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.
- Research Orientation to SCCA - version date 10/5/15
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.
- RIO Requirement Guidelines
This document is designed to guide you through the RIO Submission process, referencing required documents, when to complete, and where to submit them.
- Account Registration Form (PDF) - version date 02/03/2015
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 firstname.lastname@example.org.
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 1/28/16
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. Please see the CRBB Coverage Analysis Checklist Instructions for information on how to complete the form.
- 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 10
Use this tool to create a pricing request for research billable services at the SCCA. For questions on how to complete this tool contact email@example.com or call Abby Ewing at 288-8209.
- SCCA RIO Submission Form
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 firstname.lastname@example.org.
- Radiology Clinical Research Application Form (MS Word) - version date 12/3/14
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.
Radiology Research Committee RadRRR@uw.edu
Voicemail: (206) 616-0962
Fax: (206) 685-9096
Clinical Research Budget and Billing Office (CRBB) email@example.com
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
The OncoRad service has provided imaging assessments of response for patients on oncology clinical trials since February 2009. Assessments are performed by University of Washington radiologists. Since September 2014, assessments have been performed using the Tumor Imaging Metrics Core (TIMC), a web-based application developed and supported by the Dana-Farber/Harvard Cancer Center.
- Fees – Effective 10/1/15 the OncoRad program converted to a cost center. As a result of converting to a federally mandated cost center, by law we must charge for all OncoRad services. The conversion to a cost center was delayed for over a year to allow investigators with NIH/NCI and PI trials time to incorporate the new rates into their budgets.
- Protocol Set-Up Fee for each evaluation criteria.
- Some protocols may require multiple assessments using different criteria at each timepoint.
- There is an additional fee for modifications to the standard published criteria.
- Report Fee for each report at each time point.
- Fees are based on the complexity of the criteria and the tools/expertise needed to complete the case.
- Rush Fee for providing reports in less than 4 hours; applicable only if the OncoRad radiologists are able to accommodate the rushed request.
- New Baseline Fee each time a new baseline is required, for example, when a patient crosses over to a new study drug or when a subject continues on study therapy beyond progression (after PD).
- Re-Review Fee for re-reads and corrections required due to insufficient or incorrect information in the protocol request or read request, or protocol changes that were not reported to OncoRad.
- All prices are subject to change without notice.
- Protocol Set-Up Fee for each evaluation criteria.
- OncoRad/TIMC Help Desk – firstname.lastname@example.org
- Please email the OncoRad help desk for all questions regarding OncoRad/TIMC:
- Protocol registration
- Please email the OncoRad help desk for all questions regarding OncoRad/TIMC:
- 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.
- CRBB Requirements Flow Document (PDF)
- Billing Entity by Site of Practice (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)
- HSCT Protocol Specific Preprinted Order Templates & Guidelines (PDF)
- Solid Tumor Protocol Specific Preprinted Order Guidelines (PDF)
These guidelines were developed to assist research staff with creating solid tumor/non-transplant protocol specific preprinted: chemotherapy, supportive therapy, prescription and scheduling request orders.
Policies & Procedures
- Authorized Entries into Medical Records
This policy provides details on individuals that are authorized to make entries in a patient's medical record.
- Informed Consent Research Consenting
The purpose of this policy & procedure is to describe the informed consent process for clinical trials or other research studies occurring at the SCCA.
- Informed Consent: Use of Interpreters in the Informed Consent and Assent Process for Research Protocol
The purpose of this policy is to detail when to use an interpreter for informed consent and assent and how to document such use.
- Medical Records Request for Research Purposes
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.
Use of Clinical Space for Research-only Patient Activities
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
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.
- Adverse Event Reporting
- Rights of Patients Participating in Clinical Trials
- Withdrawal from a Research Study
- Lab Specimen Collection and Handling Manual, 25th Edition - version date 9/17/2015
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.
- Alliance Lab References
Alliance Lab quick reference guide to identify available lab panels at SCCA (calculated tests not included).
- 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 Revenue Cycle Overview - Research Staff Training Ongoing
The Research Revenue Cycle process assures accurate billing compliance for research activities. This presentation is put together by the SCCA Clinical Research Billing Education Specialist to provide research coordinators with an overview of the research revenue cycle process, the types of billable services, and the available resources for training, key contacts, and websites.
- 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