Trial Activation Process at SCI

• 1. Biostatistics
• To arrange a biostatistics consultation, please see the Spectrum Study Navigator website.
• 2. Protocol development

•  If you are the Stanford author of a cancer clinical study that will be administered at Stanford, the Scientific Review Committee (SRC) requires that you use a standardized template for your protocol document. 

1.  IND/IDE (Investigational New Drug/ Investigational Device Exemption)

• Request CCTO assistance 
• Documents needed for IND/IDE submission include:
  •  Completed protocol
  • Form FDA-1571 - Investigational New Drug Application: Instructions 
  • Form FDA-1572 - Statement of Investigator: Instructions, FAQs
  • Form FDA-3454 - Financial Interest and Arrangements of Clinical Investigator or Form 3455 Disclosure: Financial Interest and Arrangements of Clinical Investigators.
  • Form FDA-3674 - Certification of Compliance: Instructions
  • Investigator’s Curriculum Vita
  • Medical license
  • Letter of authorization of cross-reference from the drug or device manufacturer, if applicable from the drug or device manufacturer

2. IRB submission
Stanford’s Institutional Review Board (IRB) is a committee that is formally designated to approve, monitor, and review research involving humans in order to protect the rights and welfare of the research participants.

• Request CCTO assistance
• Complete online IRB application, called e-Protocol, using your SUNet ID.

3. OnCore™ registration

OnCore is Stanford’s centralized web based system for tracking cancer-related clinical research. Protocol and subject registration in OnCore is a requirement.

Contact OnCore to determine if OnCore registration is required for your protocol.

• Register study with OnCore by completing the entire online Protocol Registration Form. The Protocol Registration Form is used to create the protocol record in OnCore and the Stanford Clinical Trials database and subsequently ClinicalTrials.Gov. Studies must be in OnCore prior to Scientific Review Committee review. An OnCore protocol number will be sent with an email confirming OnCore study registration.

• The CCTO will download all documents from eProtocol and attach them into OnCore. These documents are accessible by the research staff, SRC and DSMC though OnCore.
• Contact the OnCore Team for more information on accessing OnCore.

4. SRC review:

The Scientific Review Committee (SRC) is charged with providing peer review of local and national research protocols involving cancer subjects at the Stanford University,  Stanford Health Care, and Stanford Children's Health. The SRC review can be a concurrent process with IRB and IND submission.

• Determine if SRC approval is required
• Contact the appropriate Clinical Research Group (CRG) program chair and request the protocol document to be reviewed. Once the CRG chair signs the completed Protocol Statement of Support (PSOS) form, submit it to SRC-Office@stanford.edu.
• Eligibility Flowchart  for interventional studies: Indicate on the appropriate CRG flowchart where your protocol fits in relation to other studies currently open or planned (see flowchart instructions). If the appropriate flow chart does not exist, create a new one. Send completed flowchart to SRC-Office@stanford.edu.
• Once the study is registered with OnCore and the PSOS and corresponding flowcharts have been are received by the SRC, your protocol will be assigned an SRC meeting date.

5. CTRU review
The Stanford Clinical Trials Research Unit (CTRU) is a clinical research facility that provides all of the components essential to clinical research, including laboratory services, computer systems support, nutrition services, nursing support and biostatistics consulting. To obtain services, complete a CTRU application form in Study Navigator.

• Request CCTO assistance with CTRU application.

6. Prepare regulatory documents

Request CCTO assistance.

• For industry-sponsored trials, the sponsor will provide investigators with specific study regulatory related documents and their corresponding instructions.
• Stanford specific regulatory documents

7. Budget and contract

• The CCTO develops, negotiates, and finalizes budgets for all industry sponsored cancer related studies. The CCTO will assist in completing all necessary budgetary forms. Request CCTO assistance.
• Concurrently, the Office of Sponsored Research (OSR) will begin contract negotiation.
• Once the final budget has been completed by the CCTO, the budget is then reviewed and signed off by  the Research Management Group (RMG).
  
• After final budget sign off, and all committees have approved the study, OSR will execute the contract agreement.
• Once OSR has executed the contract, a Notice of Award (NOA) will be issued and a Project Task Award (PTA) will be assigned to the study. If the study is a cooperative group study or part of a National Institutes of Health (NIH) grant and has a pre-existing NOA a separate NOA will not be issued.
• Setup 98 Account: This allows certain charges to be sent to the PTA account.

1. Conduct site initiation visit (for industry sponsored trials only) and study start-up meetings with pharmacy, CTRU, clinic, Infusion Treatment Area (ITA) and others as appropriate. If you are using the ITA, submit the Research Study Quick Reference form and submit it as instructed in the form.

2. OnCore will notify investigators by email once all the proper signoffs and approvals are in place and the study is ready to be opened to accrual. The PI or study coordinator must provide the actual date the study is opened to accrual. Once you have opened the study to accrual, email this date to CCTO-OnCore@stanford.edu. It is important to Stanford’s SRC and as well as for reporting purposes to the NCI that the open to accrual date be accurate.

3. Participant recruitment

• CCTO posts new interventional trials on SCI  website as well as on ClinicalTrials.gov. Observational study postings are optional. For assistance with web postings please contact ccto-website@stanford.edu.
• Clinical Trials Listing Booklet The booklet (commonly known as the Pocket Guide) is a quarterly guide published for healthcare professionals. It provides a list of cancer clinical trials currently open to accrual at the Stanford Cancer Center.  For assistance with the guide please contact the CCTO’s Clinical Trials Outreach Specialist or call 650-498-7061.
• The CCTO’s Cancer Clinical Trials Outreach Specialist can also assist Investigators with identifying additional recruitment strategies.

4. Participant enrollment

• The SRC requires that all study participants be entered into OnCore within 5 working days of the date consented. See: Cancer Study Participant Registration Instructions.
• Register participants with Patient Financial Services.
• Notify the investigational pharmacy of each patient enrolled who will need investigational drug.
• Place all regulatory documents in study binder.

5.  Report adverse events (AE) and deviations

Reporting to SCI.  Report all SAEs CTCAE Grade 3 and above to ccto-safety@stanford.edu for institutional record keeping. Investigators should send completed CRFs and follow up reports only; do not send lab reports or copies of medical records. Use Stanford secure email and indicate the OnCore or eProtocol number in the subject line. Report protocol deviations into OnCore.

Reporting FDA.  For all Sponsor-investigator IND studies, submit all SAE events to the IND within the specified timeframes.

SOP: Documenting and Reporting Protocol Deviations 

Reporting to Stanford IRB. Report Unanticipated Problems Involving Risks to Participants or Others (UPs) directly to the Stanford IRB using the “Report” option in eProtocol. Refer to IRB policy guidance Events and Information that Require Prompt Reporting to the IRB for further information and additional guidance.

6. DSMC

• The Data and Safety Monitoring Committee (DSMC)  ensures the safety of participants in all cancer clinical trials by reviewing grade 3 and above adverse events and protocol deviations.  It is also responsible for auditing for protocol compliance, data validity and integrity of institutionally sponsored, investigator authored treatment trials.
• For Stanford Investigator-initiated treatment studies, the DSMC coordinator will notify you when your study is to be audited.  Protocols are audited minimally on an annual basis. Get more information on DSMC operations plan here. 
• For preparation assistance for an upcoming DSMC review request CCTO assistance.
• For Investigators contacted by an industry sponsor in regard to an upcoming monitoring session email ccto-admin@stanford.edu to gain access to a monitoring conference room.

7. FDA audit

• Notify both the Director of Clinical Research Operations and ccto-regulatory@stanford.edu if your study has been chosen for an audit.  The CCTO Regulatory Manager will assist you with your audit preparation and notify the appropriate Stanford representatives.