CCTS Lunch and Learn. December 19, 2017

Transcription

1 CCTS Lunch and Learn December 19, 2017

2 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

3 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

4 Single IRB

5 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

6 Definitions Single IRB/Central IRB One IRB performs regulatory review for multiple participating sites

7 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.

8 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

9 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.

10 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.

11 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

12 Fees for single IRB review Costs of 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.

13 IRB Website

14 Contact Information Office of the IRB AB

15 Updates on Initiatives Mark Marchant, MPH, MBA, CCRP Director, CTAO

16 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

17 Test Sites Lung Health Center & Psychiatry Completed TEST environment in August Started PROD environment in October Phased Roll-out Starts in Q Wave 1: Anesthesiology; Cell, Developmental & Integrative Biology; Dermatology; Emergency Medicine; Genetics; OB/GYN; Ophthalmology; Oral & Maxillofacial Surgery; Pathology; Pediatrics

18 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.

19 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.

20 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.

21 QUESTIONS???

22 CBR Update Dawn Matthews Bryant December 19, 2017

23 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

24 Project Update Benefits for Research Teams: A Review Now that We are Live: System Walk-through What to Expect Project Next Steps

25 OnCore How You Can Benefit 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

26 OnCore: Protocol Initiation

27 OnCore: Budget Development

28 OnCore: Coverage Analysis

29 OnCore: Study Calendar Development

30 OnCore: Record IRB Approval

31 OnCore: Record Signoffs

32 Transfer Protocol Data to Cerner/ PowerTrials

33 OnCore: Subject Consent

34 OnCore: Subject on Study

35 OnCore: Subject Accrual

36 Cerner: Patient/Subject On Study

37 Cerner: PowerTrials Study Information

38 Wave 1 Phases by Management Group Phase 1 Go-Live DEC 14, 2017 Cardiology Endocrinology Infectious Diseases - HIV Infectious Diseases - STI Infectious Diseases CTG (Clinical Trials Group) Department of Medicine Phase 2 Go-Live JAN 19, 2018 GI/HEP Gen. Internal Medicine Geriatrics Nephrology-Transplant Nephrology CTG (Clinical Trials Group) Preventive Medicine Pulmonology Rheumatology

39 Waves 2 and 3 Tentative Grouping WAVE 2 (April 2018) WAVE 3 (September 2018) Neurology Otolaryngology (OTOL) Radiology Neurosurgery Psychiatry Urology Surgery Phys. Med. & Rehabilitation * Indicates departments that have confirmed participation 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

40 Training by CRSP End user training for Wave 1 began October 18th and ran through December 8th. Training will resume on January 2 nd. Earlier training focused on phase 1 of Wave 1 and later training will focus on phase 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.

41 What to Expect Prior to Go-Live 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.

42 What to Expect When You 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.

43 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 oncore-enterprise/training.

44 Questions?

45 PowerTrials Overview for New Orderables A Product of Cerner Impact

46 Project Overview OnCore Cerner IMPACT PowerTrials Research study built in OnCore Responsible: OnCore PowerChart 1. Banner Bar 2. Research Summary Patient placed on study in banner bar, linked to research summary Responsible: Clinical Trials Admin Office (CTAO)/ HSIS Build & Test Research PowerPlans PowerPlan built with the orderables required by the study Responsible: HSIS

47 Sample Research Summary

48 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.

49 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. Q1: billed to the patient s insurance as Standard of Care IRB number: billed to the Clinical Trial

50 Completed

51 Things to Remember Until 100% implementation is completed, some orders will continue to go through the original process (green sheet, order through Impact, etc.)

52 Questions Questions? For further questions or concerns: Alicia Gunter PowerTrials Administrator (HSIS) (205) office

53 Next CCTS Lunch and Learn! March 2018