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Research Staff Resources

The documents below are intended for individuals involved in the conduct of research at Seattle Cancer Care Alliance (SCCA). If you have questions about this information or are looking for something that is not posted, please contact the Research Implementation Office (RIO) at (206) 288-6607. 

RIO facilitates the implementation of new research studies into the clinic and inpatient oncology environments to ensure that all operational issues are addressed prior to study participant accrual occurring.

General Information

  • Research Orientation to SCCA - version date 1/29/13
    This presentation provides an introduction to the process of research at SCCA. It covers the purpose of research at SCCA, the Human Protection Program, the roles and responsibilities of the RIO and study staff, the path of clinical trials, and an overview of the implementation process.  

Forms

  • Account Registration Form (PDF) - version date 6/24/14
    This form is used after a study has received pricing information and undergone an implementation review. A study budget number must be assigned prior to a research account being registered.  Institutional Review Board (IRB) approval must be received by RIO before the research account information (RRR Name/RS Study Code) can be distributed. The standard turn around time is 3 business days (provided all CRBB requirements have been met).  Patients should not be scheduled for research related activity until the research account information has been announced by RIO.
  • Anticipated Research Services Checklist
    Complete this form to route SCCA facility charges to RRR accounts for all research activity occurring in the Women's Center, Gen Onc/4th floor, Procedure Suite, Infusion Services, Apheresis and Transplant Clinics.  For questions related to this form or the process, contact the Research Billing Office at researchrc@seattlecca.org.

  • Application for Approval to Use Radiation with Human Research Subjects (HSRAC Forms 1 and 2)

    Any protocol that involves the use of experimental radiotherapy at University of Washington (UW)* or Seattle Cancer Care Alliance (SCCA) licensed facilities requires review by the Human Subjects Radiation Approval Committee (HSRAC). IRB reciprocity agreements do not apply to the use of radiation and radioactive materials when used at a UW site.  The HSRAC may issue Approvals for certain uses of radiation in human subjects. All investigators planning to do research on humans using any type of radiation (x-rays, nuclear medicine, radiation therapy, etc.) must apply for Approval to Use Radiation in Human Subjects.

    *UW-licensed facilities include the University of Washington Medical Center and Harborview Medical Center

  • Clinical Trial Activity Summary (CTAS) (MS Excel) - version date 3/12/14
    A Clinical Trial Activity Summary (aka Activity Summary) is required for all therapeutic and diagnostic studies submitted to the Research Implementation Office (RIO) for research pricing and/or implementation review for services occurring at SCCA as of Sept. 1, 2012. The primary purpose of the Activity Summary is for facilitating the financial clearance process for clinical trials.

  • Clinical Trials Policy Coverage Analysis Checklist for Clinical Research Studies (PDF) - version date 11/16/12
    This checklist is a requirement for all studies and is used to provide guidance for the accurate billing of research study clinical services, items and tests.  It must be signed by the Principal Investigator and Department Director/Designee prior to submission to RIO.  If you do not know who should sign as the Department Director/Designee for a particular study please call (206) 288-6607

  • ORCA Research Powerplan Build Requests
    This link will provide you with the ORCA Research Powerplan Build template for requesting build of both SCCA and UW powerplans and a Quick Reference Guide on how to apply research modifiers to electronic orders. 

  • SCCA Pricing Request Table - version date 12/05/14
    Use this tool to create a pricing request for research billable services at the SCCA. For questions on how to complete this tool contact researchpricing@seattlecca.org or call Abby Bixby at 288-8209.

  • SCCA RIO Submission Form version date 12/10/14
    This form must be completed for any research protocol that will utilize the Seattle Cancer Care Alliance as a performance site.  SCCA RIO, Operational managers or their designee, Implementation Review Committee members, Clinical Research Billing and the Compliance will review the submitted form and identify any issues that may need to be addressed prior to the study opening.  Completed forms should be submitted to rio@seattlecca.org.

Radiology/Imaging Pricing 

Completion of this form is required for all studies involving imaging services at SCCA and UWMC.  Information contained in this form assists the Radiology Research Committee during the review process.

For UWMC only pricing requests contact:
Radiology Research Committee RadRRR@uw.edu
Voicemail: (206) 616-0962
Fax: (206) 685-9096
 
Clinical Research Budget and Billing Office (CRBB) crbb@uw.edu
Phone: (206) 543-7774
Fax: (206) 543-8501
CRBB Web-site: (requires UW Net ID)
UW Medicine CRBB website: (does not require UW Net ID) 

For more information on the UWMC pricing process and the clinical research handbook pricing pages, or contact the CRBB directly.

For general information regarding clinical research at UW

OncoRad Transition to TIMC – Going Live 9am 9/29/14
OncoRad will go off line at noon on Friday 9/26 for the conversion and will be unavailable over the weekend. Service will return 9am Monday 9/29.

  • Presentation “OncoRad Future” – Carolyn Wang, MD, 8/26/14
    This presentation provides an overview of the current and future OncoRad program in a meeting/webinar with investigators and research staff.  The presentation was followed by a Q&A session.  
  • Training – Contact Diane Guay drguay@uw.edu
    TIMC is sponsoring training sessions before we go live. Future training will be through self-review of a user guide accessible through the website and consultation with Diane Guay.
     
  • User Guide – Draft v. 8/25/14
    TIMC provided a user guide for study staff. This will be modified before the transition to better reflect the UW/TIMC interface. Link to user guide.
     
  • Estimated fee schedule – Anticipated changes effective 10/1/15. Link to fee schedule.
    We will be converting the OncoRad program into a cost center. As a result of converting to a federally mandated cost center, by law we must charge everyone the same fee for the same service. By law we will not be able to provide OncoRad interpretations free of charge. We recognize that this will be a difficult transition for NCI and PI initiated studies. Thus we will delay the conversion to a cost center for 1 calendar year in order to allow investigators the chance to incorporate the new rates into their budgets.  

    The estimated fee schedule shows projected rates effective 10/1/15 compared to the current rates.  The overall rates will be going down assuming overall case volume remains the same. Thus for most investigators, the impact will be favorable

  • Request to Reduce or Waive SCCA Fees for Research Activity
    This form is required to request a reduction in the price or waiving the costs of a clinical service occurring at SCCA that should be covered by a research study budget.

  • Research Lab Request Form and Support Documents
    This link will provide you with Research Lab Request forms, process flows, and examples.   

  • Research Specimen Scheduling Instructions and Example
    A description of the overall process for research specimen processing, including instructions for completing the template along with a template example for reference purposes.

  • Research Specimen Scheduling Template
    This form should be used for any research specimens that will be processed by the Research Specimen Processing (RSP) lab staff in either the Research Specimen Processing Facility (RSPF) space at the SCCA (G7-304) or in the Arnold Building (M5-A224).

  • Research Study Closeout Notification
    The Research Study Closeout Notification is used to notify CRBB when a study is closed. This form should be submitted when all research billable activities are complete as it will result in the research account being closed. 

  • SCCA Institutional Biosafety Committee (IBC) Submission form (MS Word)
    All studies which involve recombinant DNA (rDNA) and/or infectious agents and will occur at the SCCA must be reviewed by the SCCA IBC.  Note: The IBC meets the 1st Thursday of each month and materials must be submitted to RIO 3 weeks prior to the meeting date for consideration.

  • Use of PHI Data Sets for Research Purposes Worksheet (MS Word)
    This form must be completed by any Researcher/Principal Investigator requesting data for research purposes.

  • Use of Residual Specimens for Research Worksheet (MS Word) 
    This form must be completed by any Researcher/Principal Investigator or his/her designee requesting residual specimens for research purposes.

  • Witness Attestation Form/Consent Short Form
    This document is to be used per the SCCA's Use of Interpreters in the Informed Consent and Assent for Research Protocols Policy and Procedure.
     

Flow Charts

  • CRBB Requirements Flow Document (PDF)
    If UWMC is a performance site for a study or there is a University of Washington Physicians (UWP) professional fee component to the SCCA pricing, the Clinical Research Budget and Billing Support Office (CRBB) requirements must be met prior to establishing the RRR account.  This flow was developed to assist research staff with determining requirements for new studies.  For more information on the CRBB and up-to-date information on their requirements click here.

  • Process for Implementing FHCRC Studies at Seattle Children's (PDF)
    This flow outlines the general steps for implementing a FHCRC study at Seattle Children's. If research protocol required services will need to be delivered to a research participant by Seattle Children's, it is required that the study be established in their systems so they can be delivered in a safe and timely manner.

  • Protocol Related Lab Testing Decision Tree (PDF)

Guidelines

Policies & Procedures

  • Informed Consent Research Consenting (MS Word)
    The purpose of this policy & procedure is to describe the informed consent process for clinical trials or other research studies occurring at the SCCA.

  • Medical Records Request for Research Purposes (MS Word)
    This document outlines the process necessary to request the patient’s paper and electronic medical record for research study review purposes.

  • Research Related ECG Roles and Responsibilities
    Electrocardiograms (ECGs) are commonly required procedures associated with solid tumor clinical research trials. The following guidelines provide instructions to ensure that research-related ECGs are performed and billed correctly.
  • Professional Fee Sheet for Research Related RRR Billable ECGs (MS Word)
    In order to ensure that research study participants are not financially responsible for research ECGs, the following policy and procedure was created.  This procedure requires   that study staff complete a professional fee billing sheet for each research related RRR-billable ECG. 

  • Use of Clinical Space for Research-only Patient Activities (PDF)
    This document outlines the policy for using examination and consult rooms in the SCCA Clinic for non-invasive, research-only activities.  Rooms for this type of activity are made available without cost to the study or the patient and will be scheduled based on space availability with priority given to patient clinical visits.
     
  • Use of Disclosure of PHI for Research (MS Word)
    The Health Insurance Portability and Accountability Act (HIPAA) requirements for the use and/or disclosure of protected health information for research contains a Privacy Rule which permits the SCCA, a covered entity, to use or disclose PHI for research under certain circumstances and conditions outlined in the attached policy. 

Reference

  • Lab Specimen Collection and Handling Manual, 23rd Edition  - version date 3/21/14
    This manual summarizes the requirements for collecting and handling specimens for testing in the Clinical Laboratories of SCCA. This is the current version and has been revised as part of our ongoing efforts to provide the best possible patient care.

  • Research Specimen Courier Information (MS Word) - version date 8/20/13 This document explains the hours of operation, contact information and details for scheduling Research Specimen Courier Transport.

  • Response to 21 CFR Part 11 (PDF)
    The attached document is the SCCA institutional response to 21 CFR Part 11. This letter mirrors the letter created by UW Medicine.

Training

  • Patient Safety Net (PSN) - Research Staff Training Ongoing
    PSN is an anonymous online reporting system used at Seattle Cancer Care Alliance to report unsafe conditions, near misses and events that cause harm or inconvenience to patients and visitors.  These slides explain how to access the PSN reporting system and describe the criteria for situations to report.
  • Research Charge Capture - Research Staff Training Ongoing
    The Research Charge Capture process assures accurate billing compliance for research activities. These slides were put together by the SCCA Revenue Cycle team to help new and experienced coordinators request accounts, track expenses, and submit accurate paperwork for scheduling and orders.
     
  • SCCA Clinical Trials Policy (CTP) - Research Staff Training Ongoing
    Medicare's Clinical Trial Policy (CTP) provides coverage of routine costs associated qualifying clinical trials.  These slides provide education and training to help you determine if your study is qualifying and how to comply with the CTP process for Consortium study participants with billable services at the SCCA or UW Medicine.

 


ORCA Research Powerplans

ORCA Research Powerplans