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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 environments to ensure that all operational issues are addressed prior to study participant accrual.  Please feel free to contact RIO if you have any questions about conducting research at the SCCA.

 

General Information

  • Research Orientation & Compliance Manual
    This manual provides information about doing research at the SCCA because supporting the conduct of cancer clinical research and education is part of our mission. Some of the topics covered include: Human Subjects Research Roles & Responsibilities, SCCA Committees involved with Protocol/Clinical Trial Implementation, Research Billing Process & Compliance and Informed Consent Process Guidelines.

Forms

  • AAA Account Registration Form (also included on the last page of the CTPI form) (MS Word)
    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 AAA account being registered.  Institutional Review Board (IRB) approval must be received by RIO before the AAA account number 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 AAA account information has been announced by RIO.
     
  • Clinical Trial Planning and Implementation (CTPI) form (MS Word)
    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 AAA 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 (MS Word)
    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.
     
  • Protocol Amendment Summary Form (MS Word)
    Research staff must complete this form for all solid tumor/non-transplant protocol amendments. 
     
  • RECIST Template (MS Word)
    Response Evaluation Criteria in Solid Tumors (RECIST) imaging interpretation is a requirement of many clinical trials.  This procedure and RECIST template were created to standardize the process for requesting and obtaining RECIST readings at the SCCA.
     
  • 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 AAA 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 please go to: http://uwmedicine.washington.edu/Research/ResearchBudgetBilling/
     
  • Path of a Clinical Trial  (PDF)
    This flow contains basic information regarding the path of a clinical trial at the SCCA and describes the Clinical Trial Implementation (CTI) and HSCT Protocol Implementation (PIM) committee roles in the review and approval process.
     
  • Protocol Related Lab Testing Decision Tree (Coming soon…)

Guidelines

  • HSCT Protocol Specific Preprinted Order Templates & Guidelines (Coming soon…)
     
  • 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

  • Informed Consent Research Consenting (PDF)
    The purpose of this policy & procedure is to describe the informed consent process for clinical trials or other research studies occurring at the SCCA.
     
  • Infusion Services Research Billing  (PDF)
    This policy applies to research staff involved in studies where Infusion Services activity (e.g., nursing and supplies) will be billed to the study via a AAA account.
     
  • Medical Records Request for Research Purposes (PDF)
    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 (PDF)
    Electrocardiograms (ECGs) are commonly required procedures associated with solid tumor clinical research trials. This procedure provides instructions to ensure that research-related ECGs are performed and billed correctly.
     
  • Professional Fee Sheet for Research Related AAA Billable ECGs (PDF)
    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 AAA-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 (PDF)
    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. 

Training

  • 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.