SRC Reminder – New Version of the Protocol Statement of Support

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The initial Protocol Statement of Support (PSOS) has been updated (version 4- dated 8 Dec 2021). 

And is now available on the Scientific Review Committee (SRC) website to download. 

https://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

Key update: An additional question regarding interim efficacy or safety analysis was added to the “scientific importance of the study” section.   

Scientific Importance of Study

D. Is an interim efficacy or safety analysis included in the study design of this protocol: 

  • Yes   
  • No 

If not Included, provide the justification of not including it in the study design. 

For industry sponsored trials, the justification of not including efficacy or safety analysis in study design should be discussed with the sponsor.

In case of any questions, please reach out to the SRC office at src-office@stanford.edu

Kindly make sure you are using this revised version going forward. CCTO intake will reject all the old versions of PSOS if they have a CRG meeting date of February 15 or later.

Amendment Submissions to the SRC

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Scientific Review Committee (SRC) would like to remind the research teams to kindly submit all protocol amendments through intake for SRC review. SRC will then assess these amendments to see if they involve changes to protocol design, endpoints, risk, sample size etc. The non-reviewable amendments will be documented in OnCore as `SRC review not required’. Submitting all protocol amendments will ensure that the `SRC reviewable’ amendments are not missed.

In case of any questions, please contact us at src-office@stanford.edu.

SRC Submission Requirements: Updates

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Effective July 1st, 2020, all new protocols submitted for SRC review now require:

  • CRG Priority Score Form in addition to
  • PSOS Form and
  • Flow charts (applicable to all interventional trials)

CRG Priority Score Form:

Any protocol submitted to SRC that has a PSOS sign-off date of 1 July 2020 or later must also submit the priority score form.

  • Retrospective documentation of any studies approved by the CRG in July 2020 and

Prospective for all studies reviewed by the CRG.

  • Studies that undergo review by more than one group or CRG; originating CRG should complete the CRG Priority Score Form and provide to the collaborating group for their review process
  • The CRG Priority Form should be reviewed along with the PSOS form at the CRG meetings and signed off by the CRG leader.

This will allow documentation of the process of protocol selection and prioritization at the CRG Level.

  • The Initial PSOS Form has been updated to remove redundancies between the Priority score form.

SRC PSOS Forms and CRG Priority Form can be downloaded from theSRC webpage:

https://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

Submissions for SRC review should be made via CCTO Intake at: https://med.stanford.edu/ccto/request.html

  • Please note the Priority score form can be uploaded to the “CRG Priority Score Form” under the section “New Study Request (Document Attachments)” in the redcap CCTO intake application. This is a mandatory field. 
  • Please reach out to Sharmila @ ccto-intake@stanford.edu for any technical difficulties.

SRC Protocol Statement of Support (PSOS) Forms Available July 1, 2020

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SRC PSOS forms (initial and renewal) have been streamlined and updated and will be available to download July 1st, 2020.  These updated forms should be used for any studies reviewed from this date onwards.

SRC website:

https://med.stanford.edu/cancer/research/trial-support/src/research-groups.html

Please note there is now only one PSOS form that can be used across all CRGS: We have removed the CRG member list, instead CRG attendee names can now be added to the form.

CRG participants that need to be present for the study review remains the same:

  • Initial PSOS: At least 3 CRG members other than the PI
  • Renewal PSOS: At least 2 CRG members other than PI

The following are the major changes that were made to the SRC PSOS forms:

  • Only 1 PSOS form (initial and renewal) can now be used by all CRGS
  • CRG specific forms have been removed.
  • CRG Attestation: CRG leader/designee signing the PSOS form, will need to provide a rationale related to the importance of the study in the CRG`s study portfolio
  • Initial PSOS has the following updates:
  • Added a question related to the inclusion of underrepresented population
  • Staff resources section updated to include OPAL Score

Reminder From SRC : Completing PSOS Form (Protocol Statement of Support)

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Per the current SRC policy, the minimum annual accrual goal at Stanford needs to be 5 or more. This is applicable for all disease categories that are not rare.

A rare disease is defined as having the incidence rate of 5,000 newly diagnosed cases of any specific cancer per year.

The committee wants to ensure effective utilization of resources that are needed to open a research protocol, hence the requirement.

This is effective immediately. The PSOS templates will be updated soon to reflect this as well. 

If you have any questions or concerns regarding this, please feel free to contact us  at src-office@stanford.edu

SRC Team