CCTS Lunch & Learn · • February 20: Recruitment and Retention/i2b2, Research Match, Social Media...

205.934.7442 [email protected] www.uab.edu/ccts @cctsnetworkThe Center for Clinical & Translational ScienceCENTER FOR CLINICAL & TRANSLATIONAL SCIENCE

AUBURN UNIVERSITY | HUDSONALPHA INSTITUTE FOR BIOTECHNOLOGY | LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER | PENNINGTON BIOMEDICAL RESEARCH CENTER | SOUTHERN RESEARCH TULANE UNIVERSITY | TUSKEGEE UNIVERSITY | UNIVERSITY OF ALABAMA | UNIVERSITY OF ALABAMA AT BIRMINGHAM | UNIVERSITY OF MISSISSIPPI MEDICAL CENTER | UNIVERSITY OF SOUTH ALABAMA

CCTS Lunch & LearnDecember 10, 2019

AgendaIntroduction/Welcome/Upcoming Events- Meredith Fitz-Gerald OSP- Debbie GravesIRB- Christina BlackmonResearch Administration – Matt RonningJob Ladder - Mark Marchant Operating Accounts – Samone AlexanderPharmacy Updates- Christopher ChapleauOnCore- John Sandefuri2b2- Matt WyattSpecimen Processing – Jennifer Okunbor

SAVE THE DATESResearch Orientation Program: January 30, 2020 and March 19, 2020Special Topics in Clinical Research/Research Seminar Series: • January 9: IRB Updates with Adam McClintock• January 23: ClinicalTrials.gov with Denise McKenzie• February 6: IRB Updates with Cari Oliver and Dorothy Shaw• February 20: Recruitment and Retention/i2b2, Research Match, Social Media with Mark

Marchant and Matt Wyatt• March 5: Budget Workshop with Mark Marchant and Meredith Fitz-Gerald

Next Lunch and Learn: April 14, 2020

SAVE THE DATES

Upcoming OnCore training:December 17, 2019January 21, 2020February 25, 2020CITP: Coming Spring 2020Research Training Program: April 7, 2020Questions on training, please email: [email protected]

How to Gain Access:

Monitor Access to EHR:

https://www.uab.edu/medicine/ctao/investigators/monitor-access-to-ehr

OnCore Information:https://www.uab.edu/ccts/research-commons/oncore/resources

OnCore Access: https://www.uab.edu/medicine/ctao/images/OnCore_ID_Request_Form_V4_10.pdf

PowerTrials: [email protected]: Alicia Martin-Gunter [email protected]

https://www.uab.edu/medicine/ctao/investigators/monitor-access-to-ehr

https://www.uab.edu/medicine/ctao/images/OnCore_ID_Request_Form_V4_10.pdf

mailto:[email protected]


Clinical Trials Kiosk

Answers to your clinical trial questions? Look to the Clinical Trials Kiosk for tips and tools for research teams. This one-stop shop will continue expanding with the resources you need.

https://www.uab.edu/ccts/clinical-translation/clinical-trial-lifecycle/?utm_source=golink&utm_medium=golink

http://click.reach.uab.edu/?qs=92659e9c0dd028b713dd1bbc0c5079368d989559394cd7000967fbc93ca80901a0248bff04b886e79f5315719fe812f6a68824611714d2fa

https://www.uab.edu/ccts/clinical-translation/clinical-trial-lifecycle/?utm_source=golink&utm_medium=golink



OSP Updates

Debbie GravesOSP Training Coordinator

[email protected] (205) 934-1408


OSP/RBO Updates

• Proposal Submission Requirements changing January 1, 2020• New UAB Internal Federal Budget form for processing awards (replaces PHS 398)• Research Matters replacing Research Digest• Upcoming Research Administration Forum (RAF)

• Proposal Submission Requirements changing January 1, 2020

• Final Proposals (research plan draft included) in a Complete Submission due to OSP no later than 8:00 AM five (5) full business days prior to the sponsor deadline

• “Ready-to-Submit" Proposals due to OSP no later than 12:00 noon business day before sponsor deadline

• Email confirmation must be sent to OSP Officer stating final proposal is “Ready For Submission”

• For NIH submissions, email should include screenshot stating “All Validations Passed” from NIH ASSIST


• PIs submitting to NIH required to review application image in NIH ASSIST Preview Application screen and make any required changes before submission to OSP

• NIH Changed/Corrected proposals will be limited to technical and system-related issues only

• Due to volume, OSP may not be able to resubmit grant application due to PI desired changes that should have been caught by the PI/department during preview process


• In rare instances, will be exception process• PI must submit letter request, signed by PI, Department Chair and Dean, to

Vice President for Research (VPR) detailing mitigating circumstances [email protected]

• No delegate or per signatures accepted • If approved by VPR, approval should be included in OSP submission• Exceptions after 12:00 Noon the day before sponsor deadline will not be

considered

• New UAB Internal Federal Budget form for processing awards (replaces PHS 398)

• New form developed to expedite processing of awards• Submit to OSP upon receipt of Request for Award documents form• Form for internal use only – does not replace sponsor-required budget

templates• Mandatory beginning January 1, 2020

• Research Matters to replace Research Digest

• New email newsletter to replace Research Digest• Formatted in Marketing Cloud platform• Scheduled to go live January 5, 2020• Will begin publishing publicity requests last week of December

Mark your calendar: Next Research Administration Forum (RAF) coming up January 22



IRB Updates & Current Events

Christina Blackmon, MPA | Education & Outreach Specialist

CCTS Lunch & Learn

Office of the Institutional Review Board

What is happening the IRB office?

• Update on IRB Staff Positions• Office Services Specialist – Malik Thomas• Operations & Systems Analyst – Andrew Atchison• Educational & Outreach Specialist – Christina Blackmon

• Electronic Resources• Evaluation of Metrics & Baseline Data• AAHRPP Reaccreditation• Single IRB

Welcome:

Matt RonningAssistant Vice President, Research Integrity OfficerUAB | The University of Alabama at Birmingham

P: 205.975.5063 | [email protected]




Updates on Clinical Trials Initiatives

Mark Marchant, MPH, MBA, CCRPDirector

Clinical Trials Administrative Office

Career Ladder

• Pilot• O’Neal Comprehensive Cancer Center• February-April

• Phase I• Anesthesia, Civitan, CRSP, Dermatology, Emergency Medicine, Exercise Medicine, ICOS, Radiology• June/July

• Phase II• Neurosurgery, OB/GYN, Ophthalmology, Orthopaedic Surgery, Otolaryngology, Pediatrics,

Psychiatry, Rad/Onc, Surgery, Urology• July/August

Career Ladder

• Phase III• Arts & Sciences, Health Professions, Public Health, Optometry, Dentistry• August/September

• Phase IV• Department of Medicine• September/October

• Phase V• Genetics, Neurology, Pathology, Nursing• October/November/December

Career Ladder

• Phase VI (Catch-up)• Any staff missed (new hires, transfers, etc.)• November/December/January

• Go-Live• Early 2020• Discussions with Departmental leaders to review proposed titles and Job Descriptions

in coming weeks• Beyond Implementation

• Certification

Greenphire

• Pilot: Fall 2017• Waves 1 & 2: 2018• Wave 3: Q1/2 2019• Wave 4: Q3 2019• Wave 5: Q4 2019

• Civitan, CCC, Orthopaedic Surgery, Physical Medicine, Radiation Oncology, Dentistry, Nursing, Health Professions

• Reminder: Discontinuation of Petty Cash and Pre-Paid Visa Cards

Research Summaries

• 1 page summary for treating physicians at point of care for participants in trials• Created using standard template and emailed to [email protected]• Monthly report provided listing outstanding trials (5%)• Must update OnCore if trial status changes to reflect in PowerTrials


Pending Accounts

• Initiated in January 2017 for industry-funded clinical trials• Monthly reports to Award Managers of current accounts• Expenses (especially effort) should be applied within 45 days of creation, unless

using an Operating Account • Going forward, contracts will be held by OSP until appropriate expenses applied

Clinical Trial Operating Accounts

Samone M. Alexander, MBADirector of FinanceSchool of Medicine

What is a Clinical Trial Operating Account (CTOA)?– Allows research units/areas an option to source salary and operating expenses to

one account and move the salary and operating expenses to the appropriate grant account no less frequently than on a quarterly (March, June, September, and December) basis.

Do I need one?– Depends upon the clinical operation in your unit/area. If you elect not to use this

account, assurances should be made such that all expenses and salaries are appropriately charged.

How do I get one?

SOM website www.uab.edu/somadminClick Finance

Click Clinical Trial Operating AccountsClinical Operating Account Request ProcessSOM Clinical Operating Request FormClinical Trial Operating Account Best Practices

Clinical Operating Account Test in LMS

Next Steps:

SOM will begin reviews of Clinical Trial Operating Accountsin 2020.

Educational sessions on reconciliation (sign up via Doodle)

https://doodle.com/poll/t9qumpm6buatnmh6

Wednesday, January 15 (9:00-10:00 AM)

Wednesday, January 29 (2:00-3:00 PM)

FOT 12 Large Conference Room

• Stay informed– Sign up for SOM biweekly newsletter by sending your email

address to [email protected]• Coming soon

– Process document with detailed step by step reconciliation of a Clinical Trial Operating Account



Pharmacy Updates

Christopher ChapleauManager, UAB Pharmacy Services



OnCore:Managing Visits, Subject Status

and Calendar ValidationJohn Sandefur, MBA, MSHI

Manager II-Application ArchitectOnCore Team Leader

What study visits must be managed in OnCore?

• If a study is in OnCore, ALL visits for that study must be occurred - i.e. both visits that have clinical billables AND those that do not have clinical billables.

• When using OnCore Financials, your financial team will depend on this activity to properly track invoiceable items.

Calendar validation is an important step

• Review the drafted OnCore calendar thoroughly and validate as soon as possible after being notified by OCS.

• Pay careful attention to clinical billable procedures that will appear on the CTBN. Confirm the procedure occurs at the correct visits and has the correct billing designation (S = Standard of Care/bill to patient; X = bill to study).

• Not validating in a timely manner delays the PowerTrials process for building your study’s PowerPlan and delays the ability of your budget team to enter the budget in OnCore when using OnCore Financials.

• Not validating thoroughly can lead to billing errors and corrections that involves additional work from your study team, the billing office, and the OnCore team.

• Contact [email protected] with questions.


What goes wrong with subject visits?

• Occurring a visit in OnCore that has clinical billable items (that have been FAP-approved and linked to the Charge Master by OCS) generates a Clinical Trials Billing Notice (CTBN).

• If subjects are not taken off study or off treatment in OnCore and their subsequent visits are not Occurred, the visits remain in a status of Planned.

• If a visit is submitted by pressing the Submit and Close button and the radio button for Occurred is not chosen, the visit remains in a status of Marked as Planned.

What happens when visits aren’t occurred properly?

• It is important to recognize that CTBNs do not generate charges – they inform the billing offices what was planned and which accounts should receive the charges – the patient or the research account.

• If visits are still in the Planned state, it may be that the subject status needs to be changed or it may be that the visits took place but were not occurred in OnCore. A CTBN will not drop, so if charges drop from the Health System, they may be charged to the wrong payer – e.g. billed to the patient’s insurance instead of to the study account.

• If visits are still Marked as Planned, it is likely that a CTBN should have dropped but did not since the visit was not marked as Occurred. Again, it is possible that charges may be billed incorrectly and mostly likely charged to the patient’s account.

What happens when visits aren’t occurred properly?

• Timeliness of Occurring visits is of utmost importance. To avoid issues with billing compliance, visits must be occurred within 24-48 hours. If a visit is not marked as “Occurred”, a CTBN is not generated for use by the billing office. Without this timely CTBN, there is a risk that charges will be billed incorrectly (e.g. billed to the patient’s insurance instead of to the study account).

• When charges are billed incorrectly, we face compliance and financial risk. If/when charges are denied by insurance, the Health System may have to write them off.

What is the magnitude of this problem?

• Hundreds of visits were Planned and never Occurred over the last year.• Hundreds more were left in the status of Marked as Planned.• It is MUCH more difficult to correct problems after the date of the visit!• The OnCore Administrators are working with study teams to correct these

problems. The number of outstanding visits with issues has decreased by half in the last 3 months.

Occurring visits correctly is vital for accurate billing

• If a procedure is not part of the calendar and needs to be added to a visit, contact the OnCore Team ([email protected]) to assist in selecting the correct Additional Procedure.

• If the correct Charge Master item is not added, it will result in a billing error requiring extra work by BOTH the billing office and the study coordinator.

Subject status is important!

• When subjects are registered to a trial in OnCore, information is sent to IMPACT and the ON STUDY message is displayed in the banner bar of the subject’s chart. If subjects are not registered promptly or taken off study in a timely fashion, the banner bar information will be inaccurate and might affect patient care.

• As stated previously, subject status may also affect billing reports. Make sure that status changes are timely and accurate.

Subject status is important!

QUESTIONS?

• Call the Help Desk at 4-8888

• Email [email protected]




Clinical Data & Tools to Support Research

Matt Wyatt

i2b2, ACT and the Enterprise Data Warehouse

Director of Clinical Research InformaticsCenter for Clinical and Translational Science

UAB Informatics InstituteHealth System Enterprise Data Warehouse

[email protected]

How to Get Data and/or Help?

EDW Analysts

Researcher

What you can Ask?

What you can get!

Current i2b2 Content

Distinct Patients 1,149,663 Distinct Encounters 15,173,213

Distinct Observations/Facts 1,443,811,807

• US Area Deprivation Index– National Percentiles– State Deciles

• US Census - American Community Survey– Educational Attainment (S1501)– Employment, Health Insurance, Income,

Poverty (DP03)– General Housing Characteristics (DP04)– Selected Social Characteristics (DP02)

• The Food Access Research Atlas• CCTS Special Populations

– Medically Underserved Areas in Alabama– Medically Underserved Populations in Alabama– Minority– Rural Counties

2019 Additions to i2b2 Data Domains

• PROM – Patient Reported Outcome Measures ‘• Biospecimens

– UAB Tissues Collection and Banking Facility linkage with clinical data (no longer anonymous)

– UAB Anatomic Pathology– Louisiana Consortium Biobank

• Alamama Genomic Health Initiative– eCRF – Study participant and family history– Genomic Sequencing – Variant Annotation

• Standardized Assessments – Braden, Glasgow, Morse, – Alabama Brief Cognitive Score

• Vitals (HR, RR, O2)

• Data from ~40 CTSA sites nationally• Real Time query for Pt. Counts (similar to i2b2)• The Network provides access to data aggregated from the

electronic health records of more than 100 million patients. • Developed by (NIH-NCATS) through its Clinical and

Translational Science Award (CTSA) program, • Enables researchers to explore and validate cohort

feasibility and identify potential partners for clinical studies

Accrual to Clinical Trials (ACT) Network

https://ncats.nih.gov/

https://ncats.nih.gov/ctsa

More Information – Who to call

[email protected] or Google “UAB i2b2”Informatics Services

– http://www.uab.edu/ccts/research-commons/informaticsEDW data requests

– http://www.uab.edu/ccts/researchcommons/research-data-requestsInformation about i2b2

– http://www.uab.edu/ccts/research-commons/informatics/i2b2i2b2 login URL: https://i2b2-uab.hs.uab.eduACT login: contact [email protected]


https://i2b2-uab.hs.uab.edu/



CCTS Specimen Processing LAB

Jennifer Okunbor, BSResearcher II

Specimen Processing Lab and OnCore Usage

Get Your Patients In OnCore PRIOR to specimen delivery to the lab• OnCore Enterprise Studies • OnCore Cancer Center Studies

This is NECESSARY in order for us to properly assign specimens to your participant record and to print labels

• Label printing MUST occur before samples can be stored

Importance of OnCore Calendar Release

If you are using OnCore to manage your study and asking the CCTS to handle your specimens:• Please ensure that current calendar versions are Released and let us know.

o This is required in order for the lab to have a current and accurate “collection configurations” in OnCore that is linked to the participant visit

Importance of Timely Communication

• It is important to respond to communications.• If you do not know or are unsure of something, ask us!

• Are there updates/changes to your protocol?• Have you informed all pertinent personnel?• Are there changes to the laboratory manual?• Important processing changes

• Changes to study personnel?• New coordinators

Timely Specimen Processing and Storage

• Lab Results are only as good as the condition of the specimens• Proper and timely handling and processing facilitates quality specimen management,

which is required for accurate testing.

• Timely Specimen Processing and Storage depends on:• Completed and released OnCore Calendar Configuration• Preparation of specimen kits and labels that accurately reflect visit details• Prompt Specimen Delivery and Handling

Contacts for Follow Up Questions

• Lab Managers of CCTS - SPAN• Maitlyn Eady (Jefferson Tower 1515) – 4-7967/[email protected]• Jing Wu (230 Shelby Building) – 4-4938/[email protected]

• Director of CCTS - SPAN• Dr. Jeffrey Edberg – 4-0894/[email protected]

• CCTS SPAN Lab Website• https://www.uab.edu/ccts/clinical-translation/clinical-services/specimen-processing-and-

biorepository-unit




https://www.uab.edu/ccts/clinical-translation/clinical-services/specimen-processing-and-biorepository-unit

Questions & Discussion

Next Lunch and Learn: April 14, 2020

CCTS Lunch & Learn · • February 20: Recruitment and Retention/i2b2, Research Match, Social Media...

Documents

Transcript of CCTS Lunch & Learn · • February 20: Recruitment and Retention/i2b2, Research Match, Social Media...