’re using have been planned out correctly,” said Carrie Dykes, Ph.D., research engagement specialist at the CTSI.

Fortunately, the Research Help Desk is available to answer questions and provide expertise about the grant changes. View a presentation detailing the new requirements or email for more information.

Nature also recently posted an article on the subject here.

TBS Ph.D. candidate Molly Jaynes appears on WXXI’s Connections

Molly Jaynes, who is in her fourth year of the Translational Biomedical Science Ph.D. program, was recently on WXXI Connections with Evan Dawson, discussing her research and a possible cure for focal dystonia. Jaynes was joined by her mentor, Jonathan Mink, M.D., Ph.D., and were speaking in advance of Jaynes’s Oct. 29 lecture at the Rochester Museum and Science Center. Catch up on her interview here, or check out the video below to see more about what she has been working on!

Scholar Spotlight: Madeline Beach

Madeline Beach is currently working towards an M.S. in Applied Statistics through the Center for Quality and Applied Statistics at Rochester Institute of Technology. She’s then hoping to continue on to a Ph.D. in Biostatistics or Statistics, and is interested in working in the field of mental health, with a focus on quality of life and depression among the Deaf and geriatric populations. She is one of three scholars currently in the program, which is a joint venture between the University of Rochester and Rochester Institute of Technology — thanks to the folks at RIT for allowing us to use their video! Learn more at

If you’d like to see your research featured in the CTSI blog, email

Public Health Sciences offers five new Advanced Certificates

The Department of Public Health Sciences is now offering five Advanced Certificate programs covering a range of public health issues.JimDolan

“These could be a good fit for working professionals who want to acquire these sort of skills to help them in their current job who don’t have the time or inclination to get a full degree,” said James G. Dolan, associate professor of Public Health Sciences. “These smaller-sized versions of our degree programs that are easier, more accessible, and perhaps more appropriate for a lot of people.”

Though certificate applications are closed for this fall, those wanting to get a jump can still take non-matriculated classes and then enroll in Spring 2016, which will allow them to apply the credits retroactively. The five certificates:

Analytic epidemiology (12 credits)

-Provides a practical understanding of quantitative research methods through a selection of epidemiology courses.

Clinical research methods (12 credits)

-Designed to give a broad overview of both quantitative and qualitative research.

Trial-based clinical research (12 credits)

-Designed for those who want to learn more about conducting controlled trials.

Health services research (12 credits)

-Designed for those looking to navigate the changing health care landscape.

Public health (15 credits)

-A less intensive version of the Master’s in Public Health; designed for people who are interested in sitting for the American Board of Public Health certification exam.

Learn more about the programs, or email for more information.

The Department of Public Health Sciences has also partnered with the CTSI on an Advanced Certificate of Biomedical Informatics. Learn more.

CTSI Welcomes New Year Out Trainees


(L. Erika Snow, R. Leigh Sundem)

The CTSI Year Out Program for Medical Students welcomed two new trainees on July 1st. The CTSI supports medical students interested in a year-out experience of mentored research in clinical or translational research; most students enter through the Academic Research Track (ART) program.

Erika Snow will be working with Dr. Scott McIntosh on a project titled “The Role of E-cigarettes as a Barrier to Smoking Cessation.” Dr. McIntosh’s research focuses on stop-smoking interventions with various populations and the training of physicians and other medical professionals in guideline-based nicotine dependence interventions. Erika will also pursue a Masters in Public Health during her year out.

Leigh Sundem will be working with Dr. John Elfar on a project titled “Erythropoietin for Compression Neuropathy: Preclinical Efficacy and Cellular Site of Action.” Dr. Elfar specializes in the treatment of sports and hand, wrist, elbow, and shoulder problems. His clinical interests include all aspects of upper extremity trauma and reconstruction as well as injuries in the competitive and recreational athlete.

Click here to view all previous CTSI trainees.

For more information on CTSI education programs like the Year Out program , contact Katie Libby, CTSI Education Program Manager, at


Winner of URMC’s “America’s Got Regulatory Science Talent” competition presents idea to FDA

In some patients, acute myeloid leukemia strikes hard and fast. And in one subset of these individuals, researchers now know why: a mutation in their DNA which results in a more aggressive path for the disease.

With this knowledge, providers can potentially screen for this mutation, allowing them to treat the patients more intensively. The discovery was another success in the world of genome sequencing, which is being studied more and more frequently as scientists and physicians learn more about how variations in a person’s DNA can affect how they respond to disease and medication.  This approach is often referred to as personalized or precision medicine.

From left to right: Scott Steele, Ph.D.; Corey Hoffman; Stephen Ostroff, M.D.; Joan Adamo, Ph.D.

From left to right: Scott Steele, Ph.D.; Corey Hoffman; Stephen Ostroff, M.D.; Joan Adamo, Ph.D.

To further advance personalized medicine, Corey Hoffman wants all of the genomic data from trials utilizing genome sequencing to be accessible in the same database. This will allow researchers and scientists to easily expand on previous work, identifying and using these genetic markers to speed drug development and aid in drug safety by targeting specific populations likely to respond to a given treatment.  Hoffman’s idea won URMC’s “America’s Got Regulatory Science Talent” competition in February, and earned him a trip to Maryland, where he presented his database idea at the FDA’s 2015 Office of Regulatory Science and Innovation Science Symposium.

“There are two potential outcomes that I could see,” said Hoffman, a predoctoral student at URMC, told CTSI Stories in March. “The first is that you could screen a patient’s genome so that when patients do respond well in a trial, maybe there’s a genetic element they share.

“Secondly, certain individuals don’t respond well to certain drugs because of how their body metabolizes the drugs… so you could screen people for mutations in their CYP gene to give indications for drug response, and who is and isn’t a good candidate for a certain drug.”

Hoffman, who was joined at the conference by University of Rochester’s Scott Steele, Ph.D., and Joan Adamo, Ph.D., presented his idea to the FDA’s Acting Commissioner, Stephen Ostroff, M.D. and other leaders and staff at the FDA.