Clinical Research: Working with CRIS, Velos and...
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Clinical Research: Working with CRIS, Velos and UChart Clinical Research Forums in Pediatrics February 9, 2011 Suzanne Liv Page, JD Director, Clinical Research Initiation Services & Clinical Research Revenue Cycle Eric Ponce, MS-BME, PMP Senior Project Manager, Office of Research Information Management
Transcript of Clinical Research: Working with CRIS, Velos and...
Clinical Research: Working with CRIS, Velos and UChart
Clinical Research Forums in Pediatrics
February 9, 2011
Suzanne Liv Page, JD Director, Clinical Research Initiation Services & Clinical Research Revenue Cycle
Eric Ponce, MS-BME, PMP Senior Project Manager, Office of Research Information Management
Agenda • Subject Enrollment & Tracking Policy/FAQs • Jackson Requirements • Velos/UChart Overview • IDX vs. UChart: What’s Changed • Scheduling Research Visits in UChart • Possible Implications for Non-Compliance • Velos and ORIM Project Pipeline • Question and Answer
FAQs for Subject Enrollment Policy
Q: Is this a new policy?
A: No. It is a revised policy. The original policy became effective in 2006. The revised policy clarifies which clinical research projects require notification regarding consented subjects and clarifies that this notification must be received within 24 hours of consenting a subject.
Q: Does this policy apply to all clinical research studies?
A: No. This revised policy applies to clinical research projects involving human subjects in which (1) a drug, device or biologic is being studied and/or (2) a procedure, lab test or intervention will be performed. This policy does not apply to chart reviews, tissue banking or questionnaires.
Q: Does this policy apply to unfunded studies? Industry studies?
A: Yes. This revised policy applies to all clinical research studies that meet the criteria set forth in the policy, regardless of funding, or source of funding. For example, it applies to investigator-initiated unfunded studies, industry-funded studies and NIH funded studies.
FAQs for Subject Enrollment Policy
Q: Do I need to provide the notification within 24 hours of consenting a subject or enrolling a subject?
A: Yes. You need to provide the notification within 24 hours of consenting a subject.
Q: I am busy. Do I really need to do this within 24 hours of consenting a subject?
A: Yes. It is critical that the University is aware of all consented subjects as soon as possible. This information enables the University to track the subject’s billing and make sure all bills, for both research related items as well as those for clinical care, are correct. Accurate billing is an important component of University compliance, especially when billing governmental payers such as Medicare. This information also helps minimize incorrect bills being sent to subjects.
FAQs for Subject Enrollment Policy
Q: Can I just send the consent form or provide the subject’s name?
A: No. CRRC needs more than just the subjects name and study title to track the subject. For example, there may be many people named “John Smith” in the billing systems and we need to make sure we are tracking the correct subject on the correct study.
Q: What is Velos? How do I learn more about getting studies built in Velos?
A: Velos is software the University has licensed for tracking clinical research studies. If your study is built in Velos, subject notification is very simple and you will not need to submit the Enrollment Tracking Form. For more information on Velos, please contact Eric Ponce at [email protected] or 305.243.2314.
FAQs for Subject Enrollment Policy
Q: Am I also required to notify Jackson if I am using Jackson for the study?
A: Yes. In addition, if you are using any Jackson resources for your study, Jackson policy requires you to notify Jackson within 24 hours of consenting a subject.
Q: Does this replace current reporting obligations to the IRB?
A: No. You must still comply with all IRB reporting obligations, such as reporting serious adverse events.
Q: Who can I contact for more information about this policy?
A: [email protected], 305.243.7704.
Velos/UChart Overview
Velos/UChart Overview
Identify studies with documented, billable clinical procedures
Identify patients on a study & current status
Understand research vs. SOC visits
Identify the corresponding protocol visit for the clinical encounter
Review appointments and charges
Know which encounters involved an SAE and their related procedures
CRIS creates Coverage Analysis (aka Billing Grid). Studies set up in Velos.
Consent patients, enter data into Velos within 24 hrs. Information uploaded to UChart from Velos.
Associate encounters in UChart with corresponding study.
Enter notes in UChart naming the corresponding protocol visit. Closed encounter goes into CRRC queue.
CRRC reviews appointments and charges using billing grid as its guide.
Study Team flags UChart encounter as containing SAE. Goes into queue for CRRC.
IDX versus UChart
Item IDX UChart
University of Miami Appointments
See all appointments for research subjects
See all appointments for research subjects *Excluding Behavioral Health
Jackson Appointments No Access to Appointments No Access to Appointments
Patient Research Flag Only patients that were sent to CRRC had Flags
All subjects active on studies tracked by CRRC in Velos show as “Research Active”
UM Hospital Research Charges
CRRC reviewed only certain charges
CRRC reviews all Charges for research visits associated with studies
JMH Hospital Research Charges
No Hospital fees came into IDX from JMH
No Hospital fees come into UChart from JMH
UM Professional Charges Only Charges linked to the research case reviewed
CRRC reviews all charges for research patients when services rendered by UM physicians/personnel
Follow these 4 simple steps after you get access to the UChart System Step 1: Locate Patient and Make Appointment
Scheduling for Research in UChart
Step 2: Look for Department/Provider and Date Note: To help CRRC identify the correct encounter it would be good to add notes
Scheduling for Research in UChart
Step 3: Locate the next available time slot
Scheduling for Research in UChart
Step 4: Associate Appointment to Study Encounter
Scheduling for Research in UChart
False Claims Act
Institution may be liable for treble damages (three
times the amount improperly billed) and civil
penalties up to $11,000 per claim
Example: “Double Dipping” Billing a third party for any items or services funded by the study
The National Research Climate: Recent OIG Settlements Including Research Issues
2004 U Wash. $32 million Third party billing practices
2005 Rush $1 million Third party billing practices
(First settlement related to National Coverage Decision on Clinical Trials)
2005 Cornell $4.4 million Inappropriate use of federal funds
Third party billing practices
Effort reporting
2005 UAB $3.4 million Third party billing practices
Effort reporting
2005 Mayo $6.5 million Inappropriate use of federal funds
2006 U Conn. $2.5 million Overstating grant expenses
2008 St. Louis U $1 million Inappropriate use of federal funds
Effort reporting
2008 Yale U $7.6 million Inappropriate transfer of funds
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How well is this process working today?
Metrics: CRRC is monitoring 823 active studies of which 476 (57%) have reported subjects.
62% of the studies with subjects have submitted at least one enrollment outside of the required timeframe.
80% of primary study coordinators are associated with a study with at least one violation.
Approx. 5500 total research
patients monitored.
Groups with CRRC studies Studies w Subjects
Studies w Enrl Violations
% w Enrl Violations
Cancer Center 175 104 59% Neurology 43 32 74% Pulmonary & Critical Care 26 21 81% Pediatrics 32 20 63% Ophthalmology 26 19 73% Dermatology 14 9 64% Cardiology 11 8 73% Hepatology 19 8 42% Gastroenterology 6 6 100% Radiology 6 6 100% Nephrology 10 6 60% Neurosurgery 11 6 55% Medicine 5 5 100% Psychiatry 5 5 100% Infectious Diseases 14 5 36% Clinical Pharmacology 5 4 80% Anesthesiology 6 4 67% Endocrinology 7 4 57% Otolaryngology 7 4 57% Surgery 10 4 40% Diabetes Research Institute 15 4 27% Rehabilitation Medicine 4 3 75% Surgery Transplant 5 3 60% Orthopaedics 2 2 100% Hospital Medicine 3 2 67% Epidemiology 1 1 100% Family Medicine 1 1 100% HIHG 2 1 50% General Internal Medicine 1 0 0% Obstetrics & Gynecology 2 0 0% Urology 2 0 0%
Grand Total 476
Based on active CRRC studies as of 1/14/11. Excludes migrated subject enrollment information.
Velos eResearch UM’s enterprise clinical trials management system for study and subject tracking
Supports Processes for: • Subject consenting & visit tracking • Study management & coordination • Sponsor Invoicing and Milestone
mgmt • DSM & S/AE tracking • Case Report Form data collection
Other Features • Web-based (IE, Firefox, Safari) • Audit tracking capability, enables
21 CFR Pt 11 • Protects subject privacy (HIPAA) • Supports multi-institutional
cooperative trials and community-based research
• Summary & ad hoc reporting; Export to Excel, SAS
• 10 inbound/outbound interfaces with other UM systems
Industry Studies • Track milestones achieved
• Reconcile study financials
• Track visits across multiple studies, sponsor
PI-initiated Studies • Get up and running quickly, no
need to develop unique system
• Collect data in electronic case report forms
• Export data for analysis
• Track subject protocol compliance, calendar deviations, & adverse events
• Manage multiple data collection sites
Research Enablement
From an administrator's standpoint, be able to answer the following questions: • How many of my department’s studies are active/enrolling? • How many active studies have accrued / not accrued a subject?
Velos Interfaces
Pipeline Projects
1- Clinical Coordinator Dashboards (scheduling, CITI certifications, data management elements) 2- Principal Investigator and Administrator Dashboards (Superset of the information the Coordinators Dashboard. It also has financial elements) 3- Clinical Trials Search Engine in the UHealthSystem.com website 4-Enhancements to the interface between Velos and UChart (Epic) 5- Matchmaker Version 1.0
Contacts
Suzanne Liv Page Director 305.243.8596 [email protected] CRIS Website: http://med.miami.edu/cris CRIS & CRRC e-mails: [email protected] [email protected]
Phone Number: 305.243.7704
Sean Rinehart Director 305.243.7035 [email protected] Eric Ponce Senior Project Manager 305.243.1107 [email protected] ORIM Website: http:// med.miami.edu/orim ORIM e-mail: [email protected]
Phone Number: 305.243.2314
