July 2022 Edition
Our previously published newsletters are available on our website. You can find them here.

We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.
Upcoming Events
RWJMS Clinical
Research Workgroup
Monday, July 18th, 2022
1:00 PM
Our monthly meeting for the RWJMS clinical research staff will be discussing EPIC, OnCore, Deep6, ClinCard, and more!
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
Regulatory Tip of the Month
Calibration of equipment used in conducting clinical trials

If your job entails working with study monitors, you have probably been asked to produce proof that your clinic equipment (for example, vital signs equipment, scales, ECG machines, centrifuges, etc.) has been calibrated on a regular basis. This requirement can be traced back to the FDA regulations and helps to assure that data collected is valid and accurate.

Inspection/Calibration must be done by a trained and qualified individual using acceptable standards, and must also be documented appropriately. Annual inspections are the norm, unless the equipment manufacturer’s instructions suggest more frequently. 

If the equipment that you use is owned by the hospital, chances are, there is already a process in place to assure that this is done. But, resources are available should you need to arrange for annual equipment inspection/calibration yourself. We are aware of two Rutgers vendors that RBHS clinical research teams have been using: Med-Equip and ISS Solutions. More information is available from Rutgers MarketPlace.  
Introducing Vitalief
Rutgers has recently engaged Vitalief as a new staffing solutions partner. Vitalief specializes in clinical research personnel, and can supply part-time or full-time, temporary and permanent employees who have training and experience in clinical research. For more information, please visit https://vitalief.com/ or contact Nancy Reilly reillyna@rbhs.rutgers.edu
IRB Documentation in OnCore
OnCore is very smart, and sometimes, a little too smart. If you are trying to open a study to enrollment, precise documentation of IRB approval in OnCore is key. Follow this link to find an essential and easy-to-follow guide to ensuring your study’s IRB & Open to Accrual statuses are accomplished in a timely and headache-free manner. We think you’ll want to bookmark this one!
RWJMS Corner
Interested in remote monitoring through EPIC? Click here for a tip sheet!
NJMS Corner
Additional interfaces between EPIC and OnCore are on the horizon for NJMS. Stay tuned for more information!
OnCore Quick Tip:
Did you know Advarra has many training manuals available at your fingertips to help walk you through many of the common workflows? 

On any page in OnCore, click on your name, then select Help, select the Learning Portal. 
Once on the learning portal, click Training Manuals, then 2022, and the list of manuals are available.
Clinical Research Pets of the Month
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu
July’s RBHS Clinical Research Pets of the Month are Piper, Brucie, and Blue, fur children of Rebecca Freiday (Financial Assistant for the RITMS Clinical Trials Office).

Brucie, a large standard beagle who is at least 13 years old, is the oldest of the pack and is a rescue from Virginia. He only has three legs due to having been found caught in a trap. The leg was severely injured, infected, and needed to be amputated. He was a young dog when it happened and has adjusted very well. He still goes hiking (though not as long or as strenuously as in his younger days), and can get up to a pretty impressive sprint to chase a strange cat! Brucie’s favorite activities include cooling off in sandy shallows, snoozing in the sun or on the couch cuddled up with his pack, doing a happy beagle dance while waiting for breakfast, or best of all visiting his grandma where he gets lots of treats!
 
Piper is a 3-year-old white “sheprador” (German Shepherd x Labrador Retriever), and is one of the few (and certainly one of the best) impulse decisions Rebecca has ever made. She and her husband went to donate cat food to the local shelter and walked out with a cute, extroverted 8-week old puppy. Piper is sweet, gentle, affectionate, and generally well-behaved after lots of training! She loves being with her people, going on family hikes where she can keep a close eye on her “flock,” doing water retrieves on hot days, going on car rides, and watching the neighborhood from the kitchen window with her sister Blue (earning her nickname “Princess Peep”).
 
Blue, aka Captain Bluebell, is a 1.5-year-old blue tabby and joined the family after Rebecca emphatically and repeatedly told her mother that no, she was not going to adopt any of her mother’s neighbor’s cat’s kittens. Blue is a gregarious and playful cat. She enjoys jumping on the counters and tables when she thinks her parents aren’t around, pouncing on her sister Piper, hunting stray bugs, doing kitty parkour around the house at high speed, and interrupting Rebecca’s Zoom meetings. She is also a fan of looking out the window and especially likes spending hours watching the chipmunks, squirrels, birds, and other backyard visitors. After all that activity, she likes to lounge around or cuddle up to her canine siblings or mom.