Our previously published newsletters are available on our website. You can find them here.
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RWJMS Clinical
Research Workgroup
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Tuesday, June 14th, 2022
1:00 PM
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Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more! |
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Explore the Most Integrated eRegulatory Management System Available
Keep your research moving efficiently and compliantly in a remote environment with Advarra eReg.
Join Advarra for an open demo
Tuesday, June 21, 2022
1:00 PM
Advarra experts will dive into integrated workflows and remote capabilities that save your organization time and effort.
In this open demo, learn how Advarra eReg:
- Connects with your enterprise systems, including new Secure Document Exchange capabilities to significantly accelerate study startup
- Stores all your essential protocol documents, track owners, expiration dates and more, all in a 21 CFR Part 11-compliant system
- Grants specified system access to sponsors and CROs for more efficient remote monitoring
- Efficiently routes documents and manages electronic signature notifications and more!
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Attention RWJMS Clinical Research Coordinators: Please log into EPIC and make sure you see the studies you are responsible for. If a trial is missing, please email clinicaltrials@rbhs.rutgers.edu with the title of the trial.
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If you still need OnCore training: Send an email to jonathan.carter@rutgers.edu
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ePRMS Change Reviews
Do you know what to do in order to get a contract or budget amendment reviewed and executed by the CTO?
A change review should be submitted for the following situations prior to or as close to IRB submission as possible:
- Protocol Amendment
- Budget Amendment
- Contract Amendment
How do I submit a change review?
1. Log in to OnCore.
2. Navigate to ePRMS > Submission Console.
3. Click the Change Review tab on the left.
4. Choose a Review Type of Admin - Non-Oncology.
5. Click the Browse icon and select your protocol.
6. Click Create Submission.
All the protocol details entered in the PC Console populate the ePRMS submission form.
7. Upload your amendment/new documents or information if needed (please include relevant changes in a separate word document).
8. In the Competing Protocols section, select the checkbox for No Competing
Protocol and click Add.
9. At the bottom of the submission, click Send.
Just like an initial review, the submission now appears in the pending tab of the Submission Console.
What happens next?
1. The CTO will begin processing and negotiating the study changes:
- Contract amendment negotiation (Sam Lee)
- Budget amendment negotiation (Joy London or study team)
- Protocol amendments (Justin Blucher and Alex Young)
2. You will receive an OnCore notification via email when the modifications are complete and/or fully executed
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ClinCard Resources
You are probably aware that you can access the ClinCard system to pay your participants through the ClinCard Portal on the CTO website. This site also has information about how to set up a new study, how to get cards, and more.
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But, you may not be aware of ClinCard’s new “In-App Knowledge Center” which is available when you are in the ClinCard portal itself. You can access this feature by clicking the green “books” icon, which you see if the extreme lower right corner of your screen. This is a very helpful resource to help you navigate how to register or look up a participant, how to assign a card to your participant and more. |
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Record Retention
Do you know what to do with all of those study patient files and regulatory binders once your study is over and how long you need to keep them? Turns out, (surprise) it’s complicated. For example, the length of time you need to retain the records depends upon the study sponsor (Government vs. internal vs. other) and whether the study is FDA-regulated or not. And, HIPAA also factors in.
Fortunately, Rutgers has some very helpful resources to help you figure out what to do.
Second: Be sure to check your study contract. According to Sam Lee (CTO Contracts Manager), there is a trend toward sponsors requiring record retention periods in excess of what the regulations require - often 25 years or longer. And, as you could guess, whatever language was agreed to in the contract will prevail over what is required by law.
Last: It is strongly recommended that study teams use the Rutgers Records Management Facility for long term storage of documents. Our experience has been that, in addition to having very reasonable costs, they are extremely customer-service focused, and very easy to use. You can rest assured that your documents will be stored securely and in compliance with applicable regulations, and, importantly, that they will be easily accessible for an audit, should that happen down the road.
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*Photo credit to Boston University Medical Center |
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VPN for EPIC use: Citrix (VPN) will be required to access EPIC while working outside of RWJUH. More info can be found here
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Want to make your life just a little bit easier?
Set up home screen widgets to get real time updates on subject statuses, SAEs, study timelines, and regulatory tasks that are due!
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- Ensure that you are on the Home Screen by clicking on the blue OnCore logo in the top left corner
- Under your user name in top right corner, click on the very tiny gear icon.
- The Home Screen Configuration page will open.
- Any widgets that have already been added to the Home Screen are shown in the column 1 and column 2 boxes at the top.
- Widgets that can be added to your homepage are listed at the bottom of the page.
- Select the [Add] checkboxes for any additional widgets you want.
- Click [Save].
- To change the order of position of the widgets, click any widget in column 1 or column 2 and use the green arrow buttons to move the widget up or down, or to a different column.
- Click [Save].
- Click the blue OnCore logo in the top left corner to navigate back to the Home Screen. Note: When you first add the protocols and subjects widgets to your home page, they will be blank. You will need to configure them to display items (see next section).
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Clinical Research Pet of the Month |
June’s RBHS Clinical Research Pet of the Month is Tallulah, companion to Randy Teeter (Director for the NJMS Clinical Research Unit.)
According to Randy, Tallulah, a 9-year-old, black domestic shorthair with a white locket, is a strict taskmaster and an unapologetic diva. She maintains strict rules of engagement and doesn’t hesitate to use her sharp “uñas” to maintain order among her subjects.
Tallulah regularly attempts to mimic a human sleep/wake schedule, a practice which often leads to failure. She also considers herself President of the Neighborhood Watch for Randy’s lower Manhattan neighborhood. From her windowsill perch, she quickly responds to unfamiliar stimuli emanating from the mean streets below.
Above it all, even with this demanding schedule, Tallulah manages to simultaneously be one of the most loving beasts on earth.
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