Our previously published newsletters are available on our website. You can find them here.
|
|
WCG Webinar
Better Together: How to Strengthen Sponsor and Site Partnerships - A Panel Discussion
August 25th, 2022
12 pm EST
Clinical trial starts are at an all-time high, and as trials continue to grow in complexity and number, the need to develop better collaboration and communication between sponsors and sites to overcome key industry challenges is evident. But what do effective relationships between sites and sponsors really look like, and how can these relationships be built and maintained?
In part eight of our “Future of Research Sites” webinar series, we are excited to bring together representatives from research sites and sponsors to share their experiences and perspectives on how sites and sponsors can improve their relationships, boost collaboration, and drive innovation in research.
Join us on Thursday, August 25th for a 45-minute webinar where our speakers will:
- Share a market analysis of the site & sponsor landscape
- Provide real-world insights on how to build and maintain good sponsor/site relationships
- Discuss the needs of both sites and sponsors in the shifting clinical trial landscape
- Share perspectives on how research sites and sponsors can collaborate to drive innovation
Offer innovative solutions that research sites and sponsors are implementing to overcome challenges
|
|
NIH's Data Management & Sharing Policy |
|
A joint presentation by Rutgers Research and Sponsored Programs and University Libraries will be held:
September 21st
12 – 1 pm
They will provide a summary of the new policy and discuss resources to help faculty comply. Register here.
Overview:
NIH’s Data Management & Sharing (DMS) Policy, takes effect on January 25, 2023. NIH requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan.
Investigators are required to:
-
Submit a Data Management and Sharing plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.
-
Comply with the Data Management and Sharing plan approved by the funding Institute or Center (IC).
More information and details on compliance will be shared.
Targeted audience: Faculty and Administrative Staff.
|
|
ACTS Professional Development Roundtable |
|
Increasingly, the most impactful science is done on large, multi-disciplinary teams. But how well do we understand the factors that make research teams more – or less – effective? In this second, highly participatory installment of the ACTS Professional Development Roundtables, we will address a series of questions related to team science, including the following:
· What specific competencies should scientists have in order to work well on teams?
· What collaboration challenges have you experienced and how might these competencies help to address them?
· How can we best assess and develop team science competencies?
We will discuss team science competencies, map them to collaboration challenges we have experienced, and hear from team science experts Wayne McCormack, PhD and Jeni Cross, PhD, about new developments in the field. In the course of the roundtable, we will collaboratively build a repository of tools and assessments to enhance team collaboration and productivity. You will leave with a set of clearly delineated team science competencies and ideas for building and assessing these skills. Please join us, bring your best team science resources to share, and learn from your colleagues!
Linked you will find the article that will serve as the springboard for our discussion. We look forward to seeing you!
|
|
New Monthly Reports from OnCore |
|
In early August, the CTO began distributing monthly reports from OnCore to all RBHS clinical research programs/groups for the studies they manage. We hope that these reports will provide a useful snapshot of the data in OnCore and will help with managing your programs.
We ask that study teams review their reports at their earliest convenience, and go in to OnCore to correct any errors or missing information as soon as feasible. The reason this is important is because this data will feed into the quarterly reports that will be provided, starting later this year, to PIs and Department Chairs as well as senior RBHS leadership so they have a means to assess research productivity across the enterprise.
Please let us know if you did NOT receive your report, or if you have questions or concerns about the process.
|
|
Regulatory Tip of the Month |
|
21 CFR Part 11 Compliant DocuSign is now available for RBHS clinical research teams
Are you confused about when you need to use the 21 CFR Part 11 compliant version of DocuSign versus when the regular version will suffice? Join the club, because it’s complicated. Fortunately, both versions are available to RBHS clinical research teams, and we have resources to help you learn how to use these tools. To start, you may want to check out the YouTube tutorial (link below) and also visit our website
We have noticed a new trend whereby more industry sponsors are requiring 21 CFR Part 11 compliant signatures from PIs on clinical trial agreements, and we also have noticed that this has sometimes led to delays in getting contracts executed. The CTO will be happy to set up a quick zoom to walk your PI through the signature process if this would be helpful. Please reach out either by e-mailing us or by setting up a support session here
|
|
TIN Introduction &
Recruitment Toolkit
|
|
Many resources are available to clinical researchers at RBHS through our Clinical and Translational Science Award (CTSA), such as the Trial Innovation Network (TIN). The TIN is comprised of members from other CTSA institutions, and seeks to develop innovative solutions to the roadblocks we all face in conducting clinical research. You are encouraged to visit the TIN website and create an account to see what they have to offer.
An example of one of the guides recently developed is a Toolkit for developing professional and eye-catching recruitment and retention materials.
|
|
RWJMS Clinical
Research Workgroup
September 19th 2022
12 pm EST
Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more!
|
|
Please join us in congratulating Yanille Taveras on her promotion to Research Program Manager at the NJMS CRU! Yanille has worked very capably as a research coordinator and regulatory manager for the CRU, and is well positioned for this new role. Yanille will take the helm of the CRU from Randy Teeter, who is retiring later this month. |
Randy’s presence in the CRU, and throughout NJMS and UH, will be deeply missed. Throughout his 8 years at NJMS, Randy expertly juggled every facet of clinical research and made it look effortless. His breadth of knowledge, as well as his kind and thoughtful manner have been a gift to all of us. He’s leaving the CRU a better place, and we are grateful for the wonderful foundation he provided for Yanille to continue to build on. |
|
Confused by queries in OnCore? You aren't alone.
Here is a quick run-through of how to handle a query in submission console.
Prior to SRB approval for initial ePRMS submissions and change reviews, the CTO Coordinator may have questions about the submission and have the ability to enter a query. You will receive an email notification when the submission has been queried.
At any time, you can view whether a response is required in the Active tab of the Submission Console.
|
|
1. Click the Detail link for the submission in the Query Detail column of the Response Required section. The Query Detail page is displayed. |
|
2. Review the Queries.
3. To make changes or updates to the submission, click the Back to Submission button, then the Update button as needed.
4. Once the issues have been addressed, return to the Query Detail page by clicking the Query Detail button.
5. In the Inquiry Details page, click the Edit link next to the Query. The Response box is displayed at the top of the page.
6. Type a message (up to 1000 characters) detailing how the Query was addressed. If more information is required, you may attach a document addressing the query. Then, click the Submit button to save the response.
7. When all the Queries have been addressed, click the Respond button to return the submission to the Coordinator. This will move the submission to the Pending tab.
|
|
Clinical Research Pets of the Month |
|
August’s RBHS Clinical Research Pets of the Month: Mila’s Menagerie
Congratulations to Mila Dunbar, Executive Assistant for RITMS! It turns out that Mila has a second career rescuing animals. First, we have Spike (top left), who, at 16 who, with rotting teeth, was about to be surrendered to a shelter to live out his remaining years. Iris, the eldest at 19 (top right), was once a spry barn hayloft kitten. Despite her advanced age, she still eats like mad and can be found frequenting the outdoors in the shade.
Next, meet Seal (middle row, left) and Bruce (bottom left, brothers from a litter found in a Monmouth County Racetrack hayloft. Seal weighs in at 18 pounds and watchfully guards the house from the driveway. Bruce is now missing a leg but that doesn’t seem to hold him back.
|
|
Alex and Tess, the lone canine members of the menagerie, are both hound mixes adopted from Mississippi and Tennessee respectively. Hounds are notorious for their hunting skills, and these two are no exception. Alex has a penchant for deer and Tess is the chipmunk master.
Now for the junior members of the pack. Alanna Rose (middle row, right) is 4 and is easily the princess of the group (notice the pillow). As a kitten, she was found in pile of hay in a barn. She had an early brush with danger when a cow grabbed her up in its mouth with the hay, but fortunately spit her out and gave her a second chance at life! And finally, we have Stuart Wallace (lower right) who is 3 years old and began his kittenhood under a porch where he was subsequently rescued.
Congratulations, Mila! On behalf of cats and dogs everywhere, we thank you for opening your home and your heart to those in need.
|
|
|
|
|
|
|
