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 Data and Safety Auditor (DSA) Supervisor and the DSMC Education and Training Office is supervised by the DSMC Education and Training Manager. The DSMC DSA 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.
The DSMC Committee has 13 voting faculty members, with staff representing the Site Committees, as well as a IDS Pharmacist and a Biostatistician. There is a faculty DSMC Chair and two Vice Chair for conflict of interest purposes or if the DSMC Chair is out of office. Additionally, here are 8 non-voting, non-faculty members of the DSMC, which include the administrative staff in the DSMC Monitoring Office and the DSMC Education and Training Office.
DSMC Monitoring Office
The DSMC Monitoring Office is composed of Senior Data and Safety Auditors, Junior Data and Safety Auditors, and the DSMC Clinical Research Network Office (CRNO)/Multicenter Senior Data and Safety Auditor reporting to the DSMC DSA Supervisor. The DSMC Auditors perform the real-time monitoring or 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 monitored based upon the risk assessment algorithm from the DSMP.
Phase I dose finding therapy trials are typically monitored prior to dose escalation request by the study team (for dose escalation trials) and other high-risk non dose finding studies are monitored on a quarterly basis. The DSMC approves all dose escalation decisions for UCSF Institutional Phase I trials within two business days after receipt of the Dose Escalation Request Form from the Primary Investigator (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 approves all safety lead-in cohorts for Phase II studies with these cohorts.
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 provide an annual DSMB Report for all multicenter and consortia studies and provides a review and adjudication on all SAEs at the DSMC Meetings, which occur on every other month basis. The DSMC Monitoring Office also provides audit preparation for Industry Sponsored Quality Assurance Audits, National Cancer Institute (NCI) Audits, and FDA Inspections.
- NCI Approved DSMP (v 18 Mar 2024)
- DSMP Templates for Protocols (v 15 Aug 2024)
- DSMC Roster (v 7 Aug 2024)
- DSMC 2024 Meeting Calendar (v 15 Apr 2024)
- DSMP Approval Letter
Policies & Procedures developed by the DSMC are located on the Policies page.
DSMC Administrative Director
John F. McAdams, MS, CCRP
P: 415-476-8496
E-mail: [email protected]
DSMC Data and Safety Auditor Supervisor
Melody Gawliu, BA, CCRP
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:
- DSMC Education and Training website (MyAccess login required)
- CRC Onboarding Series
- Regulatory Training Series
- Investigator Training
- Continual Education
- SoCRA Exam Prep
DSMC Education and Training Manager
Amy Li, MPA, CCRP
P: 415-502-9623
E-mail: [email protected]