Business Operations
Pre-Award
Confidential Disclosure
Agreements (CDA)/
Non-Disclosure Agreements (NDA)
Two Types
• One Way
• A company may want to send a protocol to the Principle
Investigator (PI) so that he/she can decide whether to
participate in the trial
• The protocol will have confidential information that the company
needs to safeguard
• The sponsor may wish to support a Principal Investigator by
supporting travel to a conference which may have confidential
information
• Two Way (Mutual) or One Way Out
• A Principal Investigator may want to request a sponsor to
support their own research
How does this work?
• Principal Investigator contacts University administration
looking for assistance
• Sponsor contacts PI/Coordinator
• Sponsor contacts University administration
• In order to protect the University and the PI, all CDA’s
require University signature
• Each must be reviewed, negotiated and executed by the PI,
University Official and the Company.
Negotiation
• CDA’s are usually straightforward and require little negotiation
• Point of contact: Roseann Talarico – 3-4743
roseann.talarico@jefferson.edu
• Most are negotiated within 5-10 business days
• Include the name, address, telephone number and the
Sponsor/CRO email/phone
• If needed, include a note with any concerns about the CDA or what
confidential information University may wish to protect
• Once completed PI will receive executable copy – return to
complete the execution process
• Fully executed copy sent to PI for recordkeeping
What is required to begin the business process?
• Possible indicators
• CDA executed
• Cancer Center
• MDG/PRC approvals
• Department contacts business office
• Electronic Proposal Transmittal Form (ePTF)
• What is it/what is it for?
• It is an electronic mechanism for Jefferson to manage, maintain,
and approve research
• Used for all research at Jefferson
Electronic Proposal Transmittal Form (ePTF)
What is needed?
• Materials required to complete (ePTF) for approval
•
•
•
•
•
Protocol
Investigator Brochure (IB)
Draft Informed Consent (ICF)
Clinical Trial Agreement (CTA)
Sponsor Budget
Electronic Proposal Transmittal Form (ePTF)
What is the approval process?
• Clinical trials
• First Round approval
• Contract/MCA/Budget
• Process may begin
• Second round approval
• MCA/Contract/Budget negotiated
• IRB approval letter and informed consent
JCRI Business Operations
Coverage Analysis & Budget
Coverage Analysis
Materials needed to conduct a Coverage Analysis
From Study Team:
• Same as (ePTF) process
•
•
•
•
•
Protocol
Investigator Brochure (IB)
Draft Informed Consent (ICF)
Clinical Trial Agreement (CTA)
Sponsor Budget
• Approved electronic proposal transmittal form (ePTF)
• First round only
What is a Coverage Analysis?
• Document that determines the appropriate payor (i.e.
Sponsor, Medicare or third party payor) for each item and
service required by a clinical research trial
Why is a Coverage Analysis important?
• Reduces risk for submitting false claims
• Billing for services not part of a qualifying clinical trial
• Billing for items and services promised/paid for by Sponsor
• Billing for research only items and services
• Assists in budget negotiations with Sponsor/CRO
• Identifies costs that need to be accounted for in the sponsor
budget
• Basis of billing compliance/audits
• Provides evidence of due diligence and a mechanism for
compliance with billing rules
Coverage Analysis Process
• Receive all materials from the study team
• Create a grid that reflects all clinical events and time points
in the protocol
• Review clinical guidelines along with CMS national and local
coverage determinations to identify the appropriate payor
for each event
• Send the CA to PI/SC for review and approval
• Approve or revise the CA as necessary
Items and Services
CPT/HCPCS
Codes
Time & Effort
Informed Consent
N/A
Inclusion/Exclusion Criteria
N/A
Medical History
N/A
Concomitant Medications
N/A
Adverse Event Assessment
N/A
Evaluation & Management Services
Complete Physical Exam
99201 - 99205;
99211 - 99215
G0463
Cycle 1
Month 1
Day
Day 1 Day 8
15
Q1/Q0
Mod
Screening1
No
No
No
No
No
S
S
S
S
S
S
S
Q1
M
M
S
S
S
S
Cycle 2
Month 2
Day
Day Day
Day 43
Day 64
22
50
57
S
S
S
S
S
S
S
S
S
S
This
This
This
This
This
is
is
is
is
is
not
not
not
not
not
a billable item
a billable item
a billable item
a billable item
a billable item
or service.
or service.
or service.
or service.
or service.
Vital Signs
N/A
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
According to the NCCN Clinical Practice Guidelines in Oncology Multiple Myeloma
Version 2.2014 "NCCN Guidelines" a physical exam is considered conventional
care at workup (NCCN Guidelines, p. 6). Patients in this trial have a confirmed
diagnosis of relapsed/refractory multiple myeloma after treatment with at least two
different previous regimens. Prior treatment must include at least two standard antimyeloma therapies or induction therapy followed by autologous stem cell transplant
(Protocol, p. 23). The study drug given in this trial has unknown side effects. A
physical exam at screening, once per cycle and at response assessments appear
reasonable and necessary for the clinical management of the patient in order to
monitor disease progression and potential side effects. Coverage supported by NCD
310.1.
This is a bundled service, and is not billable.
Weight
N/A
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
This is a bundled service, and is not billable.
N/A
No
NA
85025
or
85027 and 85007
Q1
M
M
M
M
M
M
M
M
M
80053
Q1
M
M
M
M
M
M
M
M
M
93000 - 93010
No
S
S
J9999
Q0
NB
NB
NB
NB
NB
NB
NB
NB
96365-96368
Q1
M
M
M
M
M
M
M
M
Height
Labs
CBC with Differential
Comprehensive Metabolic Panel
Scans/Procedures
Electrocardiogram (EKG)
Study Medications
ALT-803 (IV)
IV Infusion (ALT-803)
Coverage Code Key
M: Medicare or Other Heath Plan
S: Charged to Study Fund or Sponsor
NA: Bundled With Another Payment From Third Party
NB: Not Billed to Anyone, Not a Billed Event, No CPT Code
M
Comments
This is a bundled service, and is not billable.
S
A CBC with differential is considered conventional care at initial workup (NCCN
Guidelines, p. 6).
The study drug, ALT-803, caused an increase in white blood cell counts in animal
studies (Protocol, p. 18-19). Patients in this trial have multiple myeloma which also
affects blood counts. CBC testing throughout treatment appears to be done both for
the clinical management of the patient and to monitor, assess and treat for
potential complications associated with the study drug. Coverage supported by
NCD 310.1 and NCD 190.15.
The study drug, ALT-803, caused a decrease in total protein and albumin levels in
the blood, as well as decreased blood calcium levels in animal studies (Protocol, p.
18-19). CMP testing throughout treatment appears to be done both for the clinical
management of the patient and to monitor, assess and treat for potential
complications associated with the study drug. Coverage supported by NCD 310.1.
The study drug does not appear to have cardiac side effects, and states that "no
dose related abnormalities based on ECG or ophthalmic evaluations were
The study drug will be provided by the sponsor. The protocol states: "ALT-803 is an
investigational drug supplied to investigators by the Altor Bioscience Corporation at
Miramar, Florida. Sufficient study drug will be available for this protocol to treat all of
IV administration of the study drug is supported by NCD 310.1.
Clinical Trial Budget
Develop a financial plan that encompasses all phases
of the study:
•
•
•
•
Start-up costs
Institutional costs
Other costs incurred throughout the study
Subject costs
Develop a financial plan that encompasses all phases
of the study:
• Start-up costs
• training, meetings, IRB/regulatory work, source document
creation
• Institutional costs
• Other costs incurred throughout the study
• Subject costs
Start-Up Costs
Activity
Study Feasibility Assessment (database review, medical records, recruiting/advertising
preparation)
Site Qualification Visit preparation and attendance
Regulatory Documents Preparation, Submission, Collecting Signatures (FDA 1572, CVs, W9,
etc)
IRB Documents Preparation, Submission, Collecting Signatures, Queries (Proposal
Transmittal, Informed Consent, etc)
Source Document Creation
Site Initiation Visit preparation and attendance
PI Staff Meetings, Training, Hiring, Communications
Total admin start up
Hourly Rate + 26.3% fringe
PI (weekly salary / 40 hours)
Research Coordinator (weekly salary / 40 hours)
Charge
Hours
PI hours RC hours
$
$
525.41
247.23
8.00
4.50
1.6
0.45
6.4
4.05
$
933.99
17.00
1.7
15.3
$
$
$
$
$
836.11
1,326.15
604.35
520.51
4,993.74
16.00
30.00
11.00
10.50
97.00
1.2
0
1.1
0.525
6.575
Hourly
w/ Fringe
$ 120.00
151.56
$ 35.00
44.205
14.8
30.00
9.9
9.975
90.425
Develop a financial plan that encompasses all phases
of the study:
• Start-up costs
• training, meetings, IRB/regulatory work, source document
creation
• Institutional costs
• F&A, IRB fees, billing compliance fees
• Other costs incurred throughout the study
• Subject costs
Develop a financial plan that encompasses all phases
of the study:
• Start-up costs
• training, meetings, IRB/regulatory work, source document
creation
• Institutional costs
• F&A, IRB fees, billing compliance fee
• WIRB/Quorum – One time fee $2,500
• Other costs incurred throughout the study
• site monitor fees, IRB work on continuing reviews or
amendments, dry ice, close-out costs, etc.
• Subject costs
Other Costs
Recruitment
Pharmacy Start Up
Pharmacy Monthly Maintenance
Pharmacy Close Out
IRB Submission Work on Continuing and Ammendments
UAE Submission to IRB (FDA required 24-48 hours)
IND Safety Reports (Per Report)
Advertising
Reconsent Fee
Amendment Administrative Fee
Study Close-Out
Document Storage
Site Monitor Visit Fee
Sponsor/FDA audit
Dry Ice
Equiptment/Supplies
Develop a financial plan that encompasses all phases
of the study:
• Start-up costs
• training, meetings, IRB/regulatory work, source document
creation
• Institutional costs
• F&A, IRB fees, billing compliance fee
• WIRB/Quorum – One time fee $2,500
• Other costs incurred throughout the study
• site monitor fees, IRB work on continuing reviews or
amendments, dry ice, close-out costs, etc.
• Subject costs
• Any items that are not billable to insurance or provided by the
sponsor
CPT/HCPCS
Codes
Cycle 1
Month 1
Day
Day 1 Day 8
15
Cycle 2
Month 2
Day
Day Day
Day 43
Day 64
22
50
57
Cost
Screening1
N/A
N/A
N/A
N/A
N/A
99201 - 99205;
99211 - 99215
G0463
N/A
$150
$100
$75
$50
$50
Q1
$150
$100
$75
$50
$50
M
$50
$50
M
$50
$50
$50
$50
$50
$50
$50
$50
M
$50
$50
$50
$50
$50
$50
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
N/A
No
NA
NA
NA
NA
NA
NA
NA
NA
NA
N/A
85025
or
85027 and 85007
No
Q1
NA
M
M
M
M
M
M
M
M
M
M
80053
Q1
M
M
M
M
M
M
M
M
M
M
36415 or 36592
93000 - 93010
J9999
Q1
$130
No
M
$130
IV Infusion (ALT-803)
PI
96365-96368
N/A
Q1
$150
Study Coordinator
Total Direct Costs
Indirect Rate 30%
Total Costs
N/A
$150
Items and Services
Time & Effort
Informed Consent
Inclusion/Exclusion Criteria
Medical History
Concomitant Medications
Adverse Event Assessment
Complete Physical Exam
Vital Signs
Weight
Height
CBC with Differential
Comprehensive Metabolic Panel
Venipuncture
Electrocardiogram (EKG)
ALT-803 (IV)
$130
NB
NB
NB
NB
$130
NB
Total
$150
$100
$75
$450
$450
M
NA
M
$390
NB
NB
NB
$150
M
M
M
M
M
M
M
M
$150 $150 $150 $150 $150 $150 $150 $150
$1,350
$150
$855
$257
$1,112
$150
$530
$159
$689
$1,350
$4,315
$1,295
$5,610
$150
$400
$120
$520
$150
$400
$120
$520
$150
$400
$120
$520
$150
$530
$159
$689
$150
$400
$120
$520
$150
$400
$120
$520
$150
$400
$120
$520
Accomplished by considering all stakeholders input:
•
•
•
•
•
•
•
•
PI and Study Coordinator
Radiology
Pathology
Pharmacy
Hospital Billing
Professional Services Billing
Other departments
Sponsor
Clinical Trial Agreement
What is required to complete a contract?
• Who wrote the protocol?
• Sponsor
• Clinical Trial Agreement
• PI/Jefferson
• Investigator Initiated Agreement
• Is the sponsor contract new or previously negotiated?
• If new – review/red line changes
• Forward to legal
• If previously negotiated – similar protocol
• Review/red line changes
• Forward to sponsor
What is required to complete a contract?
• Negotiate terms
• Ensure budget, billing and payment terms are acceptable
• Is the IRB approved?
• Approval letter and informed consent reviewed
• Sponsor and protocol must match contract
• Subject injury and indemnification language
• Different terms in each but intent must be the same
• (ePTF) secondary approvals
What is required to complete a contract?
• Execute
• Forward to PI
• Return to sponsor
• PDF or mail
• Account set up
• Establishment letter to staff and accounting
• MCA includes account number sent to staff and billing
Post Account Establishment
• Modifications/Amendments
• No cost extension
• Change in PI
• Modification to protocol
• No budget modification
• Modification to protocol
• Budget modification
• $5,000 or greater
• (ePTF) supplement
• Approvals, etc.
• Follow same SOPs as a new clinical trial
How to initiate the process
Please, please, and please reach out to your clinical research
administrator for more information.
•
•
•
•
•
•
•
Ronald Polizzi, Director, Business Operations JCRI, 3-2127
Michael Caggiano, Team Lead, 3-4746
Jennifer Lott, Team Lead, 5-2546
Jenny Campbell, Clinical Research Administrator, 3-4282
LouEllen Daniel, Clinical Research Administrator, 3-5390
Ryan Massimilla, Clinical Research Administrator, 3-2890
Mary Rose Taft, Clinical Research Administrator, 3-4265