Data Safety Monitoring Board
The UCLA Health Jonsson Comprehensive Cancer Center Data Safety and Monitoring Board (JCCC DSMB) was constituted in January 2001 and provides data and safety monitoring services for Cancer Center interventional, institutional studies at UCLA that do not have an external DSMB. Cancer Center oversight includes review of studies prior to initiation to ensure appropriate safety data reporting and statistical analysis plans and safety measures are in place prior to approval. The Cancer Center further verifies the institutional trials have appropriately reported safety and data outcomes, as well as are compliant with state and federal regulations throughout the execution of the clinical trial. The JCCC DSMB also reviews all Serious Adverse Events (SAEs) occurring on studies with DSMB oversight. The chairman of the JCCC DSMB is Dr. Sven De Vos.
The compliance team from the Office of Regulatory Compliance (ORC) executes compliance oversight on behalf of the DSMB. The ORC is a team of qualified and trained Compliance Officers and administrators whom monitor, audit and review patient eligibility for institutional trials. The risk score approved by the DSMB and outlined in the Data & Safety Monitoring Plan regulates the frequency and amount the trials are monitored and audited.
In addition to Compliance Officers responsible for the oversight, monitoring and auditing of institutional trials utilizing the JCCC DSMB, the ORC may also audit any cancer-related clinical trial conducted at UCLA regardless of sponsor type to ensure Cancer Center oversight of compliance and data integrity of all other trials conducted at UCLA.
Meetings and FAQs
DSMB meetings are held on the first Tuesday of every month except when the meeting day is after a holiday, in which case the meeting is held the second Tuesday of the month. The deadline for submissions is two weeks prior to each meeting as noted in the DSMB Meeting Schedule link above.
Submissions
Initial Review
The Cancer Center utilizes a single New Study Submission application for both ISPRC review and DSMB oversight requests. The JCCC New Study application is submitted via the CAFE portal. Only electronic submission is accepted. When JCCC DSMB oversight is requested, additional DSMB related questions appear in the application. DSMB and ISPRC review occur in parallel upon submission of the JCCC New Study application.
Summary Reports
Summary reports provide the DSMB with a summary of pertinent data related to the progress of the study including accrual, safety updates, protocol revisions, deviations, adverse events and general updates. The template above covers all required elements of a Summary Report. Summary reports are required quarterly, semi-annually or annually depending on the DSMB assigned risk level. The study's initial approval notice confirms the assigned Risk Level and frequency of Summary Reports and monitoring.
Serious Adverse Event (SAE) Reporting
SAEs must be submitted to the DSMB via OnCore within 10-days of awareness and 2-days of awareness if a death, regardless of attribution (related or not-related) to study intervention or study participation. See guidance above for submission steps in OnCore.
Single Subject Exception Request
By policy, single subject exceptions to study eligibility are not approved by the JCCC DSMB.
Participating Sites on an Investigator-Initiated Multi-Site Study
Participating sites on an Investigator initiated multi-site study require approval by the DSMB prior to activation of the participating site. To initiate the review of a participating site, download and complete the JCCC Multisite agreement for each site. The agreement includes a description of the requirements and documents that you should be submitted to the JCCC DSMB.
Manuscript or Abstract Reviews
Draft manuscripts (and abstracts or other publications that include data from the study) require DSMB review. Investigators can submit manuscripts (and abstracts or other publications that include data from the study) in parallel with the submission to the journal or conference. The two submissions do not have to be in sequence.
JCCC Data and Safety Monitoring Plan (DSMP) and Protocol Templates
If the Investigator did not utilize the JCCC Interventional Protocol Template, and still needs to incorporate the JCCC DSMB requirements in the study protocol, investigators generally do as follows. For sections related to “AE reporting and documentation,” “Data Safety Monitoring,” and “Monitoring” insert language from the JCCC Protocol Template (see below) into the study specific protocol, and file a copy of the JCCC Data Safety Monitoring Plan (DSMP) along with the protocol in the TMF and ISF. You could choose to append the DSMP to the protocol, but it is not required.
- JCCC DSMB Protocol Template (interventional)
- Adverse Experience Reporting and Documentation (section 11, pg 19-24)
- Data Safety Monitoring (section 14, pg 26)
- Monitoring (section 16.6, pg 28)
All other sections of the DSMB Protocol Template are provided as a guide and can be used when appropriate for the study. If a particular section is not relevant to a study, the Investigator can opt to enter “Not Applicable” with a reason, to demonstrate that the section was at least considered, rather than omitting the section all together. Ultimately, the JCCC DSMB is not looking for exact use of the JCCC DSMB Protocol Template, but it will review the language in the study specific protocol for alignment with the JCCC DSMP and sound design of the study and statistical analysis plan.
If your study protocol requires more specific guidance, please send your inquiry to [email protected] or [email protected] and a team member will connect with you.
Training
DSMB Orientation for Investigators and Staff is required training for all new studies under JCCC DSMB oversight. The DSMB Initial Approval Letter instructs study teams to contact their assigned compliance officer to schedule this required training. DSMB orientation training for new team members after study initiation may be requested at any time through the JCCC Clinical Research Unit Training unit at [email protected] (JCCC Quality Performance & Education).
Questions and DSMB Submission Support
The Cancer Center's Clinical Oncology Research Administration (CORA) team supports administrative activities for the JCCC DSMB. Any submission questions should be directed to [email protected].
Jorge Huezo
DSMB Specialist, Clinical Oncology Research Administration
(310) 730-8509
Maggie Lindenbaum
Director, Clinical Oncology Research Administration and Office of Regulatory Compliance
(424) 440-0438