CCTS Lunch & LearnAugust 14th, 2018

Agenda

u Introduction- Meredith Fitz-Gerald

u Research Administration Updates-Jonathan Miller

u IRB Updates- Vanessa Champigny

u CTAO Updates- Mark Marchant

u OSP Updates- Debbie Graves

u CBR Updates- Dawn Matthews

u OnCore Updates- Lisa Williams

u Power Trials Updates- Alicia Martin-Gunter

SAVE THE DATES!

u Next Lunch and Learn: December 11th

u Pediatric Lunch and Learn: August 24th

u Research Seminar : September 6th

u Research Training Program starts September 11th

u Research Orientation: September 27th

CCTS Lunch and Learn

Research Administration Update

Jonathan E. Miller, MPPA, CIPAssistant VP for Research Administration

Operations and SystemsAugust 14, 2018

Office of the Vice President for Research

• UAB Grand ChallengeProjects that unite unique UAB around a single issue of high importance.https://www.uab.edu/plan/grand-challenge

• Nathan Meier, Research Development Director• Starts September 1st

• OIRB Director Update

• IRAP Upgrade – coming Monday, August 27th

IRAP Upgrade – Town Halls

• We will host the following Town Halls to introduce the new features that affect campus users:• Monday, August 20th from 9:30 to 10:30 in West Pavilion

Room E• Tuesday, August 21st from 1:30 to 2:30 in Heritage Hall Room

102• Wednesday, August 22nd from 1 to 2 in Margaret Cameron

Spain Auditorium

• The presentation slides will be posted after the town halls have occurred.

IRAP Upgrade - Training

• 14 sessions in a computer classroom • Two general training sessions• Six training sessions dedicated to IACUC/Lab Animals• Six training sessions dedicated to IRB/Human Subjects

• Register in the UAB Learning System for IRAP V15 Training

Office of the IRB

UAB Office of the IRB

IRAP Friendly Reminders

UAB Office of the IRB – IRAP Friendly Reminders

Don’t forget to hit Submit!

Application initiated = Has not been submitted

UAB Office of the IRB – IRAP Friendly Reminders

IRB Protocol Number • Available as soon as you name the PI in a new

submission.

UAB Office of the IRB – IRAP Friendly Reminders

Successful IRAP Submissions• PI/Delegates receive a Submission Receipt Email• Submission Status indicates “Intake processing initiated”

IRAP Guidance • Available on the IRB Website

UAB Office of the IRB

IRB Training Updates

UAB Office of the IRB – IRB Training Updates

IRB Continuing/Refresher Training• NEW!!! 2018 IRB Refresher Training• Available this week!• Access the course from the OIRB website• CITI – only 2 modules

UAB Office of the IRB

Revised Common Rule

UAB Office of the IRB – Revised Common RuleWhat is the Common Rule???

o The Federal Policy for the Protection of Human SubjectsoRegulations governing human subjects researcho Criteria used by IRBs to review human subjects researcho Last updated in 1991

Revised Common Ruleo “Modernize, strengthen, and make more effective”o Effective: January 21, 2019oProvides time for IRBs to revise forms and practicesoAllows some changes to be implemented early

UAB Office of the IRB – Revised Common Rule

How does the Revised Common Rule affect me???

UAB Office of the IRB – Revised Common Rule

Informed Consent Changeso Concise Summary

o Consent must begin with a “concise and focused presentation of the key information”

oA summary that will help a potential participant understand whether or not to participate in the research

o Table or paragraph formato IRB will develop samples/templates of concise

summaries

UAB Office of the IRB – Revised Common RuleConsent Form Changes

Sample of a Concise Summary

UAB Office of the IRB – Revised Common Rule

Expedited Review

Continuing Review for Expedited Studieso Will no longer be required!!!o There may be some exceptions:

o Conflict of interest, compliance issues, other requirements, etc.

o Keep sending in your Continuing Review submissions!oWe will let you know when to stop!

UAB Office of the IRB – Revised Common Rule

Expedited Review Studies

o Still required to submit amendments and problem reports to the IRB, as necessaryo Must check in every 3 yearso IRB will send you emails annuallyo NEW! Expedited Status Update (ESU)

o The ESU will be a section in the Project Revision/Amendment Form

UAB Office of the IRB – Contact Us

Office of the IRBAB470934-3789irb@uab.edu

Updates on Clinical Trials Initiatives

Mark Marchant, MPH, MBA, CCRPDirector, CTAO

• Electronic Subject Payment System• Utilizes ClinCards• Replaces Visa Debit Cards and Petty Cash• Web Portal for Subject Entry and Visit Keeping• Cards have no value until study visits kept in system• Reporting capabilities

• Phased Roll-out• Test Sites: Lung Health Center & Psychiatry (October 2017)• Wave 1:

• Q1 2018• Anesthesiology; Cell, Developmental & Integrative Biology; Dermatology;

Emergency Medicine; Genetics; OB/GYN; Ophthalmology; Oral & Maxillofacial Surgery; Pathology; Pediatrics

• Wave 2: • Q2 2018• School of Public Health; Medical Education; College of Arts & Sciences

• Wave 3:• Q3/Q4 2018• Dept. of Medicine

• HIPAA Training Requirement for Non-Covered Entities • SSN Requirement Exemption• Cost• Cards: $3.70 paid by University

• Loads: $1.15 paid by University

• Reminder:• Review language in ICF to ensure silent on payment type

Pending Accounts

• Be sure to apply appropriate expenses (fees and faculty/staff salary) to pending accounts upon receipt for industry-sponsored clinical trials.

• Reminders continue monthly with individual orgs.• October 1st: Institutional deadline for full

compliance.

Certification

• National Scope• PI (CPI)

• Better Recruitment/Fewer Queries• www.acrpnet.org/certifications/pi-certification

• Staff (CCRP/CCRC)• Local SoCRA Chapter• Susan Branscum (sbranscum@peds.uab.edu)

QUESTIONS

???

OSP UpdatesDebbie GravesTraining Coordinator – OSP dggraves@uab.edu 205.934.1408

Agenda

• NIH launched new Human Subjects System (HSS) June 9, 2018

• F&A Offset Form eliminated by UAB April 16, 2018

• New form: Federal Grant Outgoing Subaward Form launched February 19, 2018

NIH Human Subjects System (HSS)

• Replaced Inclusion Management System (IMS)

• HSS auto populated by human subjects/clinical trial data

entered in applications submitted 1/25/18 and forward

• Post-submission updates to human subjects/clinical trial

information (human subjects protections, participant &

enrollment information, Clinicaltrials.gov registration and

reporting information) must be made in HSS

• Access HSS through eRA Commons Status page or link in

Research Performance Project Report (RPPR) area of eRA

Commons

• NIH has user guide and three helpful video tutorials on their

training page: https://era.nih.gov/hss_training.htm

F&A Offset Form eliminated

• Only other option: Cost sharing • Must be approved by PI’s dean and chair (signature

required on cost sharing commitment form submitted to OSP)

Federal Grant Outgoing Subaward Form

OSP Trainingopportunities

OSP: 205.934.5466dggraves@uab.edu

205.934.1408

CLINICAL BILLING REVIEW (CBR) UPDATES

Dawn Matthews, MPA, CCRC, CPC, CNMManager, Clinical Billing Review

CBR ANNUAL DEPARTMENTAL MEETINGS

u Beginning in September, CBR will begin meeting with each submitting department annually.

u It is an opportunity to connect the CBR Analyst with the departments they support.

u Our meeting will provide specific information catered to each department.

u Reminders, updates and any new information will be provided during these meetings.

u If you submit to CBR, please expect to receive a meeting request from your assigned CBR Analyst. We anticipate these meetings to last about an hour.

Questions?

General Email: fap@uab.edu

OnCore Enterprise Update

Lisa Williams MSHIOnCore Enterprise Administrator

14 AUG 2018

Project Updates

• Timeline• Financials Project• User Reminders

Enterprise Roll Out• OnCore expansion is almost complete.

• Congratulations to Departments in Waves 1 and 2. Well Done!

• SiteMinder will be shut down after Sept. 30th, 2018.• Data will be archived.

Wave 1DOM

Dec. 2017

Wave 27 Depts.

April 2018

Wave 317 Depts.

and Schools September

2018

Financials1st Quarter of

2019

SiteMinder

Wave 3 ParticipantsSchool of Medicine School of Health ProfessionsAnesthesiology Nutrition SciencesCell, Development & Integrative Biology Physical Therapy

Dermatology Public Health/Health BehaviorEmergency MedicineGenetics School of OptometryOB/GYN; URO/GYN OptometryOphthalmologyOrthopaedic Surgery College of Arts and SciencesPathology PsychologyPediatricsPhys. Medicine & Rehabilitation School of Dentistry

Oral & Maxillofacial Surgery

Timeline

Aug13-17 Super User

Training

Aug 17 Final Copy

of SiteMinder

Data prepared

for migration

Sept 7Last Day

to keep SiteMinder visits; for

CTBNs

Sept 8-9Data

Migration

Sept 10 Validation

Week begins

Sept 17Go-Live Week begins

Q1 2019 OnCore

V15 upgrade

Q1 2019 Financials

Go-Live

Wave 3Wave 3 Wave 3 Wave 3 Wave 3Wave 3 2019 2019

OnCore Financial Project• Financials Working Group established• Includes financial personnel from a variety of research teams,

billing offices, OnCore Trainers, and Team members

• Tasked with identifying and introducing best practices for budgeting and invoicing within OnCore

• Weekly working calls with Forte to parse out each step in the financial process; define needs of the study teams and the institution

• Future Validation sessions will test and modify new processes

• Creation of Universal Charge Master is in development

OnCore User RemindersCalendar Release Buttons Ownership

“Complete” - Calendar BuildersCalendar has been validated by study team

“Finance Signoff” - Study Coordinator Verify bill-to designations, all items are reflected in calendar. Definition to be refined with FIN go-live.

“Release” - Study Coordinator Ready to occur subject visits

“New Version” - STOP! Calendar Builders Only

OnCore User Reminders

Re-Validate your protocol calendars checking for accuracy of visit procedures and bill-to designations.

“Occur” visits within 24-48 hours of actual visit. This decreases chance of subjects being billed for study services.

Double Check your Calendar

Visit Tracking Window

OnCore User Reminders

Dates must flow logically.

1) IRB Approval 2) Consent Signed

3) Eligibility 4) On Study

5) IRB Expiration

Logical Date Order Find ALL Study Subjects

OnCore Support- Calling for “HELP!”

1. Super Users2. Help Desk 4-8888• A ticket is created and routed (emailed) to OnCore

Support if not handled by Help Desk Support staff.• Calling the Help Desk provides a timely response to

your issue when OnCore team is not available.

3. OnCore@uabmc.edu

Questions?

From the OnCore Enterprise Team

OnCore@uabmc.edu

PowerTrials: Quick Overview and Updates

CCTS Lunch & Learn

August 14, 2018

Project Overview

Build & Test Research

PowerPlans

OnCore

PowerChart1. Banner Bar2. 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

No Banner Bar indicator for patients On Follow Up!!

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

PowerTrials Updates

§ New PowerTrials website!o Updates! o Resources!

ü IMPACT Research Coordinator Resource Manual: Research PowerPlan Ordering

ü PowerTrials PowerPlanPresentation

ü PowerTrials Quick Tips and Tricks

ü PowerTrials Process

o FAQs!

§ http://www.uab.edu/medicine/ctao/investigators/powertrials

PowerTrials Updates

§ ER Admission Automated Notification! o As of 5/24/18, the Study Team listed in OnCore (Principal Investigator and

Research Coordinator) will receive a Message, in the Impact PowerChart Message Center, when a patient that is listed as enrolled in the study is admitted to the Emergency Room.

PowerTrials Future State

§ Adding additional orderables (Echos, ECG, PFTs, Dexascans, Research Pharmacy, etc.)!

§ Wave 2 departments!

Things to Remember

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

§ Your licensure will determine whether or not you have the privileges to place orders and/or PowerTrials PowerPlans.

Help!

• Banner Bar: patient does not have Research On Study indicator

s Check to make sure patient is not On Follow Up in OnCore. Only patients On Treatment will have the indicator.

s Check and make sure your patient has a Sequence No. in OnCore.

• Research Summary

s Make sure the Research Summary is in PDF format and has the OnCore Protocol No. in the title

• PowerPlan Orderables

s Submit a request for further review to powertrials@uabmc.edu

• For PowerTrials help, email powertrials@uabmc.edu

Questions

§ Questions?

§ For further questions or concerns:

Alicia GunterPowerTrials Administrator (HSIS)

(205) 996 - 8763 office abmartin@uabmc.edu