Clinical Oncology Research Administration & Office of Regulatory Compliance

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Two committees oversee clinical research within the UCLA Jonsson Comprehensive Cancer Center: the Internal Scientific Peer Review Committee (ISPRC) and the Data Safety Monitoring Board (DSMB). Proper conduct of clinical trials in oncology is ensured by the Internal Quality Assurance Program, established in 1986.

Internal Scientific Peer Review Committee

The Internal Scientific Peer Review Committee (ISPRC) reviews clinical oncology protocols conducted by Cancer Center investigators. Drs. John Glaspy and Albert Lai serve as Co-Chairmen of the ISPRC. Under their direction, the committee reviews the required elements of the clinical protocol, statistical applications and other factors such as adequate research staffing, any competing trials, well-constituted data collection forms and utilization of other Cancer Center resources.

ISPRC New Study applications are submitted via the CAFÉ portal. Only electronic submissions are accepted.

Data Safety Monitoring Board

In response to the National Cancer Institute mandate, the UCLA Jonsson Comprehensive Cancer Center Data Safety Monitoring Board (JCCC DSMB) was constituted in January 2001 and meets monthly. The JCCC DSMB reviews all Serious Adverse Events (SAEs) occurring in Cancer Center protocols. In addition, the JCCC DSMB serves as the DSMB for institutional research studies at UCLA that do not have an external DSMB.

The JCCC DSMB helps to ensure that adequate safety monitoring will be carried out for all cancer interventional trials offered at the Cancer Center. The DSMB oversees the implementation of the data monitoring plans approved by ISPRC and on file with the Cancer Center. The chairman of the JCCC DSMB is Dr. Sven De Vos.

DSMB New Study applications are submitted via the CAFÉ portal. The DSMB application is the same application as the ISPRC application. When JCCC DSMB oversight is requested, additional DSMB related questions appear in the application. Only electronic submissions are accepted.

SAEs are submitted via OnCore.

Quorum permitted, DSMB meetings are held on the first Tuesday of every month except when the meeting day is after a holiday. The deadline for submissions is two weeks prior to each meeting as noted in the DSMB Meeting Schedule (2020) link above. 

Internal Quality Assurance Program

The Jonsson Cancer Center has had a long-standing Internal Quality Assurance Program (IQAP), beginning in 1986, to ensure proper conduct of clinical trials in oncology and, in so doing, safeguarding the rights and welfare of the study subjects. The internal compliance program is responsible for establishing an effective mechanism to promote proper adherence to all applicable local, state and federal laws, as well as specific program or cooperative group requirements by all researchers involved in oncology clinical research. The Office of Regulatory Compliance executes the Internal Quality Assurance Program.

The IQAP includes:

  • Performance of prospective monitoring and retrospective auditing of active trials to ensure regulatory and protocol compliance
  • Ensuring proper patient management per protocol and to ensure patient safety
  • Assisting principal investigators, sub-investigators and all clinical trial study team members by consulting on problems identified during any monitoring or auditing reviews
  • Educating and continually updating the research community regarding clinical research requirements

Submissions

The Cancer Center utilizes a single New Study Submission application for both ISPRC review and DSMB oversight requests. The Cancer Center ISPRC/DSMB New Study Submission application is submitted via the CAFÉ portal.

The CAFÉ application can only be accessed from within the MEDNET network or via VPN and by using your AD credentials. Only electronic submissions are accepted. Contact CORA@mednet.ucla.edu with any questions. 

Office Location
UCLA Jonsson Comprehensive Cancer Center
Clinical Oncology Research Administration
Office of Regulatory Compliance
700 Tiverton Avenue,
1-940 Factor Building
Los Angeles, CA 90095
Mail Code: 178121

Contact Information

Main Office
Phone: (310) 794-8742
Fax: (310) 794-8772

Maggie Lindenbaum
Director, Clinical Oncology Research Administration and Office of Regulatory Compliance
(310) 794-5788

Allan Derrick Udarbe
Manager, Office of Regulatory Compliance
(310) 794-5218

Colleen Mathis
Compliance Officer, Office of Regulatory Compliance
(310) 206-4051

Madelene Chaaban
Compliance Officer, Office of Regulatory Compliance
(626) 396-2989

Mark Glover
Reporting and CT.gov Registration Coordinator
(310) 794-8742

Marsha Noeline
ISPRC Specialist, Clinical Oncology Research Administration
(310) 794-5218

Jorge Huezo
DSMB Specialist, Clinical Oncology Research Administration
(310) 794-1852

Gina Hawkins
Quality, Performance and Training Coordinator
(310) 794-8757