xTRACT Support for September 25th NIH Institutional Training Grant Deadline

If you are planning to submit an institutional training grant for the September 25th NIH deadline, you are invited to contact Allison Gottlieb at allison.gottlieb@mssm.edu, for a one-on-one training on using “xTRACT,” a software module in eRA Commons, still in pilot phase, that generates the required tables.

In addition, below are other NIH institutional training grant table resources.

Please stay tuned for emails and additional information about updates relating to the January 2017 deadline.

 

Are You Recruiting Healthy Subjects for Clinical Research?

The Office of Research Services periodically receives inquiries from members of the general public seeking opportunities to participate in clinical research projects. In order to serve our research community and the community at large, we are establishing an informal list of studies that are currently seeking participants. If you would like to add your study to this list, please submit a Research Subject Recruitment Request with a copy of the current IRB-approved consent and preferred contact information.

 

Epic for Research Participant Recruitment

The Office of Research Services (ORS) and the Epic Clinical Transformation Group are pleased to invite the Mount Sinai clinical research community to unlock the potential of the Epic Electronic Health Record (EHR) system for clinical research subject recruitment. Originally piloted by the Clinical Trials Office of Tisch Cancer Institute (TCI), Epic Clinical Trial Alerts (CTAs) can help make a meaningful match between clinical researchers and clinicians who have recently seen potentially eligible subjects for their studies.

Epic CTAs create alerts, visible to care providers at the point of care, in the Epic EHR for patients matching screening criteria for a clinical trial. The provider can then discuss with the patient and choose “yes, interested” in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent.

Myeloproliferative disorders (MPD) are a group of slow-growing blood cancers in which large quantities of abnormal red blood cells, white blood cells, or platelets grow and spread in the bone marrow. The MPD Program at TCI is one of few comprehensive, multidisciplinary programs in the Northeast offering extraordinary expertise and personalized treatments, backed by extensive research and clinical trials. The Cancer Clinical Trial Office’s MPD Research Program was able to identify 65 additional eligible patients, of which 13 were successfully enrolled in a clinical trial. This EHR CTA pilot accounted for 23% of the new subjects enrolled into MPD therapeutic clinical trials.

For more information, visit http://icahn.mssm.edu/research/resources/office-of-clinical-research/research-subject-recruitment-tools/epic-for-research-participant-recruitment, or Mount Sinai Health System researchers can also contact Joseph Kannry, MD, Lead Technical Informaticist, for further details or with questions about the functionality being offered via the Epic EMR.

 

Centralized FedEx Shipping of Biological Substances for Clinical Trials

On April 14, 2016, the Office of Research Services (ORS) announced a new pilot process for centralized FedEx shipping of biological substances for clinical trials at Icahn School of Medicine at Mount Sinai.

Effective Monday, April 18, 2016, clinical trial shipments with a FedEx pre-paid label may be dropped-off as follows:

  • Location of drop-off:  Mailroom on the SB Level of 5 East 98th Street
  • Drop-off Time:          On or before 4pm, Monday thru Friday
  • Mailroom Contact:     Assistant Manager Sybil Allen (212) 241-6161 (x46161)

Packages must be dropped off with a FedEx pre-paid label by 4:00pm to ensure same-day shipping. Any FedEx shipments after 4:00pm or on the weekends will continue to be the responsibility of the research team.  For all shipments, please ensure the shipper is IATA Certified and that the label and packaging are in compliance with current regulations for shipping biological substances (http://www.un3373.com/info/regulations/).

This initiative, which was developed in response to feedback from our research community, seeks to establish a more streamlined process for using FedEx for clinical trial shipments.  The pilot process will be reviewed after three months to ensure it has made a positive impact for our investigators and research staff.

If you have any questions about shipping biological substances, please email Mark Matthews, Director of Environmental Health and Safety, at mark.matthews@mssm.edu.

If you have any questions, concerns or feedback regarding this pilot process, please reach out to Sonia Kleiner-Arje, Director, Office of Research Services (ORS), at sonia.kleiner-arje@mssm.edu or 212-824-7640.

 

Rosalind Wright Assumes Leadership Roles in Translational Research

Effective November 1, Rosalind Wright, MD, MPH assumed the dual leadership roles of Dean of Translational Biomedical Research and Director of the Clinical and Translational Science Award (CTSA) at the Icahn School of Medicine at Mount Sinai.

As Dean for Translational Biomedical Research, Dr. Wright provides leadership for clinical and population-based research across the Mount Sinai Health System, applying her expertise and vast experience to supporting and growing our research endeavors. This role dovetails with her directorship of the CTSA, recently re-funded by the NIH to foster high-quality translational research, research education, and the development of innovative resources. Through Mount Sinai’s Conduits program, the CTSA spurs collaborations among clinicians, patients, and scientists, and builds partnerships across a national network of CTSA programs.

“As technological advances and evolving insights into disease causation and individual variation increase the complexity of research and its translation into clinical practice, we are challenged with moving forward integrated team science that informs what genes, environment and life stage mean to defining normal variations and altered health trajectories throughout the life course and across generations,” said Dr. Wright of her new roles. “This is an exciting time for science and medicine with Mount Sinai continuing to lead the way.”

Dr. Wright is a Professor in the Departments of Pediatrics and Preventive Medicine. As a pulmonologist and life course epidemiologist, she has special expertise in prenatal and early childhood factors contributing to the programming of chronic diseases. She has built a large National Institutes of Health (NIH)-funded research program focused on understanding the role of both chemical and non-chemical social stressors in perinatal programming of conditions such as asthma, obesity, cardiometabolic disorders, and neurodevelopment, particularly as they relate to health disparities in socioeconomically challenged urban populations. Dr. Wright’s pioneering research on the role of social factors and toxic stress on disease programming starting in pregnancy was recently recognized through her election as a fellow to the National Academy of Behavioral Medicine Research.

As we welcome Dr. Wright, we want to thank Hugh Sampson, MD, who is scaling back his administrative positions at Mount Sinai to assume a role as Chief Scientific Officer for DVB Technologies, a company that is developing treatments for pediatric food allergies. We wish him well in his new external position and, at the same time, are pleased that he will continue to be a visible, vibrant presence in the Icahn School of Medicine research community.

 

Agreement Navigator Launched

In July, the Office of Research Services launched a new tool called the “Agreement Navigator.” If you ever have had an agreement and you weren’t sure where it was supposed to go for processing and signature, (was it GCO or maybe MSIP or was it the FACTS office?), this new resource will help you. Confidentiality Agreements, Data Use Agreements, Subaward Agreements, and Grant Agreements are some of the categories you will find. Click here to open the Navigator. The Grants and Contracts Office posted a link in the Getting Started section of the GCO Application Info webpage and the Policies and Procedures section as well.

 

Welcome to Research Digest

The Office of Research Services (ORS) has teamed up with the Program for the Protection of Human Subjects (PPHS) Office, the Grants and Contracts Office (GCO), other research administration offices, and the Office of the Dean, to deliver important news and information about research to your inbox every quarter.  View prior issues of Research Digest here.