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 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, Auditors, and CRNO Senior Auditor 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 prior to dose escalation request by the study team (for dose escalation trials) and quarterly (for non-dose escalation trials). 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 annual 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 a biennial 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 and Monitoring Committee (PRMC), 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), PRMC, 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 PRMC 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 ([email protected]).

NCI Approved DSMP (v 16 Sep 2021)

DSMP Templates for Protocols (v 18 Mar 2024)

DSMC Roster (v 16 Nov 2023)

 

Policies & Procedures developed by the DSMC are located on the Policies page.

DSMC Administrative Director:
John F. McAdams, MS, CCRP
DSMC Administrative Director
P: 415-476-8496
E-mail: [email protected]

DSMC Monitor Supervisor:
Melody Gawliu, BA, CCRP
DSMC Monitor Supervisor
P: 415-502-5329
E-mail: [email protected]

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:

Contact Information:

DSMC Education and Training Manager:
Amy Li, MPA, CCRP
P: 415-502-9623
E-mail: [email protected]