The QSSG has replaced the SOP on FDA Inspection with the Spectrum SOP. Please review the updated document and update your attestation
We’ve updated some guidelines.
-Posted Opening an IIT
-Requesting Tissue from Pathology: Added a distribution list email for pathology
– Completing FDA Form 1572 to provide clarification on sub-investigators.
-We’ve also developed a new guideline on training.
Check them out!
Emailing paper orders to the ITA
Paper orders and consents can now be emailed to ITA at this address: ITAStudyorders@stanfordhealthcare.org .
Since the initial pilot project with the Breast Oncology team which started on 1/4/2021 was a success, the initiative will be rolled out to the rest of the CRGs starting 2/15/2021.
You will find the Emailing instructions in Coordinator Corner in “Guidelines for practice” tab under the subheading “treatment areas”
Change in ORPCS contact info
The Clinical Trials Feasibility for Nursing Services form and the Scheduling a Remote In-Service with Service Centers guidelines have been updated to reflect the change in the contact info over at the Office of Research Patient Care Services (ORPSC).
Study feasibility and In-service requests should now be sent to Roxabeth Frausto (RFrausto@stanfordhealthcare.org), Research associate, and Michelle Williams (micwilliams@stanfordhealthcare.org), executive director.
You will find the feasibility request form in Coordinator Corner in “CRFs/Forms” tab under the subheading “REDCap Forms”, and the Guidelines in the “Guidelines for Practice” tab under the subheading “treatment areas.”
- Dian Le
We have received confirmation that the Medical Records office is accepting faxed patient records. Please see requirements and instructions below.
Medical Record’s fax number is 650-725-9821
CCTO staff may use the already established Cardinal Fax process to send remotely. Any questions or concerns can be emailed to ccto-admin@stanford.edu.
- Dian Le
Since COVID-19, we have been working in a new environment where remote activities became the norm. Nursing in-services at all locations – ambulatory and inpatient setting – are now successfully performed virtually. A new guideline document lists the steps of this process to create a user-friendly resource for all clinical coordinators.
Find the Remote Nursing In-Service Guideline (add hyperlink) at Coordinator Corner in the Guidelines for Practice tab under the subtitle Treatment Areas.
- Dian Le
Feasibility review of clinical trial protocols is a critical step to study intake submission. To add resources to improve this process, the Cancer Clinical Trials Office (CCTO)/Infusion Treatment Area (ITA) taskforce developed a brief nursing feasibility form to support a timely (early) checking of the best/appropriate location (Service Center) to deliver a particular research treatment based on its requirements.
The form, also vested by the Clinical Translational Research Unit (CTRU) and Oncology Inpatient Units at Stanford Hospital, provides a tool of communication between clinical research coordinators (CRCs) and Service Centers (SCs) that confirms their ability to provide nursing service for a new project. This form helps the ongoing efforts to standardize the CCTO existing feasibility process while ensuring that nursing services, may they be planned for the ambulatory or inpatient setting or both, are reviewed prior the creation of the budget and the IRB submission to shorten the study start-up process timeline.
You will find the new tool in Coordinator Corner in the CRFs/Forms tab under the subheading “RedCap Forms”
How to use the form:
1. Follow the instructions to reach out to the appropriate Service Center Liaison(s) with the completed form.
2. Obtain electronic signature to attest early feasibility approval to conduct the trial in their SCs
3. The signed form is then to be uploaded onto the REDCap feasibility form as an attachment to provide evidence of study viability in a particular SC for clinical manger review/approval