The monitoring webpage has been updated!

-

We are excited to announce some updates and improvements to the CCTO Monitoring webpage! Here are some updates you can expect:

1. Onsite Monitoring Guidelines: We have included on-site monitoring resources and have updated many of the SOP.

2. Revised SOPs, Guidelines, and User manuals: We have updated all of the outdated documents.

3. Checklist for Record Release: We have updated it to include requirements that were missing as well as the record release limit to 16.

4. Revised Monitor application: We have revised the outdated monitor application form. Please use this newly revised application form when submitting for a new PRISM account as well as all renewals.

We encourage all staff to please visit (add a link to the Monitoring webpage) to explore the new updates! Please contact ccto-prism@stanford.edu with any suggestions, questions, or concerns.

Are you involved with writing or updating IIT protocols? An updated guideline for document version control is released.

-

An updated version of the CCTO Guideline “Version Control Process for Investigator-initiated Study Protocols” is now posted on the CCTO website under Regulatory Services at https://med.stanford.edu/ccto/services/regulatory.html#investigator-initiated. Key highlights of this guideline are listed here. Please review the guideline for details. 

  • Maintain a complete and up to date history of versions of the document in the protocol history table. Include a brief, bulleted list of changes for each version after the first version. 
  • Label protocols with a version number and date on the title page and footer of each section of the protocol. 
  • For protocol amendments, always pull the current IRB approved protocol from eProtocol as the starting point for the amendment. Another copy (e.g., from your desktop, Box) may not be the most current version. 

Please contact CCTO-Regulatory@stanford.edu with any questions related to this process.

IIT Services Coverage Plan

-

In the past ten years, Neal has provided in-depth IIT services to researchers and study teams supported by SCI-CCTO, including submitting IND/IDE initial application packages on behalf of PI, assisting with annual IND reports, managing IRB records for IITs, preparing and submitting ClinicalTrial.gov result reporting and offering protocol consultation. Unfortunately, Neal retired on February 3, 2023.  

We have started recruiting for his position, and replacing such an expert takes work. While focusing on finding a suitable replacement for IND services, we developed a coverage plan relying on internal resources. Madhulika Dayal, SCI-CCTO Regulatory Manager, and I developed an interim coverage plan until we hire a new person for Neal’s work responsibilities. Sweta Tamboli, Regulatory Specialist 2, will support your current and future IND submissions, including new INDs, IND annual reports, and any amendment to existing INDs. Madhulika Dayal, her manager, will be supporting her and providing backup. Swetha Dintakurthi, Regulatory Specialist 2, and I will assist with CliicalTrials.gov result reporting. Yoriko Imae, Regulatory Specialist 2, will support Single Patient IND projects. We have met with Neal regularly in the past few weeks to transition current projects. 

In the upcoming weeks, we will contact PIs to provide status updates on their IND and IIT.

Summary of coverage plan

TaskInterim Coverage
IND application initial submission to FDA, IND
annual report, amendments to existing INDs,
and closing INDs		Shweta Tamboli / Madhulika Dayal as back up
IIT study submission to IRBShweta Tamboli / Madhulika Dayal as back up
Single Patient INDYoriko Imae / Shweta Tamboli as back up
Ct.gov result reportingAgnes Nika / Swetha Dintakurthi
IIT protocol consultationTBD; no current available expertise 
Safety ReportingSoulaima Houcheime / Yoriko Imae 

Please contact Madhulika and Agnes Nika with any questions and/or concerns.

Updated SOP “Consenting Research Participants and Legally Authorized Representatives” Version 2 Effective 24 October 2022

-

The SCI SOP “Consenting Research Participants and Legally Authorized Representatives” Version 2 will be effective on 24 October 2022.

The SOP was updated to remove the NCI CIRB requirement for a witness in all cases of remote consent as CIRB has eliminated that requirement. No other substantive changes were made. This updated SOP will be reviewed at the 20 October 2022 CCTO All Staff meeting. 

Questions regarding this new SOP should be directed to DSMC-Quality@stanford.edu 

Update of SOP Investigator-Initiated Multi-Site Trial Management, Effective 12 September 2022

-

The SOP, Investigator-Initiated Multi-Site Trial Management, has been updated (version 5, effective 12 September 2022). The key change includes:

  • Inclusion of procedures required when changing from a previously approved single site trial to a Stanford-led multi-site trial (Section 5.4).

If this is applicable to your work, please review this updated SOP as soon as possible at https://med.stanford.edu/ccto/services/regulatory.html#sops and attest to your mastery of the information in the SOP confirmation form available on the same webpage.