Office of Research Services Launches the Research 411 Portal

Do you need help navigating research systems at ISMMS?

The Research 411 Portal is the place to get answers to your questions about how to navigate the conduct of research throughout the MSHS. It is a help desk ticketing system where you can ask general questions through Research 411 or get help with the services that the Office of Research Services (ORS) offers. See the below menu of services offered. The ORS team is dedicated to helping researchers navigate the expanding research enterprise of the MSHS.

How to use the Research 411 Portal:

Go to the Office of Research Services (ORS) website and click on ORS Research 411 Portal. You will see the below menu of current Research 411 Portal tickets, click on a ticket, complete the form and hit send!

TIP: If you’re not sure which ticket to use, or if there isn’t a ticket for your specific questions, use the general Research 411 form at the top of the list of choices.

New services are continually added as the research enterprise continues to evolve. Announcements about new services will be made via the ISMMS Research Listserv. Please make sure that you are subscribed by entering your email address under “Research Listserv” on the  Research Web Portal’s Getting Started page (within the MSHS firewall) to ensure you stay informed.

 

ClinicalTrials.gov Spotlight Series: Understanding ClinicalTrials.gov Registration and Reporting Dates

As of January 17th, 2018 the new NIH penalties for non-compliance with Clinicaltrials.gov registration and reporting went into effect. The potential penalties are financial, at over $11,000 per day of non-compliance, and may impact continued funding of both existing and future NIH awards.

What you need to know to achieve compliance:

Understanding the Date & Deadline requirements

When registering a study in ClinicalTrials.gov, specific dates must be provided – if the PI is uncertain about an exact date, the best anticipated date must be provided until an actual date is available.  Dates cannot be left blank.

What are the dates that must be provided?
*A primary outcome measure is the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one. For more information see, ClinicalTrials.gov Outcome Measures & Statistical Analyses Module.
Source: https://clinicaltrials.gov/ct2/about-studies/glossary

NOTE:

  • In some cases the primary completion date and study completion dates are the same.
  • In other cases, the primary outcome measures may be collected much earlier than the secondary. And yes, results for the primary outcome measure must be posted within 1 year of this date.

Other deadlines to remember

  • Records must be updated every 12 months.
  • Records must be updated within 30 days of Recruitment Status changes or amendments that affect information in ClinicalTrials.gov record, especially recruitment status, location and contact information.
  • Records must be updated within 30 days after the completion date (last data collection).
  • After initial submission of registration data, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 15 days (yes, this includes weekends).
  • After initial submission of Results, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 30 days.

All unmet dates and deadlines trigger errors in ClinicalTrials.gov  and a status of “non-compliance” in ClinicalTrials.gov.

Questions? Please open a ticket via the ORS Research 411 Portal’s ClinicalTrials.gov Assistance form.

 

The Research Listserv

  • Do you conduct research, or would like you like to be involved in research within the Mount Sinai Health System (MSHS)?
  • Are you seeking funding for your next big idea?
  • Would you like to keep up-to-date about research administration policies and procedures at Icahn School at Mount Sinai?

The Research Listserv can help.

The Research Listserv is one single email list encompassing the entire research community. If you do research at MSHS, you may already be a member of the Research Listserv. To check if you are a member or to change your subscription preferences, click here and enter your email address under Research Listserv at any time within the MSHS firewall (on-site at a MSHS location or via VPN). If you are not a member, your email selections will be blank. To join, or edit your existing preferences, choose your topics and click  at the bottom of the page. You will receive an email confirming your subscription or any changes you make.

You will be able to choose from the following:

Not convinced? Maybe this will help –

  • You can modify your subscriptions at any time by entering your email address under Research Listserv on the Research Portal Getting Started page, when you are within the MSHS firewall. You will always receive a confirmation email when you change your subscription preferences.
  • You can unsubscribe from everything, and still be assured that you will receive messages intended for the entire research community (Dean’s Office or the most important messages from the GCO, IRB/PPHS, IACUC, etc.).
  • You will receive each mailing ONLY ONCE, unless you are subscribed with two functional email addresses. If that should happen, email research.services@mssm.edu, and we will take care of it immediately.

If you are part of the research community of the Mount Sinai Health System, you should be a part of the Research Listserv. Join today!

 

Time for an Annual Mailing List Subscription Check-up with the Research Listserv

On March 1, 2017, the Office of Research Services (ORS) and the Research Information Technology Department launched the Research Listserv for research related mailings throughout the Mount Sinai Health System.

For the last year, it has served as a primary source of research related information for the Mount Sinai Health System (MSHS), sending out nearly 450 emails to our more than 4000 subscribers from throughout the system, many of whom may be unaware of their power to customize their subscription preferences according to their interests and roles in research.

Two of the Research Listserv’s founding goals were to provide choice to users and to limit duplicate blast emails. Therefore, it sends mailings out according to topic and subject, selections that can be made by a user at any time within the MSHS firewall by entering their email address under Research Listserv on the Getting Started page of the Research Web Portal. If a subscriber picks every list below, they can expect to get a broad range of announcements without duplication of individual mailings. Below are the lists from which subscribers can choose:

Human Subjects Research

  • Guidance & Education
  • Events
  • News

Animal Research

  • Guidance & Education
  • Events
  • News

COREs

  • Guidance & Education
  • Events

Grant Submission & Management

  • Awards & Funding Opportunities
  • Events
  • Policies, Procedures & Education
  • NIH and other Funding Agency News

Research Resources

  • Guidance & Education
  • Events
  • News
  • Resources, Supplies & Equipment

IDEATE

  • News & Status

It is vital that new research hires and any research personnel who are not getting these emails visit the Getting Started page on the Research Portal where they can find the Research Listserv box and enter their email address to join. Important research related announcements are made by the Dean’s Office as needed, and so please pass the word along. Once new members click on “Save Changes,” they are subscribed and will receive a confirmation email summarizing their selections.

Please feel free to open a ticket with the ORS Research 411 Portal’s Communications Support form for assistance with subscribing,  if you have questions about the Research Listserv, or if you have a message that you need to send to the research community.

New Research Help Desk is Coming – ORS Research 411 Portal

The Office of Research Services (ORS) serves as a central resource that provides navigation and consultations to Mount Sinai Health System researchers about research processes, resources and systems. Over the last few months, ORS has developed a new streamlined help desk ticketing system called the ORS Research 411 Portal to provide a single point of contact for research teams to ask any research operations related questions and access assistance with the consultative services that the ORS offers. These include, ClinicalTrials.gov registrations & reporting, IND & IDE application support, protocol development, training & education, recruitment, and multi-site study development & coordination. The Research 411 Portal is in the final stages of testing and it will be fully launched by June 2018. In the interim, please visit the ORS Research 411 Portal for your research needs. We welcome your feedback at research.services@mssm.edu.

Centralized FedEx Service Established

The Office of Research Services is pleased to announce that its piloted process for shipping biological substances for clinical trials via FedEx at Icahn School of Medicine at Mount Sinai has facilitated nearly 2000 shipments since its pilot in April 2016. Mailroom Assistant Manager Sybil Allen reports, “the program has been a great success, and I work very closely with the Manager at FedEx, who makes sure that the packages are picked up on time.” Due to consistently positive feedback and increasing traffic, growing to an average of 40 packages per week in recent weeks, this service is now available on an ongoing basis.

Clinical trial shipments with a FedEx pre-paid label can be dropped off at the mailroom by 4:00pm for same-day shipping. Any FedEx shipments after 4:00pm will continue to be the responsibility of the research team. The mailroom is located on the SB Level of 5 East 98th Street, and Assistant Manager Sybil Allen can be reached at (212) 241-6161 (x46161).

For all shipments, the study team must 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/). 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 regarding this process, please open a ticket with your question to the Office of Research Services via Research 411.

 

ClinicalTrials.gov Policy Announced by the Office of Research Services

The ISMMS Office of Research Services (ORS) ensures institutional compliance with the U.S. Department of Health and Human Services (HHS) final rule for ClinicalTrials.gov registration that went into effect this year. To support this effort, the new ISMMS policy on ClinicalTrials.gov has been posted on the intranet policies page under “Research” and on the ORS website toolkit page. The policy clarifies compliance with the federal requirements for registration and reporting for all Mount Sinai Health System and medical school faculty, students, and staff conducting or involved in clinical trials research.

If you would like to request support with a ClinicalTrials.gov registration, please visit ORS Help Center’s ClinicalTrials.gov Assistance ticketing system, create a login (if necessary, a one-time process), and fill in the form to submit your request.

New Email Management System: Research Listserv!

On Wednesday, March 1st, the Office of Research Services and the Research Information Technology Department announced the launch of the new Research Listserv for research related mailings throughout the Mount Sinai Health System.

The Research Listserv is a single source of dissemination of research related information to the Mount Sinai Health System. It will replace the current communication process of distribution through 3 separate, and sometimes redundant, lists:

  • CRC List (crclist@mssm.edu)
  • Research Faculty (researchfaculty@mssm.edu)
  • Research Resources (researchresources@mssm.edu)

These 3 email addresses have now been retired, and all research-related mass emails are sent from “research.listserv@mssm.edu.”

Q: How do you subscribe to ensure that you continue to receive research mailings?
A:
You can go to the “Getting Started” page on the Research Portal and enter your email address into the Research Listserv box, where you can edit your account at any time (within the MSHS firewall).
A: Please note:
You might have already been subscribed because:

  • You were already subscribed to any or all of these 3 lists: CRC List, Research Faculty and Research Resources and more recently to the Ideate listserv, and you were automatically migrated to the new Research Listserv.
  • If you were not subscribed to one of the above 3 listservs, you may have been added to the new Research Listserv by your Department Administrator because you were identified as research personnel.

Q: What if I need to add new subscribers?
A:
If you want to let someone know how to subscribe themselves, direct them to the “Getting Started” page on the Research Portal. Find the Research Listserv box and enter their email address. They will receive a confirmation email.

Q: What is different?
A:
The Research Listserv provides:

  1. Management of email preferences. You can now choose the research topics that are relevant to your research focus and opt-out of topics that are not relevant to you.
  2. Elimination of duplicate emails – NOTE: For those of you who have @chpnet.org, @mssm.edu & @mountsinai.org addresses, if you enter more than one email address, you will continue to receive duplicate emails. If you notice that you are receiving duplicate identical emails, it is most likely because you have two different email addresses in the system. Please email research.listserv@mssm.edu, and we will work with you to manage your preferences.
  3. Mandatory emails:  regardless of your email preferences, vital research related emails from MSHS leadership will reach the entire subscribed population.

What you should do:
Review your current email preferences and finalize your selections by entering your email address in the box under “Research Listserv” on the “Getting Started” page of the Research Portal. You can return to this portal at any time to edit your subscriptions as long as you are within the institutional firewall.

Please note that this new system is no longer categorized by group i.e., CRCs, Research Faculty, but rather by topic. For example, if you are a clinical research coordinator (CRC), you will need to select topics in the “Grants Submission & Management” category on the subscription page to receive messages from the Grants and Contracts Office.

Please feel free to contact the Research Listserv team at research.listserv@mssm.edu, if you have any questions or other feedback.

 

4D CTSA Technology Development Awards Announced

With support from ConduITS, the Institutes for Translational Sciences, the 4D (Discover, Design, Develop, Deliver) Technology Development Projects promote technology-based solutions for unmet needs across the healthcare system in therapeutics, diagnostics, devices, and digital health. This program takes a mentored approach to facilitate the teams executing their plans.

Please join us in congratulating the following team leaders awarded for this cycle (Fall 2016-March 2017):

  • Jamilia Sly, PhD Instructor, Department. of Oncological Sciences

Internet-Based Patient Activation Intervention to Improve Referrals for Cancer Screening (PAIRS)

  • Ya-El Mandel-Portnoy, 5th year PhD Candidate, Emergency Medicine K12 Scholar

Developing cutting-edge technology to improve the treatment and quality of life of Atrial Fibrillation patient

  • Sander Houten, PhD, Associate Professor Genetics and Genomic Sciences

Novel Treatments for Glutaric Aciduria

  • Ilse Daehn, PhD, Assistant Professor, Department of Medicine, Division of Nephrology

Predictive Biomarkers for Diabetic Nephropathy (DN)

  • Evren Azeloglu, PhD, Assistant Professor, Department of Pharmacological Sciences

Next Generation Bandages for Improved Wound Healing

If you would like more information about this program, please contact the Louise Lammers at louise.lammers@mssm.edu.

 

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.