Regulatory Updates — SCI Cancer Clinical Trials Office Blog

IIT Services Coverage Plan

February 6, 2023 - SCI Communications

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

Task	Interim 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 IRB	Shweta Tamboli / Madhulika Dayal as back up
Single Patient IND	Yoriko Imae / Shweta Tamboli as back up
Ct.gov result reporting	Agnes Nika / Swetha Dintakurthi
IIT protocol consultation	TBD; no current available expertise
Safety Reporting	Soulaima 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

October 20, 2022 - SCI Communications

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

September 7, 2022 - SCI Communications

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.

OnCore entry of Serious Adverse Events (SAEs)

September 23, 2021 - SCI Communications

Since November 2019, CCTO-Safety does not process any Serious Adverse Events (SAEs) for Industry sponsored trials into OnCore. Do not send SAE reports to CCTO-Safety for Industry sponsored trials.

CCTO-Safety will only process SAEs reports for Investigator-Initiated Trials into OnCore.

The Regulatory SOP and guideline documents have been updated. Also, the SAE CRFs (3 forms) are updated and uploaded. https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html#regulatory

Update on IIT Protocol Template and REDCap Intake

July 12, 2021 - SCI Communications

Adoption of the new protocol template is going well since it’s availability 30 April. However, we are aware that some IIT studies are still being received or developed on the old template, despite the upcoming deadline of 30 June for acceptance of all new IIT protocol on the old template. The deadline is extended until 30 July, which is 3 months from the announcement and availability of the new template. Until 30 July, new IIT protocols submitted on the old template will continue to be referred for a Regulatory consult to insert key aspects of the new template, specifically, alignment to the current SCI Data Safety Monitoring Plan (DSMP) and ClinicalTrials.gov considerations. After 30 July, submitters will be asked to re-submit on the new template, which will include this information by default.