1. SCCA Orientation to Research
August 1, 2017
Jen Maxon
Research Integration Program Manager
Research Implementation Office
Seattle Cancer Care Alliance

2. Welcome!
This orientation is intended for those individuals who will be involved in the conduct of research at the SCCA.
Topics:
SCCA and our role with research
Introduction to the Research Implementation Office (RIO)
Submitting new protocols and the implementation review process
Protocol specific orders and powerplans review process
Other information (FYIs)

3. What is the SCCA?
The SCCA brings together the outstanding adult and pediatric oncology patient care services of three world-renowned institutions:
Fred Hutch
University of Washington
Seattle Children’s

4. Why does Research matter at the SCCA?
At SCCA, our goal is to turn cancer patients into cancer survivors.
To do this we must continually seek out new ways to prevent, diagnose and treat it.
This can only be done through research.
Research is how we advance the standard of cancer care/treatment.

5. SCCA’s Research Role and Responsibility
Our role:
Provide sites of practice for clinical research.
Provide SCCA staff who support the conduct of clinical research.
Our responsibility:
To ensure that the SCCA is a “safe and compliant environment” for the conduct of human subject research.

6. Research at the SCCA
All protocols/research activity that will take place at an SCCA site or involves SCCA patients must be reviewed by SCCA’s Research Implementation Office (RIO).
This requirement includes emergency treatment use activities (aka compassionate use).

7. What is an SCCA site?

8. Research Implementation Office (RIO)
Our primary function:
Facilitate 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.
We are customer service orientated and dedicated to assisting you however we can with your study start-up needs at SCCA as well as with any needs that arise throughout the lifecycle of the study.

9. Research Implementation Office (RIO)

10. When do I submit a study to RIO?
As soon as you have received a Consortium Protocol number from the Clinical Research Support Office (CRS)
Before Scientific Review Committee (SRC)
Before Institutional Review Board (IRB) submission;
See “Study Start-up” Map created by CRS.

11. When do I submit a study to RIO?

12. How do I submit a study for review?
Via the Study Review and Management Portal (sRAMP);
Go to:
Review the Training Materials posted on the site:
Study Review and Management Portal User Guide
Quick Reference Guides
Supplemental Materials
Pay close attention to info on “standards” and “minimum submission requirements”;
Note that your submission can be marked incomplete and returned to you (will not move forward in the review process).

13. How do I submit a study in sRAMP?

14. SCCA RIO Submission Form
Purpose: To facilitate the implementation of research protocols that will utilize the SCCA as a performance site.
Captures:
Study participant information;
Performance site(s) and Service Area involvement;
Billing categories for planned activities;
Answers to common operational questions;
Details for protocol related activities specific to Service Area.

15. SCCA RIO Submission Form Example
General Info
Required
Research Pricing
Info for Svc Areas
CPOE
Consider
Special Requests

16. What happens next?
Within 2 business days, RIO will evaluate the submission in sRAMP (aka “Triage”).
If components are missing, we will mark “incomplete” and alert you via discussion thread to fix and resubmit; or:
Send a follow-up discussion thread in sRAMP outlining items which need clarification/adjustment within the sRAMP, as well as:
Identify the level of Implementation Review required and we will set tentative implementation review date.

17. What does Follow-up from RIO contain?
Acknowledgement that we’ve reviewed the submission;
Information on items which require a response or modification before the study can proceed;
Requests are presented in outline format and categorized by submission components:
Parts 1-3 of sRAMP
RIO Submission Form
SCCA Pricing Table
Billing Grid
Implementation Review (IR) date or E-review confirmation;
Due date for response (3 business days).

18. What is a “Full” Implementation Review?
Multidisciplinary review of research protocols;
Protocols reviews are scheduled based on patient population:
Solid Tumor/Heme= Clinical Trial Implementation (CTI)
Blood and Marrow Transplant & Immunotherapy = Protocol Implementation (PIM)
Review determines if the SCCA is equipped and staffed to support this research & identifies any gaps prior to initiation of study.

19. Service Areas involved in the Implementation Review

20. What is expected of the research team at the meeting?
*Study staff must be familiar with the protocol they are representing, especially the areas where the research intersects with clinic activity;
The questions and discussion are generally around how to make the research “fit” in with the standard clinical processes.
Recommendations are also made regarding the use and content of Preprinted Orders and PowerPlans.
*The implementation review is most effective when the person who will be coordinating activity after the study opens is present for the discussion.

21. What happens after the meeting?
You will receive a summary detailing items that require follow-up/action before the study opens;
The Research Implementation Review Summary (RIRS) will be placed by RIO in sRAMP within 5 business days;
You will progress through the remaining stages of the budgeting and review process;
You will initiate the Research Account Activation process following IRB approval (Research related activity should not be scheduled until a RRR account has been activated); SIV must be complete prior to Research Account Activation.
RIO will send an notification alerting all impacted Service Areas and Performance site representatives that the study is officially open.

22. What about changes?
For studies in sRAMP, review the “Change Request” process in training materials.
A new RIO Submission Form is required for assessment of additional implementation needs/impact. Examples:
Adding performance sites;
Adding new services/service areas;
Operational changes such as those related to medication administration; new arms or drugs and dosage changes;
Changes to billing designations (e.g. originally billing to research now billing to patient).
RIO will determine if there are additional review needs based on the changes and ensure the impacted areas have an opportunity to comment on the changes.

23. What do I do when a study closes?
For studies in sRAMP, review the “Study Close-out” process in training materials.
For pre-sRAMP (aka Legacy) studies, alert when the study is closed and there is no more research billable activity.
RIO will notify impacted Service Areas, Performance Sites representatives and the Research Billing Office that the study has closed and will archive the related files.

24. Protocol Specific Orders (PPO) & PowerPlans (PP)
All orders must be entered into ORCA with the exception of those items which still remain on paper:
IDS-dispensed medications (chemotherapy orders and prescriptions); includes any medications dispensed from clinical Pharmacy as part of the treatment regimen
Cell-Related Orders (collection, processing and infusion)
Others: Nuclear Medicine & Oncoplex
Protocol Specific PPOs and PPs are highly recommended, but are not mandated by the SCCA;
Generic PP templates are available in CPOE for use by study staff;
SCCA Clinical Information Services (CIS) is available for assistance through the Help Line ( ).

25. Protocol Specific PPO/PP Review Process
Complete and submit PP build template tool to CIS;
Draft paper orders;
Submit draft paper orders and draft PPs word downloads to RIO as one complete package to initiate review.
BMT and IMTX may submit orders package after the Protocol has been reviewed at PIM
RIO will assist with standard order formatting needs but can’t assist with content development or editing of content.
RIO will package PPOs (drafts or previously approved) and PPs together prior to circulating for in-person review at PIM.

26. “Protocol Specific PowerPlan & Preprinted Order Review Process Flow”
What happens at 2nd Implementation Review?
Comments on the package will be returned to you for response;
RIO will facilitate discussion and track to action items as well as additional review to confirm changes;
Modifications as an outcome of review:
Must be made by study staff for paper orders
Are made by CIS to PPs (working with study staff)
Study staff will re-submit the complete package (paper orders & PPs) to RIO
RIO will initiate review of the orders package by SMPG.
RIO will initiate final approval of the orders package with the PI.
Please see Hand-out:
“Protocol Specific PowerPlan & Preprinted Order Review Process Flow”

27. Research and Patient Safety Net (PSN)
Reporting deviations (e.g. errors – actual or potential) and unsafe conditions helps SCCA identify areas of system vulnerability and opportunities for improvements.
We use Patient Safety Net (PSN).
All variances are tracked / trended by the Quality Dept. and are reviewed to identify potential system improvements that can benefit patients, families and staff.
PSN does not replace IRB reporting requirements and is not to be used for reporting billing related issues or staff injuries.
New: SCCA Research Integration Dept. reviews PSN reports to identify and track instances of protocol non-compliance.

28. Want more information or have a question?
Research Implementation Office
Phone:
SCCA Research Staff Resources:
sRAMP portal:
You may also want to schedule a one-on-one orientation for RIO processes in order to ask questions related to your specific role with research. If you are interested, please the RIO.

29. THANK YOU