Cancer Clinical Trials Office Blog

The Quality Standards on Standard Operating Procedures and Guidelines Committee (QSSG) is seeking your opinions on an updated SOP entitled “Consenting Non-English Speaking Subjects”

The committee is seeking feedback regarding:

1) readability

2) feasibility (please explain why or why not)

3) key elements/steps believed to be missing

Please don’t provide corrections on grammar, spelling, and formatting, as this will be reviewed prior to release.

Feedback will be accepted until 22-Nov-2019 at the following link: https://stanforduniversity.qualtrics.com/jfe/form/SV_dp90i3mehcjyyCV. Please note that the proposed SOP language is embedded in the Qualtrics survey. A small token will be given to those who complete the survey.

Thank you!

There is a new SOP document available on the CCTO Regulatory page that will replace both the Obtaining Informed Consent and Reconsenting Clinical Trial Subjects SOPs:

Informed Consent for Adult, English‐speaking Participants (Initial and Re‐Consent (PDF) – Jun 18, 2019

This SOP is currently pending and will go into effect on June 18.

Version control continues to be a hot topic.  To help address this, two new guidance documents have been prepared and are now available on the CCTO Regulatory Services page regarding version control.  The first provides the version control recommendation for investigator-initiated trials (IIS/IIT), and the second is general guidance for other CCTO documents.  

Please use these guidelines when creating and updating your documents.

• Version Control Process for Investigator initiated Study Protocols (IISs / IITs)
• General Version Control Process for CCTO Documents

As we enter the new fiscal year (FY19) please note the University’s updated Financial Irregularities Policy.

The update includes:

• additional examples of what constitutes a Financial Irregularity
• who to contact if you have related concerns,
• and the standard processes that should be followed at the University.

For additional information, please review the accompanying Frequently Asked Questions.