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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 researchbilling@seattlecca.org.

  • 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 Trial Planning and Implementation (CTPI) form (MS Word) - version date 6/30/14
    The purpose of this form is to facilitate the implementation of clinical trials that will utilize the SCCA as a performance site by providing pricing for clinical services which will be charged and invoiced to the study budget via a RRR account.  This form must be completed to receive pricing for study feasibility analysis and budget planning or to initiate scheduling an implementation review.

  • 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.

  • OncoRad Protocol Set Up (MS Word)
    The OncoRad Protocol set-up form describes the process and information needed to set up a new protocol in OncoRad. Protocols must be entered into the system by the OncoRad team before patients can be entered and before reads can be requested. For questions related to this form or the process, email oncoradsupport@fhcrc.org.

  • OncoRad User Access (PDF)
    The OncoRad User Access form is required for all new users who need access to OncoRad. Access is required in order to enter and view patient data and request reads.  

Radiology/Imaging Pricing 

  • Radiology Clinical Research Application Form (MS Word) - version date 9/18/13 
  • 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

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.