Cancer Clinical Trials Office
The Cancer Clinical Trials Office (CCTO) provides regulatory, administrative, research, training and educational services to SCI investigators and staff conducting clinical trials. Programs of the resource serve to increase awareness and accrual to clinical trials as well as to improve the quality and efficiencies of conducting clinical trials in compliance with regulatory, documentation, and oversight requirements.
Facilitate clinical trials and translational research by providing centralized regulatory, financial, and administrative support to all SCI investigators.
- Protocol development consultation
- Regulatory document preparation and maintenance
- Study initiation, auditing and monitoring assistance
- Centralized safety and protocol violation reporting
Provide research support services.
- Hiring, training, and supervision of clinical research staff
- Provide coverage for study coordination during research staff leaves of absence
Centralize and standardize data collection and reporting of clinical research.
- OnCore Database
- Report generation
- Electronic Case Report Forms for Investigator-initiated trials
Provide programs to contribute to quality assurance of performance and the ongoing education of SCI clinical research personnel.
- Clinical research staff hiring, orientation and training
- Standard operating procedures development and maintenance
- Monthly educational programs for research staff
- Mandatory training prior to commencing each Investigator-sponsored trial
- Annual Clinical Research Forum for research staff and community affiliates
Coordinate outreach efforts in the community to increase clinical trials awareness and accrual.
- Protocol listings, mobile search app, Cancer Center kiosks
- Clinical trials phone line
- Clinical Trial Patient Advisory Committee
- Educational events and collaboration with community organizations
- Outreach program
- Administration of an ECOG affiliates program
Promote interdisciplinary collaborations and translational medical research.
- Translational research facilitation
- Communications and collaboration
Clinical research staff hiring
The CCTO hires, trains, and supervises all new cancer-focused clinical research staff. Clinical research staff based in departments and divisions and hired before July 1, 2013, will be supervised jointly by a CCTO Supervisor and their Departmental Supervisor. For further information read: Cancer Clinical Research Supervision and Oversight FAQ's.
Orientation and training
All clinical research personnel are required to complete a 7-session Cancer Clinical Research Orientation Program along with completion of CITI GCP on-line training, and review of SCI Standard Operating Procedures.
Mandatory training prior to commencing each investigator-sponsored trial
In 2007, the CCTO entered into an agreement with the IRB and School of Medicine to provide to provide IRB mandatory training to Cancer Institute investigators who plan to conduct a sponsor-investigator clinical trial using an investigational drug. The IRB alerts the CCTO Regulatory Manager of the new trial, and the CCTO Regulatory Manager conducts the training prior to IRB approval of the study.
Standard operating procedures and guidelines
The Regulatory Manager of the CCTO maintains a set of Standard Operating Procedures (SOP's), document templates. These documents are developed in order to establish a level of quality and standardization in the operations of our research staff. The CCTO will confirm that each research staff member has reviewed the SOPs. The Director of Clinical Research Operations, in collaboration with the Regulatory Manager, maintains a set of Guidelines for Practice. These guidelines were developed by clinical research coordinators and are designed to complement the SOPs. The Guidelines reflect best practice and provide comprehensive steps for study initiation, conduct, and closure.
Quality assurance program
The Quality Assurance Program is designed to provide collegial and constructive monitoring and training as part of SCI’s Clinical Research Oversight Group (CROG). Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, local guidelines for practice, and the applicable regulatory requirement(s). The Quality Assurance Team conducts monitoring of investigator-initiated trials (IIT) and cooperative group trials. The quality assurance program of the CCTO is implemented in conjunction with the Data and Safety Monitoring Committee (DSMC)’s auditing function. Auditing includes a comprehensive review of all regulatory documentation, and for a randomly selected set of subjects, confirmation of the eligibility of participants, verification of data validity and integrity and protocol compliance. All Cancer Institute research staff are to participate in two audits per year as an educational activity.
For trials using OnCore for study data collection, the CCTO staff works closely with study staff to ensure accurate data abstraction, transcription, submittal of case report forms and entry into the OnCore database.
Clinical research quality program
The Quality Assurance team is responsible to ensure that investigator-initiated trials (IIT) and cooperative group trials are reviewed regularly for participant eligibility, regulatory compliance, and safety issues; that adverse reactions are reported in compliance with local and government regulations, and as appropriate are reviewed by the Data and Safety Monitoring Committee; that data collected on these trials is accurate, reliable, verifiable, and reproducible. This contributes to ensuring that SCI trials remain in compliance with all institutional and federal regulations.
When a new cooperative group or IIT study is opened to accrual, a Clinical Research Quality Assurance Specialist/Internal Monitor from the Quality Assurance team will perform a quality review of the protocol, consent, and eligibility checklist and ensure the trial's clinical research staff understands expectations of quality research conduct and SCI’s standard operating procedures. The Clinical Research Quality Assurance Specialist/Internal Monitors perform a quality check of eligibility for the first three patients enrolled on a new IIT and the first patient enrolled on a cooperative group trial. If an IIT is multi-site, they also review the first patient enrolled from each study site. The Clinical Research Quality Assurance Specialist/Internal Monitors also assist with internal monitoring as the study progresses, and quality checks across all studies to ensure SCI guidelines are being followed.
Monthly educational programs for research staff
The CCTO presents monthly educational meetings for all research nurses, study coordinators and data managers. These meetings bring together research staff from all areas of the Cancer Center to discuss relevant educational and operational issues. Most meetings are recorded and made available on our internal web site for staff unable to attend the meeting.
Annual clinical research forum for research staff and community affiliates
Since November 2005, the CCTO has presented an annual all-day educational program for all Cancer Institute research staff and research staff at our community affiliates.