- Dian Le
The Regulatory team has created a new workflow process for NCI-CIRB New and Modification Requests. You can find this document on the Regulatory Services page under the SOP/Guidelines tab under the “Other Guidelines” header.
Direct link: NCI CIRB Studies Workflow Process for New and Modification Requests
- Dian Le
This Monday, January 20, is the go-live for CCTO new electronic Study Feasibility Form. CRCs will use REDCap to submit all new studies feasibility evaluation for their managers’ approval. This secure, user-friendly form can be accessed at https://is.gd/feasibility_form. Attached to the Feasibility questionnaire you will find resource tools (users’ manual) that you can access online.
The users’ manuals are available at the CCTO website: Staff Resources > Coordinator’s Corner > Guidelines for Practice > Study Initiation > Feasibility Form User Guides. Managers will be presenting the electronic tool on staff meetings and discussing with CRCs how to use it. The centralized Feasibility evaluation will foster audit for completions and track projects for workforce forecasting.
- Dian Le
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!
- Dian Le
There is a new SOP document available on the CCTO Regulatory page that has replaced 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
All CCTO clinical staff: Please review the SOP and retake the SOP attestation to confirm that you have read it.
- Dian Le
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.