Featured Research Program
VA-IMPACT – CSP 2002
Local Site Investigators: Dr. Laure Sayyed Kassem
Study Coordinator: Larraine Gordesky
Study Objectives:
CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in patients with pre-diabetes and established atherosclerotic cardiovascular disease.
Study Inclusion:
To qualify for CSP #2002, participants must have:
a) pre-diabetes defined by hemoglobin A1c (HbA1c) of 5.7 to 6.4; fasting plasma or serum glucose levels; or oral glucose tolerance testing criteria in the absence of diabetic treatment
b) established coronary, cerebrovascular, or peripheral arterial disease
c) an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2.
The primary efficacy measure is the time to first occurrence of death from any cause, myocardial infarction, stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or symptom-driven coronary revascularization.
Study Details:
This study plans to enroll about 7410 veterans nationwide. Individual participation will last 3 -6 years depending on when enrolled. The recruitment period will last approx. 3yrs. Study visits consist of consent/screening, randomization (within 31 day of screening). quarterly follow-ups done by phone and yearly lab visits.
For more information, please contact the Impact Study team at the Clinical Research Center in room 1C 370 or at 216-231-3241.
You can watch the study video by clicking the link below:
https://players.brightcove.net/2851863979001/default_default/index.html?videoId=6318932875112
Research Forums
Research forums will be held monthly. Our spring schedule is listed below. Presentations will be broadcast using MS Teams.
Tuesday, March 26 @ 1:00PM
Getting to know the Cleveland VA Research and Education Foundation (CVAREF), presented by, Jeffrey Moore, Ph.D., Executive Director and Marcie Denallo, Grants Manager
Microsoft Teams meeting; Join on your computer, mobile app or room device
Meeting ID: 274 189 817 615 Passcode: qFJwSr
Click here to join the meeting
Tuesday, April 23 @ 1:00PM
Reportable Events and ICFs , presented by, Joy Volpi, IRB Administrator
Tuesday, May 21 @ 1:00PM
Non-Veterans in VA Research, presented by, Christina Bennett, Health System Specialist - Research & Development Committee Administrator
State of the APTC 2024
Please join the APT Center Wednesday, March 27th 3pm - 4pm for the annual State of the APT Center Presentation
This will be a Hybrid Event. We encourage everyone to join us in-person at the Cleveland VA Admin Building (EUL 1st Floor Lobby). See attached map for directions if needed.
For those who cannot join in-person, please tune in using the Teams link below.
A few notes:
- Light refreshments will be provided
- We will have a game with chances to win a few prizes for those that appear in-person!
- For virtual attendees, please mute and turn off your video.
- There will be an opportunity to ask questions at the end; please enter questions in the chat.
Microsoft Teams
Join the meeting now
Meeting ID: 266 712 907 502
Passcode: bQx25c
Dial-in by phone
+1 205-235-3524,,514675435# United States, Birmingham
Find a local number
Phone conference ID: 514 675 435#
For organizers: Meeting options | Reset dial-in PIN
Electronic Process of Conflict Interest Disclosures
VANEOHS is pleased to announce the adoption of the IRBNet suite of tools for submission of electronic Conflict of Interest (COI) disclosures.
VANEOHS is now accepting electronic COI submissions via IRBNet. Beginning on March 18, 2024, all disclosures (including revisions and renewals) must be submitted electronically via IRBNet, and all decisions will be issued electronically via IRBNet.
- Instructions and guidance for the new MyCOI process will be uploaded to the IRBNet Forms and Templates library (VANEOHS Research Administration, Cleveland, OH – Documents for Researchers) and the VANEOHS Research website for reference.
- The old PDF COI forms will temporarily remain on the VANEOHS Research website to accommodate submissions that are in progress. It is recommended that the PI work with their team when planning to submit COIs during this transition period to ensure all investigators are informed as to what form (new or old) should be used as all investigators on a project must submit their COIs via the same method.
- If there are any questions or if assistance is needed while compiling a submission during this transition period, please contact the VANEOHS Research Administrative Staff responsible for your project, or the VANEOHS VAIRRS general mailbox at VHACLEVAIRRS@va.gov .
March 18, 2024
- Packages submitted on or after this date must use the new MyCOI process.
- Any package submitted on or after this date with an old/discontinued COI form will be returned for correction.
Office Hours (Research Compliance & Education)
Research Compliance Office & Research Service (Education) have an open forum via teams the 2nd & 4th Wednesday of each month from 12:30pm-1:00pm. NOTE the new time.
During the office hours you can ask any questions that you may have about Research Compliance/Research Education.
If you have topics that you would like us to discuss in future office hours, please send an email to Jennifer Zindle jennifer.zindle@va.gov
Please use the link below to join us on Wednesday, March 13, 2024
Join on your computer, mobile app or room device
Click here to join the meeting
Meeting ID: 236 321 831 958 Passcode: HAvGVK
Study Initiation Visits
What is a Study Initiation Visit?
The study initiation visit encompasses a review of regulatory requirements as they apply to your specific study, good clinical practice guidelines, the informed consent and HIPAA documents as well as a review of how to maintain study records (regulatory binder and subject files).
The Research Compliance Office is required to perform a triennial regulatory audit of studies (human subjects' research, animal protocols, and basic science studies) and informed consent and HIPAA audits if applicable. The intent of a study initiation visit is to help the researcher avoid the most common audit findings before they occur.
Did you know that you can schedule a Study Initiation Visit with the Research Service?
The study initiation visit is available to all research staff. If you are new to research or need a refresher, you can schedule a study initiation visit today.
For scheduling or questions contact Candice Toney at Candice.Toney@va.gov or 216-791-3800 x66785.
Upcoming VA Research Funding Deadlines
The next BLR&D and CSR&D Career Development Letter of Intent (LOI) submission deadline is May 1st, 2024.
The next round of RR&D and HSR&D VA Grant Applications will be submitted June 8th.
Please contact Christine.Hendricks@va.gov if you are planning to submit or have any questions.
Office of Research & Development
Upcoming Webinars: Office of Research Protections, Policy, and Education Webinars (va.gov)
Archived webinars can be found at: ORPP&E Webinar Archive (va.gov)
Recent webinars:
(1/24/2024) VAMC Reimbursements
(12/20/2023) HRPP Bimonthly Updates in VA Research: December 2023
(12/19/2023) Implementation of VHA Notice 2023-09, Outside Compensation for Performance of VA Research
(12/14/2023) Finance Monthly Training: Explaining VA Funding Requirements to Principal Investigators
Stay Connected
VA Northeast Ohio Healthcare System
Cleveland Research Website
Office of Research & Development
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