Protocol development consultation, scientific and safety peer review, and study administrative monitoring are the responsibility of the Office of Protocol Development and Monitoring, located within Holden Comprehensive Cancer Center's (HCCC) Clinical Research Services (CRS). This office collaborates with the Clinical Research Services (CRS) in providing infrastructure for HCCC clinical investigators.
- Protocol development consultation and education.
- Coordination of biostatistical consultation with the Biostatistics Core.
- Development of data and safety monitoring plans
- Accrual monitoring.
- Bi-annual and quarterly data and safety audits.
- Administrative support of the PRMC and DSMC.
- Communication with regulatory offices for oversight of clinical research.
- Clinical trial data management and reporting.
Protocol Planning and Pre-review Committee (PPPC)
HCCC's CRS staff is available to assist investigators with the development of new investigator-initiated protocols. Pre-review and feedback on draft versions of the protocol reduces the need for modifications to obtain PRMC approval and/or begin study initiation after approval.
Protocol Planning and Pre-review Committee (PPPC) responsibilities include:
- Providing guidelines and templates for clinical research studies
- Ensuring that the protocol is written in a way that utilizes appropriate resources and personnel
- Ensuring consistency throughout various sections of the protocol (e.g., protocol narrative, study calendar, dose modifications)
- Coordinating development of protocol tools and case report forms for data capture
Investigators and their staff working on protocol development are encouraged to contact Protocol Development and Monitoring staff to schedule a meeting to discuss details regarding planning, pre-review and editing of the protocol, and the PRMC/DSMC review process. Investigators are also strongly encouraged to consult with HCCC's Biostatistics Core to receive assistance in the design and analysis of cancer research projects.
PPPC members and their review areas include the following:
- Michael Goodheart, MD
- Cena Jones-Bitterman, MPP, CIP, CCRP
Data and safety monitoring, PRMC review
- Marilyn Rosenquist, MS
Data and safety monitoring, DSMC review
- Carlie Etscheidt, RN, MSN
Data and safety monitoring, nursing resources, protocol logistics
- Mary Schall, RN
Research nursing resources
- Research Coordinator Representative
Varies by patient population
Administrative Office: 11510 PFPCena Jones-Bitterman, MPP, CIP, CCRP
Clinical Trials Research Manager
email@example.com Sarah Bell, MS
firstname.lastname@example.org Marilyn Rosenquist, MS
Clinical Research Safety Officer
email@example.com Brian Smith, PhD
firstname.lastname@example.org Gideon Zamba, PhD