ccts lunch and learn - uabnew! uab single irb guidance • all other scenarios will be referred to...
TRANSCRIPT
CCTS Lunch and Learn December 19, 2017
Agenda
Introduction – Penny Jester IRB Update - Vanessa Champigny CTAO Update – Mark Marchant CBR Update – Dawn Matthews OnCore Update - Lisa Williams/John Sandefur Powertrials Update – Alicia Martin–Gunter/Brian Bates
Upcoming Education Opportunities (2018)
• Jan 1 – Round table discussion: what your budget challenges
• Jan 11 – At Risk Accounts: using them successfully • Jan 23 – ClinicalTrials.gov: Results reporting Workshop • Jan 25 – Research Orientation Program • Feb 1 – Internal Quality Control: measuring, assessing and
correcting (repeat) • Feb 6 – Round table discussion (TBA) MAY: Research Training Program
Single IRB
Why Do We Need a Single IRB?
• NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
• Effective date: January 25, 2018
• Revised Common Rule • Effective date: January 19, 2018 for overall rule;
January 20, 2020 (for §__.114(b) that concerns single IRB
Definitions
• Single IRB/Central IRB • One IRB performs regulatory review for multiple participating sites
Definitions
• Reviewing IRB • The IRB of record for the research; the Lead IRB
• Performs regulatory review of the project for all relying sites. » When other sites rely on the UAB IRB for research
oversight, the UAB IRB is considered the reviewing IRB/the IRB of record.
• Relying Site • Institution that cedes the responsibility of regulatory review of the research
» When the UAB IRB relies on another IRB for research oversight, we are considered the Relying Site.
Definitions
• IRB Authorization Agreement (IAA) / Reliance Agreement
• Allows for reliance on another institution’s IRB • Different models for reliance:
• Individual study • Consortium/cooperative group • Online Master Reliance Agreements
• SMART IRB • SMART IRB Exchange • IRBchoice
New! UAB Single IRB Guidance
• UAB IRB will agree to serve as the single IRB in the following scenarios: • Legacy arrangements where the UAB IRB already serves as the
single IRB. • When the sponsor requires the prime awardee institution’s IRB to
serve as the single IRB • Other extenuating circumstances considered on a case by case
basis. The complexity of the protocol and the number of sites will factor into this decision.
New! UAB Single IRB Guidance
• All other scenarios will be referred to • an independent IRB (e.g., Quorum, Schulman, WIRB), or • a Trial Innovation Network (TIN) central IRB, when
applicable • Because UAB is a Clinical & Translational Science Award (CTSA) institution and part
of the CTSA’s Trial Innovation Network, the use of the Trial Innovation Network Central IRBs (Johns Hopkins University School of Medicine, the University of Utah, or Vanderbilt University Medical Center) may be available for studies. Additional information on use of the TIN Central IRB is accessible on the TIN website.
New! UAB Single IRB Guidance
UAB is Prime • Sponsor requires a single IRB
• UAB is responsible for arranging single IRB review • UAB IRB • Independent IRBs • Trial Innovation Network (TIN) Central IRB
UAB is a Participating Site • Main site is responsible for arranging the single IRB review,
reliance mechanism, and costs
Costs of Single IRB Review
• Fees for single IRB review • Responsibility of the PI of lead site to incorporate costs for single IRB review in
budget.
• Fees for UAB IRB as single IRB • Fees will be charged for non-UAB sites that rely on the UAB IRB. Additional
information from OSP is forthcoming.
IRB Website
Updates on Initiatives Mark Marchant, MPH, MBA, CCRP
Director, CTAO
• Electronic Subject Payment System • Utilizes ClinCards • Replaces Checks, Visa Debit Cards, Petty Cash • Web Portal for Subject Entry and Visit Keeping • Cards have no value until study visits kept in system • Reporting capabilities
• Test Sites • Lung Health Center & Psychiatry • Completed TEST environment in August • Started PROD environment in October
• Phased Roll-out • Starts in Q1 2018 • Wave 1: Anesthesiology; Cell, Developmental & Integrative Biology;
Dermatology; Emergency Medicine; Genetics; OB/GYN; Ophthalmology; Oral & Maxillofacial Surgery; Pathology; Pediatrics
At-Risk Accounts
• January 2017: All sites submitting an industry-sponsored clinical trial to OSP are provided an At-Risk Account.
• Why is this important? • At-Risk Accounts allow sites the ability to assign and track costs
associated with study start-up in real time which makes admin oversight of trials easier.
At-Risk Accounts
• I have the account, now what? • Start applying the expenses you incur throughout study start-up
including fees and effort. • Account back-dated 1 year prior to submission to OSP to enable
the effort utilized to create that submission and others (such as IRB or CBR) to be applied to the account.
At-Risk Accounts
• Won’t it create a deficit? • Yes at least temporarily, but more importantly it helps you to
understand the cost of conducting that trial from start to finish by allocating the costs as they occur.
• As your understanding of cost allocation grows during the trial conduction lifecycle, you can use that information to leverage nonrefundable start-up payments from Sponsors to offset the expenses.
QUESTIONS
???
CBR Update
Dawn Matthews Bryant December 19, 2017
OnCore Enterprise Update CCTS Lunch and Learn 12/19/2017
John Sandefur MBA, MSHI, IT Project Manager IV-Enterprise Lisa Williams MSHI, OnCore Enterprise Administrator
• Benefits for Research Teams: A Review • Now that We are Live:
• System Walk-through • What to Expect
• Project Next Steps
Project Update
• Provide a central application to track protocol activity from study start-up to closeout
ü Task Lists • Enhance regulatory compliance
ü Renewal Reminders ; subject reconsent reminder
• Improve communication and efficiencies
ü Notifications; view information • Improve billing compliance (Power Trials)
• Provide for accurate and consistent budgets • Track sponsor invoicing & payments • Provide self-service reporting capabilities
OnCore – How You Can Benefit
OnCore: Protocol Initiation
OnCore: Budget Development
OnCore: Coverage Analysis
OnCore: Study Calendar Development
OnCore: Record IRB Approval
OnCore: Record Signoffs
Transfer Protocol Data to Cerner/ PowerTrials
OnCore: Subject Consent
OnCore: Subject on Study
OnCore: Subject Accrual
Cerner: Patient/Subject On Study
Cerner: PowerTrials Study Information
Phase 1 Go-Live DEC 14, 2017
Phase 2 Go-Live JAN 19, 2018
Cardiology GI/HEP
Endocrinology Gen. Internal Medicine
Infectious Diseases - HIV Geriatrics
Infectious Diseases - STI Nephrology-Transplant
Infectious Diseases– CTG (Clinical Trials Group)
Nephrology – CTG (Clinical Trials Group) Preventive Medicine
Pulmonology
Rheumatology
Wave 1 Phases by Management GroupDepartment of Medicine
Waves 2 and 3 Tentative Grouping
WAVE 2 (April 2018)
Neurology Otolaryngology (OTOL) Radiology Neurosurgery Psychiatry Urology Surgery Phys. Med. & Rehabilitation
WAVE 3 (September 2018)
Anesthesiology Cell Dev. & IB (Exercise Medicine) Dermatology Emergency Medicine Genetics
OB/GYN (Maternal Fetal) OB/GYN (Reproductive) OB/GYN (Uro/Gyn) Ophthalmology Ora l & Maxillofacial Surgery Pathology Pediatrics
* Indicates departments that have confirmed participation
Training by CRSP
§ End user training for Wave 1 began October 18th and ran through December 8th. Training will resume on January 2nd. Earlier training focused on phase 1 of Wave 1 and later training will focus on phase 2.
§ 53 attendees for OnCore Overview presentations § 103 attendees for OnCore Protocol training
§ 78 attendees for OnCore Calendars training
§ 82 attendees for OnCore Subject Management training
§ OnCore training for each implementation wave begins approximately six weeks prior to implementation.
§ The trainers will continue to add classes on various topics such as effort reporting, financials, etc.
• Schedule an organizational meeting with the Project Manager.
• Name your super users. • Compile a list of OnCore users and others
who are associated with trials and need to be in OnCore.
• Identify what training is required for each OnCore user.
• Review the list of trials in SiteMinder and update data and close studies as appropriate.
• Key staff will attend regular meetings with the project team and others who will go-live in your Wave.
• Study the documentation that will be provided and prepare!
What to Expect Prior to Go-Live
• Prior to go-live, migrated data from SiteMinder must be validated over a period of several days. • IRB approval dates, on study dates and other
data must be entered • Calendars must be reviewed and released. • Data entered or changed in SiteMinder since
the cutoff date for migration must be entered in OnCore (reports are provided).
• During validation, you will submit CTBNs by fax to the billing offices.
• After go-live, you will check in (keep) visits in OnCore.
• SiteMinder will only be used for studies that did not migrate to OnCore (studies with a short time until closure).
What to Expect When You Go Live
OnCore Support Model
• First-line of support will be departmental super users during go-live.
• The HSIS Help Desk will be the primary point of contact for post go-live support going forward.
• A command center in HSIS will be operational for two weeks during go live events.
• OnCore documentation may be found at http://www.uab.edu/medicine/ctao/investigators/oncore-enterprise/training.
Questions?
PowerTrials Overview for New Orderables
A Product of Cerner Impact
Project Overview
Build & Test Research
PowerPlans
OnCore
PowerChart
1. Banner Bar
2. Research Summary
Cerner IMPACT
PowerTrials
Research study built in OnCore
Patient placed “on study” in banner bar, linked to research summary
Responsible: OnCore
Responsible: Clinical Trials Admin Office (CTAO)/HSIS
PowerPlan built with the orderables required by the study
Responsible: HSIS
Sample Research Summary
Ordering the PowerPlan
• The Research Coordinator will Add the PowerPlan to the patient’s encounter when a patient has consented for the study, using the UAB protocol number.
PowerPlan Display
• All of the study required cycles that contain Lab and Rad orders will display on the patient’s chart. • The Research Coordinator will ‘Initiate’ the Cycle that applies when the patient comes in for the required
visit.
IRB number: billed to the Clinical Trial
Q1: billed to the patient’s insurance as Standard of Care
Completed
Things to Remember
• Until 100% implementation is completed, some orders will continue to go through the original process (green sheet, order through Impact, etc.)
Questions
• Questions? • For further questions or concerns:
Alicia Gunter PowerTrials Administrator (HSIS)
(205) 996 - 8763 office [email protected]
Next CCTS Lunch and Learn!
March 2018