Our previously published newsletters are available on our website. You can find them here.
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This month we are shining a spotlight on MINT: The Myocardial Ischemia and Transfusion Trial. This trial, which is funded by the National Heart, Lung and Blood Institute at the NIH, is currently being conducted at 144 sites across the US, Canada, France, Brazil, Australia, and New Zealand. This study seeks to answer the question of whether clinical outcomes in anemic patients with acute myocardial infarction are improved with a liberal transfusion strategy (i.e. infusing red blood cells at a hemoglobin level ≥10 g/dL versus a more restrictive threshold of <8% g/dL.
Our own Dr. Jeff Carson, Provost-New Brunswick for RBHS and Chair of General Internal Medicine at Rutgers Robert Wood Johnson Medical is the PI for the study internationally. The trial has enrolled nearly all of the planned 3500 patients, (including 103 at Rutgers), and is scheduled to be completed this year. The trial results are eagerly awaited, as they will certainly impact transfusion medicine guidelines worldwide. Congratulations, Dr. Carson and the RWJMS MINT Team!
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Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow RBHS study teams!
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Rutgers Earns Prestigious Accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) |
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You can find the full press release on this fantastic news for Rutgers here.
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Regulatory Tip of the Month |
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New Tool Available:
Quality Assurance (QA) vs.
Human Subjects Research (HSR) Flowchart
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Does your quality improvement project require IRB Review?
A new flowchart was recently developed under the direction of Dr. Ethan Halm, RBHS Vice Chancellor for Population Health, by a multidisciplinary group including HRPP and NJ ACTS staff.
This self-service tool is designed to help researchers determine whether their proposed quality improvement project requires IRB review or not. This tool can be found on the IRB website, under Quality Activities in the section on HRPP Guidance Topics.
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What do I do when a PI departs Rutgers or takes a leave of absence midway through a study? |
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Here is a step-by-step guide:
1. Inform the sponsor. Check with the CTO first, though, because the possibility of the PI leaving is ordinarily addressed in the clinical trial agreement (CTA), and you’ll want to be sure your actions are compliant with the CTA. The CTA may obligate you to inform the sponsor within a certain time period. It may also be helpful to have a replacement PI in mind, and have that investigator’s CV available to forward to the sponsor.
2. Update OnCore. Once the sponsor approves the new PI, an OnCore “Change Review” submission is required. To indicate the reason for the “Change Review,” you’ll upload a draft CTA amendment (or equivalent) that the sponsor will have provided. You’ll also need to update the OnCore staff list by giving the outgoing PI an end date, and adding the new PI.
3. Submit a modification request through eIRB and also to the IRB of record, if different. Seek guidance from the IRB and/or sponsor as to how participants should be notified of the change in PI (for example, through re-consent vs. a letter to the participant.)
4. Complete the required regulatory documents (i.e. updated 1572, delegation of authority log, financial disclosures, investigator signature pages, etc.)
5. Request guidance from the sponsor! They are often a great resource for ensuring regulatory compliance and proper documentation of the change in PI oversight.
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We have a new Investigator-Initiated Trial (IIT) that isn’t funded yet, but, we want to get started with SRB and IRB. What should we do? |
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First, submit the study for review by the RBHS Scientific Review Board through OnCore ePRMS (or through the REDCap link if the study does not entail billable clinical procedures) and note Rutgers as the primary study sponsor. Once you have SRB approval, you can submit to the IRB for approval. Once the funding comes through, you’ll need to submit an OnCore Change Review to add the funding source sponsor. (Note that, if the funding comes from Industry, you’ll also need to append the draft contract to the Change Review in order to request review of the contract.)
Second, submit a modification request to the IRB to add the new sponsor and/or funding source. You’ll likely also need to update the protocol and the consent forms to reflect the new sponsor and/or funding source. Last, be sure to complete the RAPSS Funding Proposal as required.
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Befuddled by a question or two on a sponsor’s feasibility questionnaire for a new study? |
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The CTO can help, whether it be by providing estimates of the patient population through Deep6, projected contract and budget turnaround times, logistics for remote monitoring or more. Just shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu
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RBHS Clinical
Research Workgroup
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February 6th, 2023
12:00 pm
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Announcing our first ALL-RBHS clinical research workgroup call! We will be discussing topics including important updates in the Rutgers Human Subject Protection Program, new ClinCard tax functionality and consent language and much more. Hila Berger, Assistant Vice President for Research Regulatory Affairs will be providing updates.
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By Special Request...the ACRP Certification Exam Prep Course is Now Offered Virtually Over 2 Evenings |
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Are you or someone you know considering taking the ACRP certification exam during the Spring Certification Exam Cycle: January 15, 2023 – April 15, 2023?
The New York Metropolitan Chapter of ACRP is offering a virtual certification prep course/study group to assist you in your preparation via Zoom.
All are welcome to register for this preparation and review of covered topics on the ACRP certification exam. Register with Lisette Gonzalez: lgonzalez@phase2phaseconsulting.com or call 917-881-4295
Payment is accepted by credit card, PayPal or check.
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REMINDER! Instructions for scanning signed consent forms into the RWJBH Epic System are available on the CTO website. Note that this is a new, very important requirement from our RWJBH hospital partners in order to comply with JCAHO standards. It will also assure that a copy of the consent form is easily accessible to any member of the patient’s care team who needs to see it.
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Should you encounter any problems following the instructions, please create an EPIC service now ticket (as directed at the end of the document.) If you have any questions about this new directive from RWJBH, please e-mail clinicaltrials@rbhs.rutgers.edu
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Read about the new changes in University Hospital executive leadership here!
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How do I reset a calendar in OnCore when visits are not projecting correctly? |
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Select whether, and by which means, future visit dates should be adjusted if the Visit Date was not the Planned Date. Future visit dates will be adjusted with the same offset from the scheduled date as the current visit. The Reset Calendar functionality is available for the treatment and follow-up portions of the calendar when cyclical schedules are being used. This field is automatically set to No for Missed or N/A visits. |
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How do I put my subjects on a new calendar version? |
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Switching Calendar Versions
The subject’s current calendar version is noted in the subject calendar header. When a newer calendar version is available, the subject calendar will have a Switch Version drop-down box in the bottom left corner of the page. If a new version is selected, the calendar displays a preview of the new version and a [Replace Version] button displays. Click the button to confirm the change.
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Verified Visits and New Calendar Versions
In a new calendar version, visit procedures may be added or removed. If a visit has been verified prior to switching the calendar version, the new subject calendar display reflects this change.
In the scheduling grid, the subject calendar displays an 'X' for the procedure with a subscript 'A' or 'D'. The 'A' subscript indicates that a procedure that was not performed as part of the original visit schedule has been added to the calendar, the 'D' subscript indicates that a procedure that was performed as part of the original visit schedule has been deleted from the calendar.
Subject Console; Calendar; Orphaned Visits:
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If a visit was entirely removed from the schedule in a new version of the calendar and that visit has already been verified, the visit will show on the Orphaned Visits tab on the Subject Calendar. |
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Clinical Research Pet of the Month |
January’s Clinical Research Pet of the month is Shelby! Shelby’s pet parent is Alex Young, Feasibility Navigator for the Clinical Trials Office.
Because Shelby often sleeps with her legs straight up in the air like a dead bug, her humans usually call her “Bug.” Originally from Georgia, Bug is a mystery hound-mix who recently found her home in New Jersey. She is her happiest self when outside where she can run and sniff and socialize, so needless to say, she is not a fan of Zoom meetings. But after a long exercise session, Bug loves to curl up tight and nap in her humans’ laps.
She’s a super smart pup, but she’s still got a lot to learn about living and working from home with humans, so she apologizes in advance for talking (read: barking) out of turn during Alex’s Zoom meetings!
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