SCI-CTO Guideline Update: Opening a Single-center Investigator-Initiated Trial (IIT) 

-

The SCI-CTO guideline “Opening a Single-center Investigator-initiated Trial” version 9 is released and available on Coordinator Corner (Study Start-up/Close Out tab, Overview section). The document, which describes the activities required in the development and activation of a single-center Stanford IIT, has undergone extensive changes from the prior version. 

Scope: Single-center Stanford IITs

Training: 

  • Staff directly involved in opening and managing IITs should review the document thoroughly in order to apply the information to your work.
  • Staff not directly involved in opening and managing IITs should review the document for awareness.

Please direct questions to DSMC-Quality@stanford.edu.

Q & A with QA

-

“Q & A with QA”Welcome to our first posting of “Q & A with QA” created by the Quality Assurance team. We believe all questions are important and if one individual has a question about something, then it’s likely others may have as well, or will at some point. We hope these blog posts will provide insight into common questions asked by study teams so that everyone can be included in the conversations. Of note, the questions we post are paraphrased and not taken directly from any one individual.

Question:

What is the best way to document that the treating investigator has reviewed and assessed safety labs (as clinically significant (CS) or not clinically significant (NCS))?  We currently print the lab results for signing/dating by the treating investigator to document their assessment, but we would like to move away from paper.  What are our options?

Answer:

Printing the lab results and having the investigator document their assessment if CS or not is certainly one reliable method.  

  • An alternative method to document the review of safety labs by the treating provider is via the electronic medical record. The lab results can be pulled into the progress note for the applicable study visit, in which the treating investigator  can document that the labs were reviewed. If any out of range labs are present, the provider should indicate whether they are CS or NCS.  This allows real-time documentation as the e-signature verifies when the documentation occurred (meets ALCOA*).

For example, some teams have created a specific smart-phrase and utilized this in documentation encounters to indicate how they are documenting lab result assessment. The labs that need to be assessed are incorporated in the progress note, and the investigator bolds/highlights the specific labs that are assessed as clinically significant.  The smart-phrase will indicate “Clinically significant labs are bolded in red/highlighted”. 

Please discuss among your team to find a feasible work flow.

* Elements of Good Documentation Practice (GDP)= ALCOA

Attributable, Legible, Contemporaneous, Original, and Accurate.

Want to keep the conversation going?

Please join us at our Wednesday 9:00-9:30 QA Virtual Chat Join from PC, Mac, Linux, iOS or Android: https://stanford.zoom.us/j/93986583586?pwd=WmsrOUc2VklFbGN4amp5amxGUDZwUT09

Password: 153280

Or please feel free to send your questions to: dsmc-quality@stanford.edu

The monitoring webpage has been updated!

-

We are excited to announce some updates and improvements to the CCTO Monitoring webpage! Here are some updates you can expect:

  1. Onsite Monitoring Guidelines: We have included on-site monitoring resources and have updated many of the SOP. 
  2. Revised SOPs, Guidelines, and User manuals: We have updated all of the outdated documents. 
  3. Checklist for Record Release: We have updated it to include requirements that were missing as well as the record release limit to 16. 
  4. Revised Monitor application: We have revised the outdated monitor application form. Please use this newly revised application form when submitting for a new PRISM account as well as all renewals.

We encourage all staff to please visit (add a link to the Monitoring webpage) to explore the new updates!

Please contact ccto-prism@stanford.edu with any suggestions, questions, or concerns. 

Welcome to the SCI-CCTO!

-

Aliha Mughal

The SCI-CCTO welcomes Aliha Mughal, our new CRCA with Blood & Marrow Transplant. Aliha graduated from Princeton in 2023 with a degree in Anthropology and minors in Global Health/Health Policy and Theater. She is looking forward to working with such an expansive team and network that cares deeply about the work they do. Please help us welcome Aliha!

Vivian Leung

The SCI-CCTO welcomes Vivian Leung, our new CRCA with Cancer Cell Therapy. Vivian graduated from UC Davis with a BS in Neurobiology, Physiology and Behavior. Prior to joining the SCI-CCTO she was a Medical Assistant and Workers Compensation Coordinator for an Orthopedic Surgeon and a Clinical Scribe for an outpatient Internal Medicine Physician. Vivian is looking forward to assisting in life-changing medical research. In her spare time, she likes going to the gym, hanging out with friends and reading. Book recommendations are welcome! Please help us welcome Vivian!

Ashleigh Roberson

The SCI-CCTO welcomes Ashleigh Roberson, our new CRCA with Breast Oncology. Ashleigh graduated from The University of North Carolina at Chapel Hill with a BA in Biology. Prior to joining the SCI-CCTO, Ashleigh was a Clinical Research Assistant at UNC School of Medicine in the Pediatrics Food Allergy Immunology & Rheumatology department. She is looking forward to the culture at Stanford as well as, the opportunity to continue growing her skills. Outside of work, Ashleigh enjoys playing with Blade, her 3-month-old puppy. Please help us welcome Ashleigh

Kriti Lalwani

The SCI-CCTO welcomes Kriti Lalwani, our new CRCA with Head and Neck. Kriti graduated from Johns Hopkins University with a BS in Neuroscience. Prior to joining the SCI-CCTO, she was a research technologist in neuro-oncology, also at Johns Hopkins. Kriti is very excited to learn more about clinical research and work directly with patients. She is also looking forward to meeting other members of the SCI-CCTO. Kriti enjoys reading and would love new book recommendations. Please help us welcome Kriti!

Updated PRISM Monitor application is now available!

-

The revised monitor application for PRISM access is now available and we encourage all study teams to use this newly updated form going forward. 

The new form can be found in two locations: 

  1. Within the REDCap CCTO Monitor request form here
  2. On the CCTO Monitoring web page here

Please use this 2023 version when submitting a request for a new monitor’s PRISM account as well as for renewals. 

Please contact ccto-prism@stanford.edu with any questions.