SCI Cancer Clinical Trials Office Blog

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.

A new SCI SOP “Assenting Pediatric Research Participants” will be effective on 24 October 2022. 

This new SOP describes the procedure for assenting children (generally 7-17 years old) to research. Please note the parental consent/legally authorized representative (LAR) process is described in the SCI SOP “Consenting Research Participants and Legally Authorized Representatives.” 

Please attend the CCTO All Staff meeting on 20 October 2022 when training will be provided. In addition, training will be provided within CRGs that work with pediatric research participants. 

If this SOP is applicable to your work, please review this SOP prior to the effective date of 24 October 2022 at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available on the same webpage.

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