2. 2
Approval Flow Improvements – status
Item Current Update
No level 1 approver
exists
Requisitions and invoices
require manual
intervention
Requisitions now move to and
invoices will move to the next level
approver
Level 1 approver is the
same as the requisitioner
Requisitions require
manual intervention
Requisitions now move to the next
level approver
More than one approval
required
Approvals required more
than once if the same
person approves both
levels
System will validate that the same
person approves at the upper level,
and release the requisition or
invoice – completed for requisitions
Timeout Requisitions take several
days to time out. Invoices
do not escalate
Requisitions will time out sooner
Invoices will escalate to the next
level approver
Changes to the requisition and invoice approval flows:
• Requisition approval updates were programmed, went through extensive user
acceptance testing of 40+ scenarios and were deployed on 5/1/21 per below.
• Invoice approval requirements were identified and signed off 6/4/21. Next is
development and testing with target rollout in late summer.
3. 3
Edited email alerts for invoice approval to make them clearer and provide more
information (e.g., more info on the invoice, link to training in Workday)
BUMG approval flows will be based on the cost center only, not cost center and
project combined
̶ No change to Research/Funds and other company 1 approval flows – project
will determine the approvers
Time outs – more specifically, invoice approvals (other than sub-contractor
invoices) will time out and move up to the next level after a specific number of
business days if the invoice has not been approved or rejected
Other Updates to Invoice Approvals
4. 4
Check AP’s pages on the Hub for current information
• Invoice handling process description
• Form for vendor adds, one-time payments, and recurring payments
• Tip sheets and link to Chrome River
• NEW tip sheet on running the Vendor Distribution report, which is available on the
Infor Management Reports page
• Chrome River reimbursements through AP can be seen on the Vendor Distribution
report
An approval and report access listing and the change request form are available on the
Infor Management Reports page
• Keep approvers for your areas updated – submit changes whenever someone starts,
gets promoted, transfers or leaves
• Review approvers on the listing periodically (quarterly)
Invoice handling
• Request new vendors before sending an invoice whenever possible
• If invoices come to you, forward to BMCHS_Invoices@bmc.org as soon as possible.
Invoices must be approved before they can be paid, so there will be time to review the
invoice after it’s sent for approval
How you can help us
5. 5
All Milestone projects are being calculated differently in V11:
̶ V9 Budget = Cash Received (open AR is excluded)
̶ V11 Budget = Total Invoiced (Includes both open and collected AR)
Milestone budgets will be updated the 5th business day of each month.
̶ CTO managed milestone projects are up to date
̶ RF managed milestone projects will be updated prior to the end of this month
Research Operations Updates
6. 6
Re-designing the CTO intake form and ancillary service intake forms
New smart forms are being utilized to centralize the flow of documents
Meetings with all Ancillary services have begun, with the first forms to be
modified being Radiology and IPS
Research Operations Updates
7. 7
Chris Sullivan - Staff update, new form will be sent shortly and background- ITS
Research Operations Updates
8. Who? What ? & Where?
Who?
Part of the BU Clinical Translational Science Institute(CTSI). We provide a
research area where study protocols are implemented. We also provide services
to BMC inpatient population and outpatient clinics.
What?
We support both clinical trials and socio behavioral studies
Where?
On the 8th floor of the Evans building
9. Protocols
COVID and Non COVID studies
Endocrinology ADAAMS Alzheimer Amyloidosis
Lupus PFIZER PEDI CTE ACTIV4A Gulf war Illness PRESTO
ACTIV 2 HIV PFIZER ADULT Pulmonary NICHE Psychiatry
11+82
GI ACTIV 1M Sickle cell PAH Asthma Genetics
Scleroderma PACT Nephrology Vasculitis
Rheumatoid Arthritis Oncology ACTIV 5 Exercise
training
11. Other Services
On demand extended hours and weekend
services
American Red Cross CPR certification
Phlebotomy training with National
certification
Limited IRB support
Research Job connection
12. LIFE DURING COVID
INCREASE STAFFING
7 24 (14 + 6 MPH + 4WS)
INCREASE DAYS AND HOURS OF OPERATIONS
MON TO FRI 0800-1600 MON TO SUN 0800-TBD
SHIFT IN SERVICES PROVIDED
STRICKLY CLICINAL CLINICAL AND COORDINATOR LIKE
NEW WORLD OF PPE , PRECAUTIONS AND CLEANING
CHANGE IN DAY TO DAY FLOW- SCREENING, MASKS,ENTRANCE, EXIT,
LIMITED NUMBER PEOPLE ON THE UNITCHANGES IN SCHEDULING
PROCESS
13. LIFE DURING COVID (cont.)
CHANGE BILLING STRUCTURE
LEVELS OF INTENSITY A LA CARTE-ITEMIZED
INTRODUCTION TO VELOS AND CLINCARD
CLARIFYING SOME BLURRED LINES/TIES BETWEEN
INSTITUTIONS
APPROXIMATELY 22 PROTOCOLS WERE IMPLEMENTED IN THE
PAST 13 MONTHS
APPROXIMATELY 11 HAVE COMPLETED ALL OF THEIR VISITS
AND/OR NO LONGER NEED GCRU SERVICES
14. 14
COVID-19 clinical research summary
and vision for Equity in Research
June 8, 2021
Because research must be inclusive to be
exceptional
15. 15
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
16. 16
Our goal is to embed clinical research into prevention and treatment for all
people, regardless of race or socioeconomic status—without exception
MISSION
To drive and share
world class science
discovery and
innovation through the
conduct of
community-based
participatory clinical
research and clinical
trials that are
responsive to cultural
and linguistic
differences and
inclusive of all
VISION
All people, regardless
of race, ethnicity,
language,
socioeconomic status,
sexual orientation,
gender identification,
insurance coverage,
or national origin, are
provided the
opportunity to
participate in
exceptional clinical
research
18. 18
BMC collaborated with GCRU to successfully develop and run a COVID
research program
16
COVID
interventional
trials completed
enrollment
Apr-May
Participants
Enrolled in
Interventional
Trials
576
1980
PARTICIPANTS
ENROLLED IN
SAMPLE
COLLECTION
PROTOCOLS
269
PARTICIPANTS
ENROLLED IN
VACCINE
TRIAL
686
COVID-RELATED
PUBLICATIONS
Actively
recruiting
COVID
Studies
6
CREATED
Biorepository
TO ADVANCE
COVID
RESEARCH
Compiled
55
data sets for
COVID related
research
Source: internal BMC data updated as of 05/2021
Participants
enrolled in
COVID
ambulatory
research
1844
19. 19
BMC patient voices are being included to advance medical practice
From intervention to market
COVID sped up the process
BMC site for trials proven effective
On average it takes 12 years for
an intervention to go from bench
to FDA approval
5 in 5000 drugs in preclinical
testing progress to human
testing
1 of the 5 drugs tested in
humans receives FDA approval
Chance for a new drug to make it to
market is ONLY 1 in 5,000
Pharma and NIH resources hyper
focused during COVID, most other
research was temporarily stopped
COVID vaccines developed and EUA
approved in less than 1-year
52 repurposed INDs tested to treat
COVID in less than 1-year
BMC selected as a site for 19 repurposed
INDs
Adult Pfizer COVID Vaccine Trial
PI: Dr. Elizabeth Barnett
Enoxaparin Anticoagulant Trial
PI: Dr. Naomi Hamburg
Regeneron Monoclonal Antibody
PI: Dr. Michael Paasche-Orlow
BMC continues to be selected as a site, now
focused on NIH ACTIV and Pfizer COVID
vaccines trials
20. 20
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
21. 21
The Biorepository is comprised of samples from BMC’s COVID-19 patients across
the lifespan and demographic backgrounds, and across the course of disease
A Scientific Review Committee of cross-disciplinary BMC and BU experts
oversees and allocates samples to investigators whose studies are systematically
reviewed and deemed scientifically rigorous
̶ The Biorepository Team is working closely with the CTO and CRN to collaborate on
incorporating community engagement initiatives into Biorepository governance
Close collaboration with the Clinical Data Warehouse (CDW) enables investigators
to link rich medical history and clinical data with patient samples
The Biorepository team is actively building the infrastructure and processes to
enable sample sharing with third-parties, including industry partners
̶ Sharing with third parties may generate new opportunities for collaboration with industry
and other academic centers
̶ Enables inclusion of BMC patients in groundbreaking research on novel diagnostics and
therapeutics
The COVID-19 Biorepository Enables Inclusion of BMC’s Diverse Patient
Population in Innovative COVID-19 Research
22. 22
The COVID-19 Biorepository by the Numbers (as of May 2021)
>4,000
sample
aliquots
collected
from cohort
>48,000
discarded
clinical
aliquots
collected
14
BMC/BU
studies
currently
supported
68%
of cohort
participants
are persons
of color
43%
of cohort
participants
have limited
English
proficiency
>10,000
Individual
BMC
patients
represented
17
unique
sample
requests
evaluated
1,885
samples
allocated or
released to
active
studies
23. 23
COVID-19 Biorepository Sample Sources and the Patient
Population and Disease Course Represented
Prospective Cohort
Participants
Participants enrolled in the COVID cohort study
(H-40047; PIs: Elizabeth Duffy and Jai
Marathe) provide informed consent for future
use of their samples by third parties, including
industry partners
Participants (≥18 yrs old) include:
• Inpatients diagnosed with COVID; samples collected
weekly thought hospital admission
• Outpatients diagnosed in clinic; samples collected 1
week, 1 month, and 2 months after diagnosis
• COVID survivors; samples collected 1, 2, 3, 6, 12, 18,
and 24 months after diagnosis
Samples include: serum, plasma, PBMCs, PAXgene,
saliva, NP/OP swabs, urine, and stool
Discarded Clinical Samples
Clinical samples (respiratory and blood
samples) from BMC patients are obtained at
the end of their clinical utility and banked for
future use through a waiver of informed
consent (H-40115; PI: Stephen Pelton)
• Samples collected from COVID patients of all ages
(including pediatric) from time of diagnosis onwards,
representing acute and convalescent illness
• Both single timepoint and sequential samples from
individuals
• Repeat samples from patients with persistent positive
results or future positive results indicative of persistence
or repeat infection
• Samples from vaccinated and unvaccinated patients
• Samples from COVID negative patients also available
Samples include serum, plasma, and NP/OP swabs
Autopsy Tissue Samples
Tissue samples collected through autopsy of
deceased COVID-19 patients whose families
consented for collection for future use for
research
Research autopsies conducted on 36 patients, 12 of which
were COVID+
Samples include frozen and formalin fixed samples of lung,
kidney, and spleen
24. 24
Learn more about our COVID-19 Biorepository on the web
www.bmc.org/research/covid-biorepository
25. 25
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
26. 26
Developed a virtual COVID repository to expedite data requests and facilitate data
consistency for COVID research in various departments
Collaborated with the prospective biorepository PI & project manager through multiple
iterations of dataset to account for the evolution of COVID data sources and disease
trajectory
Compiled data sets and cohort for 55 COVID-related research projects
Completed daily reviews of COVID data sources to ensure data quality and validation
Supported recruitment for COVID treatment studies with daily reporting of eligible COVID
positive patients meeting various study requirements
Provided a weekly extract for public health reporting to CDC and publication in MMWR
Clinical Data Warehouse Supporting COVID-19 Research
27. 27
• Working towards expanding
data availability through
streamlining access to
Community Health Center
and claims data
• Incorporating common data
models to allow our data to be used
with external data sets
• Integrating external datasets to connect
environmental and social data to clinical
data
COVID Accelerated Existing CDW Initiatives
• Social informatics
• Create definitions and
methods to identify BMC
special populations & health
equity variables
• Household linkages, social
determinants of health, geocoding,
environmental factors
• CDW simultaneously began to focus on foundational
data quality, optimization, & validation efforts
• Certain demographics, diseases and clinical
outcomes are not always straightforward
nor consistent within the EHR
• CDW established the advisory
committee and scientific director for
clinical validation
• Developing standardized
workflows and creating
various resources to ensure
data quality, consistency,
effectiveness and efficiency
• Emphasis on Covid-19 data quality highlighted
infrastructure and optimization hindrances to facilitating
research
• CDW shifted focus to foundational efforts
• Improved internal processes for
requesting data and monitoring
revenue
• Developed a procedure
manual, metrics dashboard
& automated project
management and billing
system
Foundational
Logistics
Foundational
Science
Aspirational
Efforts
Inclusive
Research
28. 28
1. Clinical research mission, vision, and high-level COVID-19 summary
2. Biorepository impact, purpose, and usage (prospective and discarded
samples)
3. Clinical Data Warehouse impact, purpose, and usage (CDW)
4. Building a community engaged culture: Clinical Research Network (CRN)
Contents
29. 29
CEAL award imbedded into the CRN structure; allows for rapid response
to demanding NIH timeline and milestones
30. 30
CRN Year-one objectives and goals in a phased approach
Phase I Phase II
1. Oversee
financial and
regulatory
lifecycle of ACTIV
trials
2. Define CRN
scope and intake
evaluation
process
Build ACTIV and
CEAL annual
demographic
dashboards for
clinical research
enrollments to
develop baseline
measures
Create a Clinical
Research
Community
Advisory Board
(CAB),
collaborate with
CTSI Community
Engagement
(CE) Core
Sponsor annual
campaign around
clinical research
awareness for
BMC and BU
staff and faculty
1. Co-develops future
PI educational series
with BU/BMC research
administration
2. Hosts clinical
research seminars with
DOM & BU
3. Attend pre-existing
clinical staff meetings
at BMC and CHCs
4. Create website to
host clinical research
material
Assess value in
creating a BMC
Research Registry
to establish a
database for
individuals
interested in
awareness around
research
31. 31
Within 2-months of CRN inception, reporting transparency, and focus is
made clear on how to set clear objectives around inclusive research
metrics, but there is work to be done
32. 32
BMC is well positioned to join the CEAL Alliance
Strong Community
Partnerships
ACTIV COVID
Network Site
6trials
12Community
Health Centers
Leading Edge
Research
7Community
Vaccination
Sites
Coalition of
Physician
Ambassadors
32%
of BMC patients
are Non-English
Speaking
New England’s
Largest Safety Net
Hospital
70%
of BMC patients
are underserved
minorities
856K
Outpatient Clinic
Visits
Editor's Notes
Hospital leadership, GCRU, and Principal Investigators worked tirelessly to offer trial opportunities to BMC patients admitted
Publications reported include: BUSM, BMC, and BUMC
Snapshot of Demographics and research dashboard, many more data to share. Discuss the need for central reporting of participant enrollment into Velos: Clinical Trial Management System.
