About Clinical Research Support Office
Clinical Research Support Office
The Clinical Research Support Office (CRSO) is one of the units in the Investigational Trials Resource (ITR); it is divided into 4 units:
- Early Phase Clinical Trials Unit
- Research Personnel Unit
- Finance Unit
- Protocol Development and Regulatory Unit
The CRSO provides the Helen Diller Family Comprehensive Cancer Center (HDFCCC) with a central core of personnel with expertise in all types of clinical trials management, including protocol project managers (PPMs), protocol development and trial design, clinical regulatory affairs, UCSF compliance and financial management. The CRSO supports investigators in the conduct of cancer-related therapeutic or nontherapeutic clinical trials, with an emphasis on institutional (investigator-initiated) studies.
The objectives of the CRSO:
- Improve time to protocol activation for industry, cooperative group and investigator-initiated* clinical trials
- Increase the quantity of new investigator-initiated clinical trials
- Improve the quality of existing and new investigator-initiated clinical trials
- Facilitate the translational research efforts of the HDFCCC by providing assistance in streamlined protocol development, protocol activation, implementation and data capture
- Provide infrastructure for the conduct of early phase clinical trials
- Provide central oversight of research personnel, including initial and ongoing training, education, monitoring, and mentorship
- Increase the participation of volunteer subjects in clinical trials with an emphasis on diversity
- Serve as the central office of record for all clinical trials conducted at the HDFCCC
For more information about the CRSO, you may contact the CRSO Director Charalambos (Babis) Andreadis, MD, MSCE.
Early Phase Clinical Trials Unit
The Early Phase Clinical Trial Program is designed to offer novel therapies to Stage IV cancer patients who otherwise have few treatment options or have tumors that might be best treated with targeted therapies. Solid tumor oncologists, hematologists, neuro-oncologists, pathologists as well as nurse practitioners, study coordinators and a project manager are all part of the Early Phase Program team. This team works with pharmaceutical companies and other researchers, facilitating drug development by applying laboratory results to human clinical trials. The goal is to develop new, effective drug therapies for the treatment of solid tumor and heme malignancies.
The Early Phase physicians have access to generalized and specialized imaging services either within walking distance of the building where the clinical trials are conducted and/or across the multiple UCSF campuses.
The Early Phase Program utilizes space in the Mt. Zion and Parnassus Clinical Translational Science Institute (CTSI) where study visits are conducted and treatment is administered. At each CTSI location there are research trained nurses who administer the study treatments, laboratory technicians and a sample processing lab with freezer storage capability.
The Early Phase Clinic, based at the Mount Zion campus, is the gateway for a patient to receive information about the Early Phase clinical trials appropriate for their particular cancer type. Patients can be referred to the Early Phase Clinic by outside physicians, by UCSF oncologists, or self- referral.
A consultation appointment with an Early Phase physician can be made by calling 415-885-7796. The practice manager will instruct the patient about what medical records should be available to the Early Phase physician at this consultation appointment. A complete physical exam will be performed as well as a thorough review of the patient medical records. If appropriate, the patient will be offered a clinical trial and a sample consent form will be given to the patient to take home to review and discuss with family members and other medical providers, as the patient desires. Once a patient decides that he or she wants to be considered for participation, a screening appointment will be arranged to determine if the patient meets the protocol eligibility requirements.
More information can be obtained by calling the Early Phase Protocol Project Manager at 415-514-8755.
Research Personnel Unit
The Research Personnel Unit provides:
central oversight of research personnel (clinical research coordinators or CRCs, data managers or DMs, and Lead CRCs)
- supervises the hiring of new CRCs
- supervises the Lead CRCs in each program, who in turn supervise the CRCs of each program
- monitors certifications for new personnel (CITI human research protection, ethics and security, HIPAA, IT and email security, and blood borne pathogen and infection control for non-nurses)
initial and ongoing formal training, education, monitoring, and mentorship
- trains all Lead CRCs to perform standardized performance issue evaluations
- conducts an ongoing personnel review and evaluation process
- maintains an instructional plan for all new hires in the HDFCCC, which includes training documentation as well as the establishment of performance or competency standards
- conducts four-week “on-boarding” period that provides training in all university-required certifications, email etiquette, working in the medical center, research billing, privacy issues, Good Clinical Practices, electronic medical records, and OnCore use
- conducts multiple classes on GCPs in research based on the Code of Federal Regulations, Informed Consent, Adverse Events, Data Collection and Entry and Overview of Protocol approvals at the HDFCCC
- standardized procedures and policies for research personnel
- hiring and performance appraisal input on research nurses and nurse practitioners
- GCP training to all research nurse hires, with particular emphasis on RNs without research experience
- assisting staff and investigators with preparation prior to (and following) external audits
Research Personnel management meets regularly with the Lead CRCs to discuss performance issues, provide training in HR procedures and coaching for success, and to disseminate CTMS entry requirements, SAE reporting, and other reporting procedures. Under the direction of the Research Personnel Unit, the Lead CRCs form a working group charged with updating standardized procedures to maintain best practice for GCPs and keep program procedures consistent across the HDFCCC. This Lead CRC working group has developed a Training Resource Portal, modified the current GCP training program to include “Managing Multi-center Trials” and “Train the Trainer” sessions, and addressed training or operational issues that arise from monitoring reports or audits.
The Research Personnel Unit leadership participates in:
- Biweekly CRSO Leadership Meeting
- Data Safety Monitoring Committee (DSMC)
- Clinical Trials Informatics Process Improvement
- Cancer Registry Committee
- EMR Clinical Trials Working Group
- Multicenter Trials Taskforce
- Disease Site Committee meetings, particularly with regards to assisting staff and investigators with preparation prior to (and following) external audits.
The Finance Unit is responsible for managing the entire pre-award process for investigator-initiated and industry sponsored clinical trials.
The Finance Unit provides the following services:
- Medicare coverage analysis (MCA)
- Develop protocol-specific budgets and negotiate those with sponsors
- Assist the PI in budgeting the costs for investigator-initiated* trials
- Ensure the use of standardized costs for research procedures and studies across multiple programs
- Develop agreements with sponsors via collaboration with the Office of Sponsored Research (OSR)
- Ensure that complete contracts are executed accurately
- Develop and update clinical trial budget and contract templates as necessary
The Finance Unit utilizes prioritization data determined by the different Disease Site Committees to establish the priority order for processing MCA, budgets, and contracts.
For more information about the Finance Unit and its services, contact Erica Boston.
Protocol Development and Regulatory Unit
The Protocol Development and Regulatory Unit is divided into three divisions:
The Protocol Development and Regulatory Unit provides comprehensive regulatory support to ensure compliance with the UCSF Committee on Human Research (CHR), HDFCCC Protocol Review Committee (PRC), the NCI, FDA, DOD, and peer reviewed sponsors or foundations.
For investigators who plan to initiate an institutional investigator-initiated clinical trial (non-therapeutic or therapeutic) with the CRSO, they need to work with the appropriate program’s Protocol Project Manager to begin the process. More information and instructions on the process are described below.
For more information about the Protocol Development and Regulatory Unit and its services, contact the Regulatory Affairs Unit Manager, Mary Burke.
The role of the Institutional Trials Unit is to ensure regulatory compliance with federal agencies, all components of the internal UCSF review process (PRC, CHR, and other UCSF Committees), and other collaborating sponsors or foundations.
The Institutional Trials Unit is responsible for all protocol and regulatory support required for activation and maintenance of investigator-initiated trials conducted at the HDFCCC, including:
- Ensure that investigator-initiated protocols contain quality research design, and meet HDFCCC standards
- Develop Protocol & Consent Form from initial concept sheet or Letter of Intent (LOI) to finalized Protocol for CHR Submission/Review
- Amend existing investigator-initiated protocols
- Facilitate CHR Review queries (and Disease Site Committee and PRC queries, as applicable)
- Initial CHR Submission and maintenance studies with the CHR
- Initial IND (FDA) Submission and maintanence of the IND
- Facilitate IND/FDA Review queries
- Initial registration on clinicaltrials.gov, including facilitation of QA Review comments
Below is a timeline for the investigator-initiated protocol development process. The Protocol Project Manager (PPM) begins the process by submitting concepts and protocols to the applicable Disease Site Committee, then submitting the Disease Site Committee-approved protocols to the PRC, and interacting with the CRSO staff to ensure timely completion of study start-up procedures.
The Institutional Trials Unit utilizes prioritization data determined by the different Disease Site Committees to establish the priority order for intiating new investigator-initiated studies. For renewals and modifications of existing investigator-initiated studies, the Institutional Trials Unit determines priority based on the renewal expiration date, patient safety information and study enrollment status.
For more information about the Institutional Trials Unit, contact the Regulatory Affairs Unit Manager, Mary Burke.
Sponsored Trials Unit
The role of the Sponsored Trials Unit role is to ensure regulatory compliance with federal agencies, all components of the internal UCSF review process, and applicable sponsors.
The Sponsored Trials Unit is responsible for all regulatory support required for activation and maintenance of industry-sponsored trials conducted at the HDFCCC, including:
- Develop Consent Forms that meet CHR standards as well as the sponsor requirements
- Submit new and amended protocols to the CHR
- Facilitate CHR Review queries
- Manage External Significant Adverse Events (SAEs) reporting at UCSF clinical site(s)
- Prepare regulatory materials for sponsor monitoring visits, and sponsor or FDA audit visits as applicable
The Sponsored Trials Unit utilizes prioritization data determined by the different Disease Site Committees to establish the priority order for intiating new industry-sponsored studies. For renewals and modifications, the Sponsored Trials Unit determines priority based on the renewal expiration date, patient safety information and study enrollment status.
Cooperative Groups Trials Unit
The role of the Cooperative Groups Trials Unit is to ensure regulatory compliance with federal agencies, applicable national Cooperative Groups (Children’s Oncology Group [COG], Gynecologic Oncology Group [GOG], ALLIANCE, etc.), and with all components of the internal UCSF review process for national Cooperative Group protocols.
The Cooperative Groups Trials Unit is responsible for all regulatory support required for activation and maintenance of Cooperative Group (National Group) trials conducted at the HDFCCC, including:
Prepare new Cooperative Group studies for CHR review and approval:
- Central IRB (CIRB) applications to the CHR where applicable
- Full committee CHR applications where CIRB application is not applicable
- Develop Consent Forms that meet CHR standards as well as the Cooperative Group audit criteria
- Submit new and amended Protocols and Consent Forms to the CHR (all Protocol Amendments/CHR Modification Submissions must meet Cooperative group metrics for approval)
- Assist Investigators with CHR queries
- Manage External SAE reporting and ensure submission to CHR (must meet Cooperative group metrics for review)
- Prepare regulatory materials for Cooperative Group site and/or audit visits as applicable, and assist with preparation of patient charts for audit visits
- Maintain audit-ready regulatory files
The Cooperative Groups Trials Unit utilizes prioritization data determined by the different Disease Site Committees to establish the priority order for initiating new cooperative group studies. For renewals and modifications, the Cooperative Groups Trials Unit determines priority based on the renewal expiration date, patient safety information and study enrollment status.
Publications generated from use of this facility should appropriately acknowledge the UCSF Helen Diller Family Comprehensive Cancer Center Clinical Research Support Office.
A searchable database of core facilities at all UCSF campus locations, provided by the Clinical and Translational Science Institute at UCSF, is available here.
This unit is supported by a National Cancer Institute Cancer Center Support Grant (5P30CA082103). Any publications related to work done by this core should reference grant number 5P30CA082103 and must include a PMCID as required by the NIH. For complete instructions on how to acknowledge funding sources, please see http://grants.nih.gov/grants/acknow.htm. For more information on how to obtain a PMCID, please see http://publicaccess.nih.gov/submit_process.htm.
For more information on the CCSG, please contact Erin Bank, PhD, at email@example.com.