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IMPORTANT REMINDER: Winter Closure Timelines for Onsite and Remote Monitoring

December 7, 2023 - SCI Communications

** Dec 18th, 19th, and 20th No Onsite visit, Remote monitoring only.** 

** Jan 4th and Jan 5th, 2024, No Onsite visit, Remote monitoring only.**

SCI-CTO will not be hosting onsite and remote visits from Dec 21th 2023, through Jan 3rd, 2024. 

Monitoring for Jan 4th, 2024, and Jan 5th, 2024, PRISM submission timeline is as follows:

All record release requests must be submitted by 11 a.m. Dec 15th, 2023, or the visit will be canceled. 

All monitoring between Jan 6th 2024 through Jan 17th, 2024 – PRISM submission timeline is as follows: 

All record release requests must be submitted by December 18th, 2023, or the visit will be canceled. 

**All New or Renewal PRISM account requests must be submitted 30 days prior to the scheduled Monitoring visit**

Please reference the summary of deadlines in the table below.

2023 Winter Closure PRISM Submission Deadlines 
All New or Renewal PRISM account requests must be submitted 30 days prior to the scheduled Monitoring visit.
Visit DateOnsite MonitoringRemote MonitoringRecord Release 2023 Submission Deadline 
December 7Checkmark with solid fillCheckmark with solid fill11 am November 22
December 8Checkmark with solid fillCheckmark with solid fill11 am November 22
December 18Close with solid fillCheckmark with solid fillDecember 4
December 19Close with solid fillCheckmark with solid fillDecember 5
December 20Close with solid fillCheckmark with solid fillDecember 6
SCI-CTO will not be hosting Onsite or Remote monitoring visits from December 21, 2023, Through January 3, 2024.
January 4Close with solid fillCheckmark with solid fill11 am December 15
January 5Close with solid fillCheckmark with solid fill11 am December 15
January 6, 2024, through January 17, 2024December 18
**If deadlines are not met, the visit will be canceled**
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If you have any questions or concerns, please email ccto-prism@stanford.edu.

PRISM Monitor Attestation Form

November 29, 2023 - SCI Communications

Please be sure you are giving the monitors the 2023 version of the attestation form to complete and sign. We are still getting the 2020 version submitted. As of January 4, 2024, we will no longer be accepting the old 2020 version.

The 2023 version of the Attestation form can be found here.

Please reach out to CTO-PRISM Team at ccto-prism@stanford.edu for questions or concerns. 

2024 Intake Trainings CCTO-1001 & 1002 now on Axess 

November 29, 2023 - SCI Communications

For 2024 the Intake training CCTO-1001 & 1002 sessions are open and available for self-enrollment. 

Search Catalog https://axess.sahr.stanford.edu/group/guest/search-catalog

New Protocols (CCTO-1001)- Course Description: Intake submission process for New Protocol, review of the Intake request form, documentation requirements, REDCap instrument requirement, and SCI-CTO Activation Dashboard.

Amendments(CCTO-1002)-  Course Description: Intake submission process for Amendments, review of the Intake request form, documentation requirements, REDCap instrument requirement, Intake resources, and SCI-CTO Activation Dashboard.

The pre-reqs for both courses are listed below.

  • CCTO-0002 “A Day in the Life of a Clinical Research Coordinator”
  • CCTO-0003 “Study Start Up and Regulatory Documentation” 
  • CCTO-0004 “Cancer: OnCore Basic Training”
  • CCTO-0006 “Study Financial Management”

If you have any questions, please reach out to the CTO-Intake team at ccto-intake@stanford.edu

Welcome!

November 22, 2023 - SCI Communications

 Shruti Murthy 

The SCI-CTO welcomes Shruti Murthy, our new Clinical Research Coordinator Associate with Cancer Cell Therapy. Shruti has a Ph.D. in Biotechnology from Bangalore University, India. Prior to joining SCI-CTO, she worked as a Clinical Research Coordinator Assistant and Clinical Research Scientist at a medical diagnostic startup. Shruti is excited to be here and looking forward to working and learning from the wonderful team. Please help us welcome Shruti! 

New Regulatory Services Resources

November 17, 2023 - SCI Communications

New resources have been added to the Regulatory Services – Investigator-Initiated Trials page on the website. Please refer to these documents for guidance regarding Sponsor-Investigator responsibilities and assessment of IND/IDE determinations during development of Investigator-initiated trials. These include:

  • Sponsor-Investigator IND Training slides
  • Investigator Checklist for IND Exemption
  • Investigator Checklist for IDE Exemption

Please reach out to CTO-Regulatory at ccto-regulatory@stanford.edu for questions or assistance.

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