SRC Submission Process

Initial Application

  1. All applicable investigator Initiated studies must comply with SCI guidelines and appropriate protocol templates prior to either SRC or IRB submissions. 
  2. All Investigator-initiated protocols submitted to the SRC will be pre-reviewed prior to the scientific review by the SRC; the purpose of the pre-review is to ensure that protocols contain all the required elements and they are organized in a consistent manner in the appropriate format.  The Checklist is intended to be helpful in the protocol writing process. Protocols that lack the necessary information will not be assigned SRC reviewers until the protocol has been revised.  

    Please allow sufficient time for this pre-review and revision (if necessary) process.  We will make every effort to be prompt in sending PIs the comments from the pre-review to help expedite the protocol development process.  The pre-review will allow the SRC reviewers to focus on the scientific merit of research protocols and to ensure they conform to the research objectives and priorities of the SCI. 
  3. An IRB application must be submitted to Stanford’s Administrative Panels on Human Subjects prior to SRC submission. 
  4. Complete the Protocol Registration Form.  
  5. Complete a Protocol Statement of Support (PSOS) form for the appropriate Clinical Research Group (CRG). 
    1. Solid tumor studies involving multiple disease groups require a PSOS form, flow chart, and identification of a co-PI for each CRG from which the study plans to recruit participants. The exception to this are Phase I trials being conducted within the Developmental Therapeutics CRG. 
    2. If your study does not fall under one of these groups please use the various/other PSOS. 
  6. All interventional trials (with the exception of pediatrics) must complete a Flowchart. Download the appropriate CRG flowchart. Indicate where this protocol fits in relation to other studies currently open or planned (see flowchart instructions). If the appropriate flowchart does not exist, create a new flowchart using the blank protocol template.  Mark up a copy by hand and submit it to the SRC. For questions or assistance with flowcharts contact spelta@stanford.edu.    
  7. Email or Fax the PSOS and flowchart to the SRC/(Fax) 650-725-9204

 

SRC Application Forms & Flowcharts

Resources

Scientific Review Committee

Data & Safety Monitoring Committee

Quality Assurance Program

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