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December 2011 - Issue #6
Clinical Clinical Research Coordinating OfficeResearch Coordinating Office
NewsletterNewsletter
Newsletter Features
Katie Wulff, New UWCCC
Assistant Director of
Clinical Research
WON Meeting, 4/20
CRCO Tips of the Month
PRMC
DSMC
Budget Compliance
OnCore Tips of the Month
Regulatory and Subject
Registration Data Entry
Spring 2013—Issue #11
Spring is here!
And with it, brings the Spring Wisconsin Oncology Network (WON) Meeting on Saturday,
April 20, 2013 at the Health Sciences Learning Center (HSLC) on the UW-Hospital Campus.
Please email the affiliatecoordinators@ uwcarbone.wisc.edu to RSVP , and let us know if
you are planning to stay for lunch! We hope to see you all there!
Introducing…...
Katie Wulff
Assistant Director of Clinical Research
We are pleased to introduce Katie Wulff, our new UWCCC Assistant Director of Clinical
Research. Katie earned both her Masters of Business Administration (MBA) and her
Masters of Science in Health Care Administration (MHA) from the University of Texas at
Arlington. She has experience in a variety of settings, including her work with the Uni-
versity of Texas Southwestern Medical Center in Dallas, MedTrials Inc., Methodist Dal-
las Medical Center, and Hologic, Inc. here in Madison. Katie started on January 28th
and has been integrating herself into all aspects of the UWCCC clinical research infra-
structure. We are so pleased to have her here and look forward to working with her
for a very long time to come!
A couple of fun facts to know about our new Assistant Director of Clinical Research :
Even though she has a slight drawl, she is not a native Texan, but rather originally
from Kansas.
She is extremely adverse to snow ( not having had prior experience with it!) and
doesn’t quite understand how we all manage in it! She’s also extremely happy that
Spring is in the air!
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December 2011 - Issue #6
CRCO Contact Info: Katie Wulff Assistant Director, Clinical Research [email protected] (608) 263-7898
Shari Zeldin CRCO Compliance Program Manager [email protected] (608) 263-8403 Belinda Buehl-Soppe CTRP/Education Coordinator [email protected] (608) 265-4543 Emily Jenner Data & Safety Monitoring Compliance & Monitoring Coordinator [email protected] (608) 262-9654 Kelsey Shay Compliance and Monitoring Coordinator [email protected] (608) 263-4877 Claire Kostechka PRMC Coordinator [email protected] (608) 263-0169 Billing Compliance:
Vielska Brautigam Budget Compliance Specialist [email protected] (608) 262-8980
Clinical Research
Coordinating Office
Reportable Events
Please review the Reportable Events listed in the
IRB Reviews tab in OnCore prior to generating a
Protocol Summary Report. All Reportable Events
must be entered into the database per the IRB
DSMC Reportable Event deSOP. If Reportable
Events are not entered accurately, you will re-
ceive a query from the DSMC Coordinator to
update the IRB Reviews tab and verify the num-
ber of Reportable Events. If you have any ques-
tions, please email
Update—OnCore Financials!
Training has been scheduled for staff that do billing slips through Oncore. The sessions will go over
Subject Visit Update Verification and electronic billing. The first training session will be held Monday,
April 1 at 11:00a.m. in 2121 HSLC. This will be followed by training sessions on Thursday, April 4 at
1:00p.m. and Wednesday, April 10 at noon in 2121 HSLC. Billing staff attendance is mandatory.
Please let Oncore Support know which training session you will be attending. If there are still out-
standing questions regarding Financials—please contact Vielska at 608-262-8980 or
September-October 2012—Issue #10
CRCO Office Updates
The following 2 email addresses are no longer being used:
Please delete these from your email address books and replace the addresses with
[email protected]. All documents will be updated to reflect the new email
address.
A special caregiver check is required for ALL personnel requiring direct patient contact.
To facilitate this process, please notify HR at the time a new employee is hired so that
they can get the ball rolling! If a staff member’s duties are revise at a later date to in-
clude direct patient contact, please be sure to give the CRCO at least one month’s no-
tice to ensure the correct paperwork can be filed in a timely fashion.
Spring 2013—Issue #11
Quality Assurance Reviews
Case Report Forms will now be reviewed during
Quality Assurance Reviews of Investigator-
Initiated Trials. Please ensure that your CRFs are
up-to-date prior to the QAR. If the study uses
eCRFs in OnCore, the Compliance Office will be
using the DM Console to query any discrepan-
cies. If your group receives discrepancies, a re-
sponse is required within 7 days. If the study
uses paper forms, please ensure that copies of
all forms are in the research chart
and these discrepancies will be via
email.
DSMC Tips
December 2011 - Issue #6
Page 3
New UWCCC Staff
Congratulations!
Please join us in recognizing Kris McDonald, one of the study coordinators for the Hema-tology Oncology DOWG, for her recent award through the Blood and Marrow Transplant Clinical Trials Network (BMTCTN). Kris was recently given a BMTCTN 2013 Coordinator award for her outstanding efforts coordinating BMTCTN trials. Kris was one of three coor-dinators recognized nationally at the American Society for Blood and Marrow Transplanta-tion (ASBMT) meeting for her excellent work. The Hematology Oncology group is very proud of Kris and her dedication and hard work. Great job Kris!!
September-October 2012—Issue #10 Spring 2013—Issue #11
Welcome our new PRMC Coordinator!
Please join us in welcoming Claire Kostechka, our new PRMC Coordinator. Claire comes to us from
MCW’s Pediatric Radiology Department where she managed research studies for the neuroradiol-
ogy division. She started at the UWCCC on February 4th and has been quick to learn the nuances
of her new role. She has already worked with many of our DOWGs and Clinical Research Groups in
facilitating protocol submissions to the PRMC and signing off in ARROW to forward PRMC
approvals.
Coreen Marklein
Payroll & Benefit Specialist
Isaac Akere
Fiscal Office Accountant
Lisa Werning
CTD2 Research Specialist
Lauren Howard Surgery
Program Manager
Nicky Kurtzweil Surgery
Regulatory Specialist
Adam Krajewski Surgery Research Coordinator
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December 2011 - Issue #6
OnCore Support Contact Info:
Stephine Wasielewski Manager, OnCore Support Office [email protected] (608) 263-2907 Divya Kudva OnCore Support Staff [email protected] (608) 262-6604 Arenda Nolan OnCore Support Staff [email protected] (608) 262-6604
Tip for Regulatory and Subject Registration Data Entry
The Automated MRN function in the PC Console > Management Tab should always be used for stud-ies that only collect limited demographic information, and should be invoked before any subjects are entered on the protocol in the database. Important Note: Protocols with billing must use full demo-graphic information and therefore cannot utilize the automated MRN function.
When the FIND function is used to enter a subject into a protocol in OnCore, the information for that subject populates in the Subject Console > Demographics tab from the subject information from oth-er protocols. Therefore, that information is connected to the subject on other protocols, and any-thing added or deleted on the demographics tab in your protocol will be deleted on all protocols throughout OnCore for that subject.
With that, information entered in the Demographics tab > Subject Comments field populates to all protocols as well; so only subject specific information should be added to this field. For example “Subject has Latex allergy”, “Subject is hard of hearing”, etc. Protocol specific comments should be entered in the On Study Tab > Comments field.
OnCore Support
Corner
OnCore Tip of the Month
September-October 2012—Issue #10 Srping 2013—Issue #11