SU HRPP Guidance GUI-C47 – Pregnant Partner Consent Process

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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

Welcome to the SCI-CCTO

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Riko Lee

The SCI-CCTO welcomes Riko Lee, our new CRCA with Pediatrics. Riko graduated from the University of Hawai’i with a BA in Biology and a MPH. Prior to joining the CCTO, she was a CRC at the University of Hawai’i Cancer Center as well as, a Graduate Research Assistant for the Hawai’i Health Data Warehouse.

Riko also volunteered at Queen’s Medical Center to help recruit participants for reproductive health related studies, and as a recreational therapy volunteer at a children’s hospital in Honolulu. She is looking forward to meeting everyone in the CCTO and helping her team create a positive impact on patients’ wellbeing. Riko is also excited to start exploring the bay area! Please help us welcome Riko!

Jasmine Newman

The SCI-CCTO welcomes Jasmine Newman, our new Project Manager with Oncore. Jasmine graduated from Coppin State University with a BS in Sociology. Prior to joining the CCTO, she was a Research Project Manager. Jasmine is looking forward to learning more about Stanford’s culture as well as building on her project management skills with her new team. She has two daughters, ages 6 and 11. Please help us welcome Jasmine!

Spectrum publishes memo that addresses study-specific clinical laboratory reference range lists

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In November 2022, Stanford Medicine Clinical Laboratory announced that study-specific laboratory reference ranges would not be provided. To support and elaborate on the information in the November memo, Spectrum published MEM-011 Clinical Laboratory Reference Ranges. This memo may be provided to study sponsors, as needed, to explain that study-specific clinical laboratory normal range lists are not provided. SU approval is not required to share this memo outside Stanford. It is a good practice to make study sponsors aware of this information in the study start-up stage. 

Welcome to the SCI-CCTO!

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Welcome to Aja Macias to the new CCTO Clinical Research Trainer role!

This new role was created to help enhance and drive the educational trainings and initiatives at the CCTO. Aja’s work will initially be focused on onboarding training of new staff as well as enhancing the educational training(s) and resources available for all CCTO staff.

Aja will maintain a hybrid schedule to facilitate interaction, learning and collaboration with CCTO staff.

Aja comes to this role from the CCTO Early Drug Development research team where she was a CRC2 for almost 3 years. Aja was not only managing multiple Phase 1 clinical cancer trials but she was involved in training and onboarding new staff. She has a very interesting background in teaching as well.

We are very excited to have this new role at the CCTO and for Aja to be our inaugural trainer!  

STARR Users Group Meeting 

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Research Technology is super excited to invite you to the 3rd virtual STARR Users Group Meeting scheduled for May 10-11, 2023. The two half days will feature success stories from the users of STARR, both faculty as well as students as well as Stanford’s increasing participation in various National consortia including OHDSI and PEDSnet. Detailed agenda coming soon.

Do you use STARR data for your research?  We are still accepting submissions for lightning talks and would love to hear about your research. We invite you to sign up by April 15th, 2023.

In addition, we are offering the following four workshops leading up to the meeting:

Zoom and registration Information available here. Detailed agenda coming soon.

Here are links to the past STARR Summit content for your reference: