Cancer Clinical Trials Office Blog

News & Updates from the CCTO

Updated SOP – Research Participant Records & Data Management in Clinical Trials

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Version 3 of the SOP, Research Participant Records & Data Management in Clinical Trials (formerly known as Data Management in Clinical Investigations), has been updated to address source documents, source data, notes to file and data management in a more comprehensive manner. This SOP is effective 1 August 2021. Please read the SOP and complete the SOP confirmation form to attest to your mastery of the SOP – located on our CCTO website. If you have specific questions, please follow up with Quality at dsmc-quality@stanford.edu or with your manager/group leader. 

Thank you!

REDCAP request for remote monitoring

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Q: When is the good time to submit the REDCAP request for monitoring?

A: A minimum of 14 days ahead of your scheduled monitoring request.

The record processing for remote monitoring involves CCTO-Prism, Privacy Office and HIMS IT teams. Please plan ahead and submit your monitoring request at least 14 days ahead of your scheduled monitor visit. You can always submit your records ahead of time. Your request will be cancelled if there is not enough time to process the record. Once you submit your record you should receive an automated email notification. If you do not receive any email notification please email ccto-prism@stanford.edu immediately.

For updated information and details please visit:

https://med.stanford.edu/ccto/staff-resources/remote-monitoring.html

QSSG Updates

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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!

Updated SOPs in Effect

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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. 

New Protocol Amendment Checklist

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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.