Training and Quality Assurance
The Cancer Clinical Trials Office provides training and quality assurance programs for both new and existing research staff to ensure that Cancer Institute research staff are current on all regulatory requirements as well as SCI standard operating procedures. Programs include:
• Clinical Research Staff Hiring, Orientation and Training
The CCTO will assist with hiring and training of Cancer Institute research nurses, study coordinators and data managers. While the majority of research staff members report to, and are supported by, a Principal Investigator, they are now required to complete Cancer Institute orientation and training as specified by Cancer Institute leadership. Requirements include attendance at orientation meetings, completion of CITI HIPAA and Good Clinical Practice training, review of all Cancer Institute standard operating procedures and attendance at monthly Educational Meetings.
Please inform Miriam Bischoff, Executive Administrative Director, Clinical Research Stanford Cancer Institute, of any research personnel to be hired, terminated or changing roles, so that orientation is planned for new staff and that access to research databases (e.g. OnCore) be updated appropriately. For more on the recommended orientation of new Cancer Institute research staff see New Employee Orientation.
• Quality Assurance Program
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.
• Standard Operating Procedures Development and Maintenance
The Regulatory Manager of the CCTO develops and maintains a set of Standard Operating Procedures, document templates and guidelines. 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.
• 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.
• 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.
• 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.
• Clinical Trials Forum
The Clinical Trials Forum is targeted toward all Cancer Institute investigators and staff. At these meetings investigators present new and ongoing research studies and results of concluding research studies.
• Newsletter
The newsletter, published 10 times per year, includes updates on regulatory procedures, meeting announcements, CCTO services, newly opened trials, and staff updates.
Trial Administration