Cancer Clinical Trials Office Blog

CCTO: COVID Flex hours are available for use, retroactively beginning January 1, 2021 through September 30, 2021. For eligibility and additional information please refer to the University website at: https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-flex-hoursIf

If timecards need to be adjusted, please send a ticket to AskMySCI-HR and open a ticket. Detail the day to be adjusted and the HR team will make the adjustments on your behalf. Any accrued / paid time will then be credited back for future use. Please let your HR team know if there are additional questions.

There are a variety of positions open at the CCTO, see the chart below or visit Stanford Careers (search Cancer Clinical Trials Office). If you want to refer a friend, reach out to the CCTO HR Team at askmysci-hr@stanford.edu. 

Referral

SCI is offering a referral bonus of up to $1000 if your candidate is hired into an open position in SCI/CCTO. If you and the candidate fit the eligibility criteria, ask them to apply online and list your name under source tracking: employee referral. Please fill out the referral form and send it along with the candidate’s resume to the CCTO HR Team. More requirements and details are available on the referral form. If you have any questions about the referral program please contact CCTO HR Team.

Position	CCTO Group Name	Requisition #
CRC2	Breast	88705
CRC2	Breast	88988
AA2 (1yr fixed)	CCTO	88532
AA2	CCTO	88754
RA2	CCTO	88986
CRCA	GU	89055
CRC2	GU	89088
CRCA	GI	88780
CRC2	Gyn	87483
CRCA	Gyn	88810
CRCA	H&N	89049
CRCA	H&N	89299
CRC2	H&N	89056
CRC2	Hematology	87202
CRC2	Hematology	89024
CRC2	Hematology	87416
Process Manager	OnCore	88755
CRCA	Pediatrics	88220
RN2	Pediatrics	88987
CRQM	QA	88005
CRCA	Radiology	89163
CRCA	ThorOnc	88009

Version 8 of the Investigator-initiated Protocol Template is available at the CCTO Regulatory / Investigator-initiated webpage.  The template has been extensively updated to help produce robust and clearly-written clinical research protocols, and follows the requirements of 21CFR§312 & ICH E6(R1-2).  The new template is aligned to the NIH phase 2-3 protocol template, with considerations for studies that are primarily dose-finding and/or dose-escalation, and is also aligned to the recent CCTO Data and Safety Monitoring Plan (DSMP).  The prior single-center and multi-center templates are merged into one document.  Redundancies and contradictions have been eliminated or reduced throughout.  SAE reporting and the elements for ClinicalTrials.gov are extensively updated.  Template information is also provided for device studies per 21CFR§812.  Lastly, formatting in the template has been cleaned up throughout the document.

Please be aware that the “SRC Pre-review” will begin checking for use of the new template as of 30 June 2021.  Please plan accordingly, and download the new template from the website.  Do not use your locally-saved copy of the prior template for new studies.

For questions, please contact CCTO-Regulatory@Stanford.edu.

This post brings clarity to the concept of research-related procedures in regards to the scientific protocol document, eProtocol application, and consents.  Research-related procedures should be handled in a consistent manner, regardless of whether or not it is a radiation procedure or a non-radiation procedure.  The key understanding of research-related procedures is very basic, ie, any procedure that a study participant would not normally undergo if not participating in a research study.  This means that a procedure that could normally be conducted would be handled as normal or regular medical care in eProtocol and the consent, and that a procedure that would not normally be conducted, or is conducted at excess frequency, will be handled as research-related procedures (RRP).  RRP required adequate disclosure in the eProtocol application and consent document, including a complete and accurate discussion of the risks of the research-related procedures.

When CCTO-Regulatory is requested to assist with an eProtocol application, modification, or consent, we may ask the Protocol Director / Principal Investigator to confirm or identify which procedures are research-related.

Please also note that these definitions do not use nor include the term “Standard of Care / SOC.”  SOC refers to a procedure that is conducted according to the standards of Stanford Medicine, and neither includes nor excludes that a research subject would normally undergo the procedure.  It is common for research studies to include research-related procedures that are to be conducted according to the standards of Stanford Medicine (ie, SOC), but the procedures either would not be conducted except for the study, or will be conducted at excess frequency.  The fact that these procedures are conducted according to “SOC” does make them regular care, ie, not research procedures.  All procedures that are not part of regular care, or more frequent than standard care, are research-related procedures.  The determination of whether a procedure would normally be conducted, or is conducted at normal frequency, is the doctor’s medical decision, per ICH E6(R1-2) GCP.  Depending on the study, the doctor may make this decision independently, or may concur with the proposal of others, such as an industry sponsor or the Ankura coverage determination.

For questions, please contact CCTO-Regulatory@Stanford.edu.