Research is becoming progressively digital, mobile, and rapid-paced, making it extremely important to streamline and digitize processes.

Managing paper documents for regulated processes or lab protocols takes up space, creates inefficiencies, and leaves room for human error.

The University has a digital documentation solution, called OnBase, which provides a central repository for better management and control of procedures, protocols, and other departmental or regulated documentation.

OnBase is built for groups who would like to decrease their paper based files and increase compliance to regulations – be it to meet Food and Drug Administration regulations, like Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), or Good Laboratory Practices (GLP), or ISO clean room standards.

This electronic file management system can help teams:

• track and revise standard operating procedures (SOPs)
• distribute and trace required staff training documentation
• ditch old fireproof cabinets for searchable databases
• streamline some of the cumbersome documentation processes

The Medical Center’s Upstate Stem Cell cGMP Facility recently implemented OnBase to digitize and streamline processes mandated by the Food and Drug Administration (FDA).

“Our facility is FDA-compliant and going paperless. We still work as a team in our documentation review but now it’s within the OnBase Workflow,” said Luisa Caetano-Davies, principal scientist and facility manager at Upstate Stem Cell cGMP. “Document review dates are now difficult to miss, documents are easy to find, and once approved, they cannot be edited. Above all our documentation is easier to manage and is catastrophe-proof.”

Teams can author and edit documents within OnBase or outside of the system, then upload them to OnBase. Once in the system, all documents are secure, allowing only certain users to edit, as defined by a group’s processes. Based on a workflow designed and validated by each user team, OnBase can then distribute the documents to necessary personnel and track actions, like whether those personnel have read and acknowledged the document.

The system also safeguards against accidental use of old documents. If a new version of an existing document is uploaded, old versions are automatically archived and blocked from distribution. OnBase also complies with FDA 21 CFR Part 11 regulations, which define requirements and control of electronic documents.

The need for this type of an electronic solution was a long time coming, says Sharyl Zaccaglino, director of research quality and compliance at the Medical Center.

“Several years ago, I interviewed groups around the university that operate in a regulated environment to understand their pain points. One thing that nearly every group said they desired was a way to electronically manage their SOPs,” said Zaccaglino. “We’re very excited to have OnBase in place, and expect it will help researchers save time and money, as well as reduce audit findings.”

If you are interested in implementing OnBase for your lab or team, contact Sharyl Zaccaglino or Academic IT. To learn more about the platform, visit OnBase.

While studying a large group of individuals with chronic lymphocytic leukemia (CLL), a Wilmot Cancer Institute scientific team made an important discovery — these patients had a  600 percent higher risk of melanoma, the most dangerous form of skin cancer.

Although a higher risk of melanoma had been known, a full analysis of detection rates and treatments among CLL patients has never been reported before, says Clive Zent, an international expert in CLL who led the study. It was published by the journal Leukemia Research.

As a result of this new data, Zent recommends that all clinical teams that care for CLL patients should actively monitor for melanoma as a part of routine care. The goal is to catch the skin cancer early and manage it with the newest targeted therapies.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” said Zent, a professor of hematology/oncology and medicine at the  Medical Center and Wilmot. “Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors, and also the likelihood that they will become invasive or spread to distant sites.”

Study results showed that 22 melanomas were diagnosed among 470 people in the cohort, a rate that’s more than 600 percent higher than what would be expected in a similar group of age- and gender-matched people from the general population.

Read more here.

(The Shared Resource Laboratories (SRL) have invested $3 million in the last year in new state-of-the-art instrumentation.  These advanced technologies will enhance the University’s research capabilities in microscopy, mass spectrometry, genomics, and flow cytometry.  This is the fourth in a series on the new instrumentation.)

Flow cytometry is a powerful technique to analyze and isolate cells of interest in a phenotypically defined manner.

This allows researchers to understand complex relationships at the cellular level and feed downstream applications, such as genomics analysis, with highly purified populations of cells.

The Flow Cytometry Shared Resource (FCR) core currently features 8 dedicated staff, 6 traditional analyzers, with capacity for detection of 4 to 18 fluorescent parameters simultaneously, 2 high-end cell sorters as well as the ImageStream imaging flow cytometer and the CyTOF mass cytometer.

Last fall, through a generous donation from the Wilmot Cancer Institute, the FCR was able to acquire the Bio-Rad S3e cell sorter.  This 4-color, 2-laser system has a host of features that allow for automated startup and walkaway sorting of up to two populations of interest.

These features will allow for researchers to be trained to run this system at their convenience.

(The Shared Resource Laboratories, which are directed by Tim Bushnell, provide leading edge services and instrumentation to researchers across the University.  The new acquisitions were made possible through a combination of internal investment, NIH grant supplements, and NIH SIG grants.)

Ellen Matson, assistant professor of chemistry, who is the recipient of the 2018 Edith Flanigen Award, presented annually by a German collaborative research center to “an exceptional female scientist at an early stage of her career (postdoctoral fellow, junior researcher) for outstanding results on metal oxide water systems.” Collaborative Research Centre 1109 brings together scientists from four universities and three non-university institutions in Germany, including the Fritz Haber Institute and Humboldt University, to do research on the complex atomic scale processes underlying oxide formation, structural evolution and dissolution. Matson, who joined the University in 2015, investigates the synthesis and characterization of heterometallic metal-oxide clusters, combining her training in redox-active inorganic complexes with new directions in self-assembly synthesis in metal oxide clusters. Her interests primarily lie in the development of new molecules for applications in energy storage and the production of chemical fuels. She has also received a National Science Foundation CAREER award (2017) and, earlier this year, was recognized in the Chemical Communications Early Investigator Issue and with a Course Hero Woodrow Wilson Fellowship for Excellence in Teaching.

It is essential for science to ensure that the individuals included in clinical research are representative of all those affected by the disease or condition in question.

The National Institutes of Health’s Inclusion Across the Lifespan Policy was issued December 19, 2017, and expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also clarifies potential justifications for age-based exclusion criteria and requires participant age at enrollment to be provided in progress reports.

The policy applies to all grant applications submitted on or after January 25, 2019.

Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy. The NIH has many resources on their website to help investigators implement this new policy.

The University’s Office of Undergraduate Research coordinates the Undergraduate Placement Program (UR-UPP), which uses faculty and staff submissions to streamline the process of connecting prospective mentors with undergraduates interested in research.

The program is currently looking for prospective mentors (PIs, faculty, post-docs, research staff, and graduate students) interested in working with undergraduates now or in the future.

If you have questions, please contact Teresa Long, at 276-4522. Click here for additional information.

Paul A. Offit, a pediatrician specializing in infectious diseases and an expert on vaccines, immunology, and virology, will present a lecture as the next Gilbert B. Forbes Scholar during Pediatrics Research Celebration Day on October 11. Offit, the co-inventor of the rotavirus vaccine, will speak from noon to 1 p.m. in the Class of ’62 Auditorium.

There will also be a scientific poster session from 11 a.m.  to noon and 1 to 2 p.m. in the Flaum Atrium.

Chelsea Lyons Katz, health services research & policy, “Understanding Differences in Cardiovascular Care for Acute Myocardial Infarction Patients with a Comorbid Mental Illness.” 1 p.m., August 17, 2018. Helen Wood Hall 1W-509. Advisor: Peter Veazie.

Michael Melnick, brain and cognitive sciences, “Neural Efficiency and Processing: Understanding Visual Perceptual Processing using Transcranial Electrical Stimulation and fMRI in Cortically Blind Humans.” 10 a.m., August 20, 2018. 269 Meliiora Hall. Advisors: Duje Tadin and Krystel Huxlin.

Adam Purtee, computer science, “Toward Better Reasoning from Natural Language.” 3 p.m., August 22, 2018. Goergen 109. Advisors: Lenhart Schubert and Daniel Gildea.

Yan Zou, mathematics, “RO(D_{2p})-graded Slice Spectral Sequence of HZ.” 2 p.m., August 23, 2018. Hylan 1106A. Advisor: Douglas Ravenel.

Peter Bils, political science, “Essays on Policymaking and Expertise.” 10 a.m., August 23, 2018. Harkness 329. Advisor: John Duggan.

Aug. 27: Deadline to apply to the Pilot Studies Program of the Clinical and Translational Science Institute (CTSI) for seed funding for highly innovative research that spans the translational spectrum in three categories: faculty, trainee, and UNYTE Translational Research Network. View the Request for Applications (RFA).

Aug. 27: Deadline to apply to the CTSI Incubator Program for “super-pilot projects,” two years in duration, that are intended to accelerate innovative scientific discovery in the life sciences and public health, leading to new independently funded research programs. Each award is funded at a maximum level of $125,000 per year for each of two years. View the Request for Applications (RFA).

Sept. 14:  Workshop on basic components of writing successful proposals for humanities grants and fellowships, plus writing session so that you can kick-start your proposals. 10 to 11:30 a.m., Rush Rhees Library Instruction Room B.  The session will end with an opportunity for immediate feedback on your proposal drafts and ideas. Geared toward graduate students in the humanities, but open to all interested grad students. Bring a laptop, and RSVP here.

Sept. 17: Deadline to apply for the Falling Walls competition. Winner of the Rochester competition, to be held October 2 in the Feldman Ballroom, will receive $500 and a trip to the Falling Walls Lab Finale in Berlin, November 7 to 9. Presenters will each have three minutes and three slides to summarize their groundbreaking ideas. Click here to register. Contact Adele Coelho, faculty outreach coordinator, at adele.coelho@rochester.edu for additional information.

Sept. 24: Deadline to apply for Novel Biostatistical and Epidemiologic Methods awards to overcome specific analytic limitations and significantly enhance the validity and accuracy, scope, or speed of clinical or translational research. A maximum of $35,000 will be awarded for a one-year period. View the request for applications (RFA).

Sept. 27: Workshop on Developmental Programming of Disease, focusing on current understanding of mechanisms that underlie early life programming. 8:30 a.m. to 5:30 p.m. Class of ’62 Auditorium. Offered by the Department of Environmental Medicine and the University’s Environmental Health Science Center. Free and open to all. Registration is requested for ordering refreshments. Read more here.

Sept. 30: Deadline for Medical Center tenure track faculty and their chairpersons to apply for up to $75,000 in bridge funding during a hiatus in research support. All questions and applications should be directed to Anne Reed. For more information, click here.

Oct. 11: Pediatric Research Celebration Day. Lecture by Paul A. Offit, a pediatrician specializing in infectious diseases; an expert on vaccines, immunology, and virology; and co-inventor of the rotavirus vaccine, from noon to 1 p.m. in the Class of ’62 Auditorium. Scientific poster session 11 a.m.  to noon and 1 to 2 p.m. in the Flaum Atrium.