Stanford Cancer Institute Clinical Trials Office Blog

An updated version (Version 2.0) of the SCI-CTO SOP “Assenting Pediatric Research Participants” is effective on 18 December 2023. Version 2 of this SOP will not be available on the website until the effective date. This updated SOP describes the standards for obtaining assent from pediatric participants. Major changes include: -the addition of language regarding usage of e-signatures and Adobe sign to obtain assent, -addition of language regarding usage of RedCap to obtain assent for studies not under the authority of the US FDA. The STARs training module for this updated SOP will enroll learners on 20 November 2023. Due date for this module will be 18 December 2023. Those involved with assenting must complete the STARs training module and review the SPECTRUM SOP before utilizing Adobe sign to obtain consent or assent.

Consenting Research Participants and Legally Authorized Representatives will be effective on 06Nov2023. Technical issues occurred during enrollment and a notification was not sent out by the system to alert you of your enrollment on this course. Please see below for notification of your enrollment.

Please complete this course in STARs before 19Nov2023. Please see enrollment notification email sent on 11/2/2023 for further instructions on access. You can also access this course in STARs under the “All Learning” tab. The course will be listed under “Action Needed” as “Stanford Cancer Institute SOP: Consenting Research Participants and Legally Authorized Representatives”.

The SCI Investigator-initiated trial (IIT) interventional protocol template for has been updated and is available for use here. The goals of the revision were to streamline and simplify the template by providing clear and concise instructions to the authors, eliminating duplicative sections and information, and removing extraneous text.

In addition, addenda have been created for trial types that are used less frequently, by extracting text from the main template for relevant sections. The addenda for multi-site trials and device trials are currently available; an imaging trial addendum is in progress. 

Many thanks to the reviewers, who included investigators, statisticians, quality, and regulatory representatives.

Please use this template for upcoming IITs and provide any feedback to ccto-regulatory@stanford.edu.

When males are enrolled in clinical studies, researchers are often interested in evaluating whether the investigational drugs, devices, or procedures have effects on female partners who become pregnant, and their fetuses. Pregnant partners who are not participants in the research must be consented for this purpose.

Should a partner of a study participant become pregnant, the following must occur prior to collecting data on the pregnant partner:

• A modification must be submitted that includes the Pregnant Partner consent form (the form is only compliant/valid if the form is IRB approved).
• A report must be submitted to inform the IRB of the pregnancy, including a safety plan for that pregnant partner, moving forward.

The GUI-C47 is available at https://researchcompliance.stanford.edu/panels/hs/policies/guidances

Starting on 10 April 2023, the CCTO Orientation Program will include new training requirements and the method for completing SCI SOP training will change. 

CCTO Orientation Program 

Additional trainings are required in the 6-month orientation period for our new CCTO employees starting on or after 10 April 2023:

1) Spectrum Study Teams Roles and Responsibilities and the Delegation of Authority 

2) Spectrum Ethics and Clinical Research 

3) CCTO Cancer 101 

4) SHC Coverage Analysis video – timing based on involvement with budgeting process that includes SHC services (determined by manager)

Continuing employees who have not yet taken the 2 Spectrum classes (#1 and 2 above) are required to take these classes by end of March 2024. Both of these classes are offered in May so those of you who need to take them are encouraged to sign up. 

• May 11 9-10:30AM – Ethics and Clinical Research – register here
• May 23 9-10:30AM – Study Teams Roles and Responsibilities and the Delegation of Authority – registered here

SOP Training 

The platform for SOP training is changing from a self-administered mastery process with attestation on our website, to a STARS program. The SCI SOP Program (CCTO-PROG-1000) includes all SCI SOPs and Spectrum SOPs that SCI has adopted. 

New employees joining on or after 10 April 2023 will be assigned the training program and will have 1 month to complete all of the courses (i.e., SOP trainings [currently 13]) within the program.  

A new CCTO Training & Education webpage has been added that includes links to trainings – this list will continue to grow so check back frequently. Additional training opportunities have also been included on the Investigator Training webpage that may be of interest to you. In addition, the CCTO website is updated to reflect the new orientation program requirements and the new process for SOP training.