Data and Safety Monitoring Committee
Data and Safety Monitoring Committee (DSMC)
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) Data and Safety Monitoring Committee (DSMC) includes both the DSMC Monitoring Office and the DSMC Education and Training Office. The DSMC Monitoring Office is supervised by the DSMC Monitor Supervisor and the DSMC Education and Training Office is supervised by the DSMC Education and Training Manager. The DSMC Supervisor and the DSMC Education and Training Manager both report to the DSMC Administrative Director.
The DSMC Monitoring Office is responsible for the monitoring and auditing of all Interventional (Therapeutic and Non-therapeutic) institutional and NCI clinical trials for data validity, trial conduct, and adverse event (AE)/serious adverse event (SAE) reporting. The DSMC Education and Training Office is responsible for the onboarding and continual education of all Investigators, Clinical Research Coordinators (CRCs), Protocol Project Managers (PPMs), Regulatory Staff, etc. in the HDFCCC.
DSMC Monitoring Office
The DSMC Monitoring Office is composed of the DSMC Senior Monitors, DSMC Senior Auditors, and the DSMC Clinical Research Network Office (CRNO) Senior Auditor reporting to the DSMC Monitor Supervisor. The DSMC Senior Monitors and Auditors perform the real-time monitoring or semi-annual auditing of the institutional and NCI trials in the HDFCCC as per the NCI-approved HDFCCC Data and Safety Monitoring Plan (DSMP). The trials are either monitored/audited based upon the risk assessment algorithm from the DSMP.
Phase I/Pilot/Gene therapy/Vaccine therapy trials are typically monitored monthly, dependent upon accrual, and beginning within the first month of the initiation of enrollment. The DSMC approves all dose escalation decisions for UCSF Institutional Phase I trials within three business days after receipt of the Dose Escalation Request Form from the PI. The DSMC conducts real-time monthly monitoring of all treated study participants through the Dose Limiting Toxicity (DLT) period for Phase I/Pilot/Gene Therapy/Vaccine Therapy Institutional trials and conducts semiannual auditing of at least twenty percent of all enrolled study participants for Phase II and III Institutional and NCI trials. The regulatory files for all trials are audited on an annual basis for regulatory compliance. The DSMC also reviews planned interim analysis on institutional trials, evaluates external NCI and Industry Sponsor audits and assists with the development of Corrective and Preventative Action Plans (CAPAs), and evaluates any safety of study design concerns raised by the PI, Site Committee, the Protocol Review Committee (PRC), or the IRB. The DSMC Monitoring Office also provides audit preparation for Industry Sponsored Quality Assurance Audits, National Cancer Institute (NCI) Audits, and FDA Inspections.
If serious non-compliance determinations are adjudicated by the IRB, or if there are other significant safety issues within a study program, or staffing concerns that are affecting the safety of the study participants or data integrity of the trials for the PI in the HDFCCC study program, then the DSMC can request a mandatory hold on enrollment until adequate remediation is instituted by the PI. This may include the hiring and training of additional staffing, improved workflow processes, etc. in order ensure future compliance. The DSMC Will notify the Comprehensive Cancer Center Research Oversight Committee (CCCROC), PRC, and the IRB of the mandatory holds on accrual and will provide the DSMC’s remediation plan for the study program for the eventual reopening of accrual.
All Investigator-Initiated trials conducted at the HDFCCC must incorporate the Data and Safety Monitoring Plan (DSMP) Templates from the current NCI-approved HDFCCC DSMP in the institutional protocols to include both the delineation of responsibilities and a description of the data and safety review process. The PRC will not approve a protocol without the correct incorporated DSMP template. The DSMP templates for the various study types are provided within the NCI-approved DSMP. For questions on the DSMP, please contact the DSMC Administrative Director, John McAdams (John.email@example.com).
Policies & Procedures developed by the DSMC are located on the ITR Policies page.
DSMC Administrative Director:
John F. McAdams, MS, CCRP
DSMC Administrative Director
DSMC Monitor Supervisor:
Fred Fishman, BS, CCRP
DSMC Monitor Supervisor
DSMC Education and Training Office
The DSMC Education and Training Office is composed of the DSMC Education and Training Manager. The office is responsible for the onboarding and continual education of all the investigators and research support staff at the UCSF HDFCCC. The office also extends its services to investigators and research staff that are collaborating with the UCSF HDFCCC. The DSMC Education and Training Manager collaborates with the Clinical Research Support Office (CRSO) and Clinical Research Network Office (CRNO) to ensure their staff have the proper training, continual education, and training oversight required to perform their work. The DSMC Education and Training Manager also collaborates with UCSF as an institution to ensure that the HDFCCC is in compliance with all federal regulations, state laws, and institutional policies in conducting clinical research.
The DSMC Education and Training Office currently has the following training series/resources available:
- CRC Onboarding Series
- Regulatory Training Series
- Investigator Training
- Continual Education
- SoCRA Exam Prep
DSMC Education and Training Manager:
Amy Li, MPA, CCRP