2014 Fall Group Meeting – Dallas, TX
CRA Steering
Chair- Susan Stork
Tues. 9-16- 2014
4:00 p.m. – 7:00 p.m.
AGENDA
1. Susan Stork
a. Approve past July Steering minutes
b. Old Business
c. New Business
a. Recap the year
b. Future plans
2. Lisa Bomgaars/Shanila Faghfoor
a. Regulatory updates
b. Discussions regarding policies
3. Mini Devidas/ Sheila Hurley/ Steven Jong
a. Updates from SDO
4. Judy Everett
a. Updates from SDO
5. Lisa Beaverson
a. Updates from Biopathology Center
2014 Fall Group Meeting – Dallas, TX
CRA Education
Chair- Sally Muehle
Wednesday, 9/17/2014
7 a.m. – noon
2 p.m.- 6 p.m.
AGENDA
1. 7 a.m. Welcome to New CRAs/Mini- Networks - Barb Shepperd/Stephanie Badour
a. Tips for session attendance
b. Opportunity for CRAs to learn about Mini-Networks and join a network
2. 8 a.m. – noon
SoCRA Exam
3. 2 p.m. CRA Education
a. APEC14B1 – Dr. Peter Adamson/Lisa Beaverson
b. Update Biopatholgy Center – Lisa Beaverson
c. AOST1322 – Dr. Michael Isakoff
d. CRA Steering Chair Candidates – Sally Jones/Barb Shepperd
e. CRA CIRB (Central Institutional Review Board) Presentation – Jill Woodman
and Panel of experts
1. The purpose of this panel is to identify “checks and balances” for our
processes.
4. 5 p.m. – 6 p.m. Poster Presentations – Emily Owens-Pickle
Title: From Disaster To Triumph: A Qualitative Examination of Different Educational
Strategies; Authors: Jenna Weight, BA, Libby Heimler, BA, Julia Marino, MD, MS, Graham
Heimler, BS, Diane Olszewski RN, MN, CPHON, Carla Golden, MD; Institution: Children’s
Hospital and Research Center Oakland
Title: Home Medication Documentation: An Instrument to Make the Patient/Family an
Active Partner of the Research Process; Authors: Tiffany A. Klein RN BSN, Beth A.
Speckhart RN MS CPON, Sharon M. Rendleman RN, Karen S. Fernandez MD; Institution: St.
Jude Midwest Affiliate, Children’s Hospital of Illinois, University of Illinois College of Medicine
2014 Fall Group Meeting – Dallas, TX
Title: Development and Implementation of a Clinical Research Career Ladder; Authors:
Kristen M. Vangile, MPH, CCRP; Shanikwha June, MS, CCRP; Terrell Faircloth, CCRA,
Jaclyn Smith, MBA, CCRP; Rebecca Byram, MEd, Stephanie Tucker, MPH; Institution: Killian
Owen Curing Kids Cancer Clinical Research Office, Aflac Cancer and Blood Disorders Center
Title: Career Track for CRCs at an Academic Medical Center; Authors: Amanda Galster,
Lisa Johnson, Katie Mellskog, Ashley Schempp, Denise Windenberg; Institution: University of
Minnesota
Title: Towards Effective Childhood Assent for Pediatric Oncology Medical Research:
Physician and Parental Views; Authors: Leisa Haslerig, CCRP, Arlene King, CCRP, Jennifer
Keates-Baleeiro, MD, Avery Mixon, MD, Meghann McManus, DO, Manoo Bhakta, MD;
Institution: T.C. Thompson Children’s Hospital
Title: Real Time Toxicity Grading of Adverse Events: Engaging the Bedside Nurse in
Clinical Research; Authors: Tiffany Klein RN BSN, Sharon Rendlemen RN; Institution: St.
Jude Midwest Affiliate
Title: Measuring CRA Awareness and Involvement in COG Provided Resources for
Professional Development Opportunities; Authors: Jones, Sally CCRP, Woodman, Jill
CCRP, Owens-Pickle, Emily CCRP, Espirito Santo, Anelise RN, CCRP, Stork, Susan CCRP,
Borgerson, Dawn, RN, CCRP, Shepperd, Barbara, RN, CCRP, Badour, Stephanie, CCRP,
Lane, Ashley, CCRP, Muehle, Sally, CCRP; Institution: Washington University School of
Medicine, Ann and Robert H Lurie Children's Hospital of Chicago, Arnold Palmer Hospital for
Children, The Montreal Children's Hospital of the MUHC, Blank Children's Hospital, Toledo
Children's Hospital, Children's Hospital Colorado, BC Children's Hospital, Children's National
Medical Center, Rainbow Babies and Children's Hospital
Title: Legacy Map Creation in a Team of Pediatric Hematology/Oncology Nurse
Practitioners: Promoting Professional Development; Authors: Brittany Richardson, MSN,
RN, CPNP1, Katie Gettinger, MSN, RN,CPNP1, Emily Attig MSN, RN, PNP-BC1, Mandy
Drozda MSN, RN, CPNP, CPON2, Kelsie Hankins MSN, RN, CPNP-AC1, Monica Hente
MSN, RN, PPCNP-BC, CPON, BMTCN 1, Juliann Kiefer MSN, RN, CPNP1, Andrea Price
MSN, RN, CPNP2, Debbie Robinson DNP, RN, PPCNP-BC, CPON, 1, Ginny Schulz MSN,
RN, CPNP2, Debra Spoljaric MSN, RN, CPNP2, Alison Towerman MSN, RN, CPNP2,
Jennifer Wofford MSN, RN, CPNP, CPON2, Debbie Woods MSN, RN, CPNP, CPON2,
Caroline Mohrmann, MSN, RN, CPNP-AC2; Institution: 1St. Louis Children’s Hospital,
2Washington University School of Medicine, St. Louis, MO USA
2014 Fall Group Meeting – Dallas, TX
Phase 1 CRA
(Session closed to industry representatives)
Presenter – Phase 1/Pilot Consortium Operations Staff
Wednesday, September 17, 2014
9:00 a.m. – 11:00 a.m
AGENDA
1. Introduction – Thalia Beeles
2. Phase 1 Reporting Guidelines
3. Phase 1 Roster
4. OPEN
a. Full Slot Reservation System
b. Enrollment
5. Medidata RAVE
a. Data Submission
b. Query Management
c. FAQs
6. CTEP AERS Reporting
a.
b.
c.
d.
Definitions
AdEERs vs AERs report differences
Exceptions to expedited reporting
FAQs
7. New Protocol Highlights
2014 Fall Group Meeting – Dallas, TX
CRA Education Thurs
Chair- Sally Muehle
Thursday, 9/18/2014
7am – 10 am
4 pm – 6pm
AGENDA
1. 7 a.m. Q &A with a panel of CRA Steering, Study and Disease Committee CRAs
a. Discussion to include: opportunities for involvement & time
management /Q & A
2. 8 a.m.– CRA Education
a. ANBL1232 – Dr. Holly Meany
b. AALL1331 – Dr. Patrick Brown
c. AAML1331 (APML) – Dr. Matthew Kutny
3. 4 p.m.– Joint Nursing/CRA Session
a. AALL1131
b. ACNS0831
4. 5 p.m. - CTSU (Cancer Trials Support Unit)
Ravi Rajaram, CTSU Assistant Project Director
a. Presentation w/ Q&A
2014 Fall Group Meeting – Dallas, TX
CRA Education
Chair- Sally Muehle
Friday, 9/19/2014
8 a.m. – noon
AGENDA
8 a.m. – noon CRA Education
a. Partnering with Industry: A New Frontier in COG Clinical Trials/Gina Filley/
Allison Hale
b. CRA Poster Top 3 Presentations – Emily Owens-Pickle
c. Return of Results – Jim Bradley/Tina Bocking
d. Contracts and Funding – Maria Hendericks/Dori Triplett
e. AALL0932 AE Reporting – Ashley Lane
f. ANBL1221 AE Reporting – Dr. Rajen Mody/Dr. Julie Ruggieri Park
g. AALL1231 – Dr. David Teachey