Clinical Trials Workshop presentation

Clinical Trials Workshop
Thomas Landis, Senior Grants and Contracts Officer
Erika Waday, Information and Training Specialist
Jennifer Bingham, Grants and Projects Analyst II
Clinical Trials Process Overview
Contemplating a Clinical Trial
• Confidentiality Disclosure Agreement (CDA)
• Study Materials Released to PI
• PI Agrees to Undertake the Clinical Trial
Confidentiality Disclosure
Agreement (CDA)
• Purpose: To allow the sponsor to release study materials
which contain confidential and proprietary information to the
PI and the study team in order for them to determine whether
they want and can perform the study.
• Parties: Sponsor and NSHE obo UNR, with PI often signing as
“Read and Acknowledged.”
• Common Issues: Narrowing the definition of “confidential
information,” limiting the length of the agreement, limiting
the obligation of efforts to be taken to protect confidentiality.
Pre-Trial Preparation
Clinical Trial Agreement (CTA)
OSP-1 Transmittal Form
Negotiating the CTA and Informed Consent Form (ICF)
Negotiating the Budget
IRB Approval
Initial Funding, Account Setup and the OSP-22 Budget Setup
Clinical Trial Agreement (CTA)
• What? It is the agreement which establishes the legal
relationship between the Sponsor and the Site and sets the
rules under which the study will be conducted.
• Who? Parties are the sponsor and Board of Regents, NSHE,
obo UNR with the PI typically signing as “Read and
• Role of UNR OSP? To ensure that NSHE contractual policies
and procedures are followed and to protect NSHE and the
study team as much as possible.
OSP-1 Transmittal Form
• What? The OSP-1 Transmittal Form acts an informational cover form for
all proposals forwarded to the Office of Sponsored Projects (OSP).
• When? The OSP-1 should be completed and submitted when the PI has
decided the accept the study. This is typically after study materials have
been reviewed and the site has been approved by the Sponsor and
perhaps the CTA has been sent out.
• Why? Some information is needed for the proposal submission process
while other information is collected for institutional reporting purposes.
And, some of the information collected, such as the certifications,
satisfies policies with which UNR must comply.
• Requirement: The form must accompany any proposal submitted to
OSP, must be completed in its entirety and must be signed by all
involved project investigators, chairs/directors and deans. Instructions
on completing the OSP-1 form are included in your handouts.
Negotiating the CTA and ICF
Role of OSP: To negotiate terms and conditions of the agreement to
ensure NSHE policies and procedures are adhered to and NSHE and
study team are protected.
Typical Issues
• Term: Sponsors want open-ended project period while UNR prefers
to limit project period to < 5 years to avoid chancellor signature.
• Subject Safety: Request terms in accordance with the Association for
the Accreditation of Human Research Protection Programs
(AAHRPP) requirements.
• Subject Injury: Try to make sponsor responsible.
• Confidential Information: Try to limit in similar fashion to CDA; helps
preserve PI publication rights.
Negotiating the CTA and ICF
• Intellectual Property (IP) and Publication: As much as possible, try to
protect PI’s/NSHE’s right to IP developed in course of study; remove
barriers to publication.
• Indemnification: Limit indemnification language to NSHE requirements.
• Coordination with Study Team: Assist in communicating with and
conveying to sponsor all agreement paperwork and other information in
preparation of study.
• Review ICF to ensure it meets AHRPP guidelines and is consistent with
terms in the CTA regarding subject injury and indemnification.
Role of PI and Study Coordinators: Negotiate budget, initiate request for
IRB approval to generate ICF, provide input and approval as to CTA terms
to OSP and coordinate with OSP in transmitting CTA “package” to sponsor.
Negotiating the Budget
• Site Charges vs. Per Patient Charges: Site charges are out-ofpocket expenses incurred by site such as IRB fees, dry ice and
storage charges. Per patient charges are payments to be made
to site for visits and procedures performed on each patient.
• Budgeting Facilities and Administrative Costs (F&A): UNR is to
receive 26%, representing the off-campus rate for research, on
revenues from studies. Sound strategy must be used to
negotiate the budget in order for F&A and site’s costs to be
IRB Approval
• Application for approval is initiated by PI.
• Typically, an external IRB (WIRB) is used but external WIRB is
not required.
• IRB approval is required in order for a UNR account to be
• End date of UNR account cannot extend beyond IRB approval
end date. PI must ensure that approval is extended to extend
Initial Funding, Account Setup
and the OSP-22 Form
• Initial funding: Generally, start up funding for a clinical trial is
the minimum necessary to get the project off the ground.
Once the OSP-1 form has been routed to OSP and any
necessary IRB approvals are in place, the project spending
account can be opened.
• Account Setup: A project spending account will be opened for
project expenditures. As revenue is received, the spending
authority on the account increases.
• The OSP-22 form: The OSP-22 form is used to indicate how
funding will be budgeted in the account. An OSP-22 form will
be needed for the amount of initial funding.
Clinical Trials: Post-Award
• Invoicing Sponsor
• Recognize Revenue and Issuing the Notice of Award (NOA)
• Controller’s Office Role
• Closeout
Jennifer Bingham
Post-Award Analyst
[email protected]
Invoicing Sponsor
When payment is based upon case report forms, you (the site)
will bill the sponsor directly for patient visits. If payments can’t
be submitted by case report, OSP will bill on your behalf.
Examples of costs for which most sponsors need to be directly
Start-up Fees
Pharmacy Start-up Fees
IRB Fees
Dry Ice
Screen Failures
Travel (Patient)
Chart Review
• Questionnaires
• Per Subject Cost (5% withheld by
• Record Archiving Fee
• Coordinator Fee
• Patient Stipend or any other charges
that may come up (see example
Clinical Trial Patient Invoice and Other
Charges Invoice)
Recognizing Revenue & NOAs
• Once a check has been received and posted in UNR’s
accounting system, CAIS, an updated NOA will be sent to the
PI and support staff to recognize revenue. At that time, the
back up for the check will be sent via email to the site
coordinator so they can reconcile their record.
• If no back-up was provided by the sponsor, OSP will email the
sponsor to request the back-up documentation. Once
received, the back up will be forwarded to the site. In the
event that it is unknown in what account to deposit the
revenue or the check was deposited into the wrong account,
OSP will not update the NOA until the sponsor provides back
up documentation.
Controller’s Office Role
• The Controller’s Office/Cashier’s role in the clinical trial
process is to identify where to credit the check, either to the
invoice number or into the correct account(s). The check and
any backup documentation provided by the sponsor will be
forwarded to OSP.
• All payments should be sent to the following Controller’s
Office billing address:
Board of Regents
Attn: Controller’s Office/Cashier
1664 N Virginia Street Mail Stop #124
Reno, NV 89557
• Once OSP is notified by the site or receives an IRB Closure
form stating the clinical trial has come to an end, closeout
procedures may begin.
• Upon commencement of closeout procedures, the Sponsor’s
Payments made to vend report is requested. The PI on the
project will be emailed the Clinical Trial Closeout Checklist and
Certification form.
• When all payments are received from the sponsor and the
clinical trial closeout form is completed by the PI, closeout is
completed on the OSP end. Any excess money will be moved
to the PI’s Miscellaneous Program Development Account.
• OSP Website:
• Controller’s Office Website:
• Research Integrity Office (oversees the Human Research
Protection Program) Website:

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