UCCC Protocol Quality Assurance and Safety Committee
The University of Colorado Cancer Center’s Quality Assurance and Data Safety Monitoring Plans help ensure safety and ethical treatment of all human subjects participating in research and verify that all collected data is accurate, complete, valid and has integrity.
The UCCC Protocol Quality Assurance and Safety Committee (PQASC):
- oversees all aspects of QA/DSM within the UCCC Clinical Investigations Core
- reports to the UCCC Executive Committee and the Colorado Multiple Institutional Review Board (COMIRB)
- oversees reporting of adverse events and SAEs to sponsors and federal agencies such as NCI AdEERs.
The PQASC Education Committee identifies, develops and offers a variety of instructional activities to CIC staff, Principal Investigators and co-Investigators to improve knowledge of and compliance with clinical trials management standards
Collaboration
UCCC CIC collaborates with COMIRB, UC Denver Associate Vice Chancellor for Compliance, the School of Medicine Clinical Trials Advisory Committee , University of Colorado Hospital Research Review Committee and others to make the clinical trials process more efficient and accurate.
Committee Members
| Name |
Expertise |
| Anthony Elias, MD, Co-Chair, UCCC AD Clinical Research |
Medical Oncology |
| Madeleine Kane, MD, PhD, Co-chair, UCCC CIC Medical Director |
Medical Oncology |
| Jennifer Maitlen, RN, BSN, UCCC CIC Regulatory Affairs Team Leader |
CIC |
| Tim Byers, MD, UCCC Deputy Director |
Public Health |
| Zung Vu Tran, PhD |
Biostatistics |
| E. David Crawford, MD, UCCC AD |
Surgical Oncology |
| Brian Kavanagh, MD, UCCC PRMC Director |
Radiation Oncology |
| Anna Baron, PhD |
Biostatistics |
| Virginia Borges, MD |
Medical Oncology |
| Caroline Jamison, PQASC Coordinator |
CIC Regulatory Team |
| Astrid Elder PhD, Sr. Regulatory Analyst |
COMIRB |
| Lia Gore, MD |
Pediatric Oncology |
| Han Myint, MD, Director, Heme Malignancies |
BMT |
| Andrea Buchmeier, CCRC, UCCC CIC Clinical Director |
CIC |
| Ron Brauch, BS |
Pharmacy |
| Bernadette Pistone, PhD, Co-Director COMIRB |
COMIRB |
| Fleta Johnsen |
Lay Member |