SCI Cancer Clinical Trials Office Blog

News & Updates from the SCI-CCTO

Updated and New Guidelines posted on CCTO Coordinator Corner

-

The following guidelines are posted on CCTO Coordinator Corner. Please review these guidelines for awareness and as they are applicable to your work. Questions about any of these processes may be directed to DSMC-Quality@stanford.edu.

Opening an Industry-Sponsored Trial

This updated guideline is a tool to guide the process for activating an industry-sponsored trial. Version 9 is updated to include current information for this process. This guideline may be found in Coordinator Corner under the Start-up/Close-out tab in the Overview section.

Participant Payments

This new guideline is a tool to guide the process for setting up systems for and managing participant payments for both reimbursements and stipends. This guideline may be found in Coordinator Corner under the On-Study tab in the Finance section. 

Transitioning Coordinators 

This updated guideline is a tool to guide the process for transitioning the management of a study from one coordinator to another. Version 5 is updated to include the current information for this process. This guideline may be found in Coordinator Corner under the Regulatory tab in the Regulatory Documentation section.

New SOP “Corrective and Preventive Action Plan” Effective 1 February 2023

-

A new SCI SOP “Corrective and Preventive Action Plan” is effective on 1 February 2023. 

This new SOP describes the process for developing, managing and evaluating a corrective and preventive action (CAPA) plan. Please refer to this SOP any time you are involved in the CAPA process. 

If this SOP is applicable to your current work, please review this SOP prior to the effective date of 1 February 2023 at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available at the bottom of the same webpage.  

An updated version of the SCI CAPA template is available on CCTO Coordinator Corner. Please use this document moving forward for all CAPAs unless another form is required by an external party. 

Questions regarding this new SOP should be directed to DSMC-Quality@stanford.edu  

Laboratory Reference Ranges 

-

SHC/LPCH Clinical Lab leadership communicated that laboratory reference ranges would no longer be provided in lists of normal ranges. It is important to communicate this with sponsors of new studies in the start-up stage so there are no surprises. It may also be necessary to communicate with sponsors of ongoing studies that expect these lists to be provided. The memo may be shared with sponsors upon request. 

See the memo from Dr. Kong dated 10 November 2022 on Coordinator Corner in the Study Start up/Close Out tab, Clinical Lab section at https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html

Please note that current SHC/LPCH laboratory licensure and other lab-related documentation are available at https://stanfordlab.com/test-directory/licensure.html. OnCore also has a repository of current and historic licensure and lab director CVs. To navigate to these documents in OnCore, select PC Console and type “lab-docs” into the “select protocol” field. 

Welcome!

-

Thu Nguyen

The CCTO welcomes Thu Nguyen, our new CRC2 with Hematology. Thu graduated from the University of California, Davis with a BS in Biological Science. Prior to joining the CCTO, she was a research coordinator at SI-Bone. Thu is looking forward to this new adventure, as well as being part of a new team to start up multiple studies. Please help us welcome Thu!

Alexandria Lim

The CCTO welcomes Alexandria Lim, our new CRCA with Pediatrics. Alex recently graduated from Case Western Reserve University in Cleveland, Ohio with a BA in Biology and Chemistry and a minor in Childhood Studies. During her undergraduate career, Alex worked as a medical scribe in the Emergency Department, a research student in the PICU, and a teacher at a childcare facility. In her free time, she enjoys working out, baking, watching soccer, and trying new things! Alex is looking forward to further pursuing her passion for the field of Pediatrics, expanding her knowledge of cancer clinical trials, and getting to know her CCTO team. Please help us welcome Alex!

Melissa Hance

The CCTO welcomes Melissa Hance, our new Financial Specialist. Melissa has a BS from Illinois Weslayan University and an MS from the University of Georgia. Prior to joining the CCTO, she was a Research Advancement Administrator Sr. at Arizona State University. Melissa is looking forward to supporting the Cancer Center with Clinical Trials as well as  working with the great team in the CCTO Finance Office.  She is grateful for this opportunity and very happy to be working at Stanford. Please help us welcome Melissa!

Ananya Ray

The CCTO welcomes Ananya Ray, our new CRCA with BMT. Ananya graduated with a Bachelor’s degree in Dental Surgery from Guru Nanak Institute Of Dental Surgery & Research, India. She also holds an MBA in Hospital and Healthcare Management from Indian Institute of Social Welfare and Business Management, India along with a certificate in Clinical Research Conduct and Management from UC Berkeley. Prior to joining the CCTO, Ananya practiced clinical dentistry for more than 6 years in India. She also worked as a Clinical Research Assistant at Edifice Health, a biotech startup. She is excited to have the opportunity to be associated with the clinical research team at the Stanford Cancer Institute, one of the best global research centers in the realm of Cancer Cell Therapy. The cutting-edge research here resulted in the development of the novel CAR T- Cell therapy. Ananya is looking forward to being part of the research team and will take this opportunity to learn, grow and contribute to the great endeavor of the clinical research program. Please help us welcome Ananya!

Vincent Vu

The CCTO welcomes Vincent Vu, our new CRC2 with Pediatrics. Vincent graduated from Arizona State University with a BS in Medical Studies. Prior to joining the CCTO, Vincent worked at Phoenix Children’s Hospital as a Clinical Research Coordinator. He is looking forward to being part of a large cohesive team that strives to innovate. Vincent also loves how rich the history is here at Stanford. He is fairly familiar with most COG studies so if you have any questions regardless of disease group, he can help! Please help us welcome Vincent!