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!
- Dian Le
There are updated SOPs available on the CCTO Regulatory page:
Identifying and Reporting Adverse Events – Mar 31, 2019
Investigational Product Accountability – Mar 31, 2019
Investigator Responsibilities and Delegation of Authority – March 31, 2019
Remote Consenting of Research Participants – November 18, 2020
All CCTO clinical staff: Please review updated SOPs and retake the SOP attestation to confirm that you have read it.
- Dian Le
We can all agree that protocol amendments create a great deal of work for coordinators and a single amendment can take a long time to implement. We are happy to introduce you to a checklist tool that can be utilized to keep track of all necessary actions when a sponsor sends documents for a protocol amendment.
It is located under Coordinator Corner > Tools/Templates > Protocol Amendment Checklist
Few notes on how this checklist can be helpful:
1. Most protocol amendments will take somewhere between 1-4 months to implement, from the moment we submit to ccto-intake for processing to IRB approval and/or contract execution. This checklist is designed to help you plan ahead and serve as a reminder of what needs to be done (e.g., when you get the IRB approval after 2 months of initial submission or when you get the amended contract executed after 4 months, by referring to this checklist, you can quickly identify pending action items).
2. It will help with self-monitoring of study requirements (e.g., who still needs to be trained?).
3. This checklist can be used as a guide when discussing protocol amendments with your PI or your manager, depending on how your CRG functions. It is totally optional to use the “Review and Signoff” section but remember to remove the section if you do not plan on implementing this process (otherwise the checklist will appear incomplete!).
4. When you take over studies from other coordinators or need to refer back to previous protocol amendments, if this checklist was completed, you may be able to find your answers quickly! (e.g., Why was subject 001 not re-consented?)
5. This checklist was created to serve as a template but is not a requirement. Feel free to modify to meet your study-specific or group-specific needs!
If you have any questions or suggestions, please reach out to jeelee@stanford.edu and elizabethjacobs@stanford.edu.
- Dian Le
All CCTO clinical staff:
There is a new Guideline on how to request imaging from the SHC Film Library. Please review the guideline and check-out the new SU-13-Electronic form under Forms in the Coordinator Corner for imaging your requests. Thank you!
If you have questions regarding the new guideline, please contact your manager.
- Dian Le
For ease and accuracy of serious adverse event (SAE) reporting for investigator-initiated trials (IITs), CTTO-Regulatory is introducing additional IIT SAE report forms. These forms are variants of the current form, but allow attribution to multiple agents within a single form. The two new PDFs forms below are available on the Coordinator Corner under the Forms tab in addition to the initial form of one agent: