Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

Training and Quality Assurance

The Cancer Clinical Trials Office (CCTO) 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

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.

For all new hire requests contact Brenda Hann, RN, Director of Clinical Research Operations at 650-723-0966.

• 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, maintain 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 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 Clinical Research Quality program is focused on quality improvement of Investigator-Initiated Trials (IIT). When a new IIT is opened to accrual, the Quality Coordinators perform a quality review of the protocol, consent, and eligibility checklist and ensure the trial's clinical research staff understands expectations of quality research and standard operating procedures. The Quality Coordinators perform a quality check of eligibility for the first three patients enrolled on a new IIT. If an IIT is multi-site, the Quality Coordinators also review the first patient enrolled from each study site. The Quality Coordinators also assist with internal monitoring as the study progresses.

To request a review of eligibility or for any quality related questions, please email the Quality Coordinators at ccto-quality@stanford.edu

• 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.

• 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.

 

Stanford Medicine Resources:

Footer Links: