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Penn State Hershey Research
Dan Notterman, MD Vice Dean for Research
Sheila Vrana, PhD Associate Dean for Research
Who’s my person?Department Person Department Person Department Person
ANYTHING basic science Lou Medicine – Endocrinology Stacey Neurology Stacey
Anesthesiology Stacey Medicine - Infectious Disease Stacey Neurosurgery Stacey
Biochemistry & Molecular Biology Lou Medicine - Heart & Vascular
Institute Barb Obstetrics & Gynecology Stacey
Cellular & Molecular Physiology Lou Medicine – Gastroenterology Stacey Ophthalmology Stacey
Commonwealth of Pennsylvania Barb Medicine - General Internal Stacey Orthopedics Stacey
Comparative Medicine Lou Medicine – Nephrology Stacey Pathology Lou
Dean's Office Lou Medicine - Pediatric Oncology Paul Pediatrics Paul
Dermatology Barb Medicine - Radiation Oncology Paul Pharmacology Lou
Emergency Medicine Stacey Medicine – Pulmonary Stacey Psychiatry Paul
Family & Community Medicine Stacey Medicine – Rheumatology Stacey Public Health Sciences Lou
Humanities Lou Microbiology & Immunology Lou Radiology Stacey
Medicine - Cancer Institute Paul Neural & Behavioral Sciences Lou Surgery Paul
Where do I start?
CDA – Jill Wagner, Tech Development Before you can see Sponsor
information, you agree to keep it confidential
Internal Submission
ePIAF Internal form for approval Originally developed for grant
applications Database for reporting Declare conflicts
Principal Investigator / Department
Sponsor
Government, Industry,
Foundation, Department
Agreement
Execution/
Award
$ Other BiosafetyConflict of InterestCOM Controller’s OfficePFS/FinancePublic Health SciencesResearch Quality AssuranceRisk Management
Office of Research Affairs
Clinical Trials Office
HSPO/IRB
Office of Technology Development
Clinical Research Center
Marketing & Communications
What does Sponsor want?
Test a new drug or device Test a new use of an approved
drug/device Control cost Enroll fast Own and control the data
Publications Intellectual Property
What do We Want?
Help our patients Participate in research Publish Use research data internally Teach our students Maybe generate a little margin
Set the rules
Everyone follows the laws as they apply to their role
Everyone protects the patient Everyone gets to publish Everyone agrees to share
What’s in the Contract
Relationship of the Parties Clearly state that neither party is an
agent or employee Independent contractors
Notices To assure that both parties trust that
communications are received Where to send What is acceptable
What’s in the Contract
Term/Termination Effective Date and Expiration
Sets period for budget/fund in IBIS Early termination
Breach Safety Sponsor said so Change in PI
Effective of termination
What’s in the Contract
Use of Name Approval of the other party
Except reporting Biosketches / grant applications
Assignment Sponsor assigns to CRO
Survival Clauses
Articles in the Contract
Order of precedence Contract vs Protocol
Governing Law Pennsylvania or silent
Payment / Invoicing Addresses
Publication
Usually multi-center publication first ICMJE and Clinicaltrials.gov both
require study results to be public Allow sponsor review for confidential
info / patent
Confidentiality
Mark things confidential Protect confidential things Set a term, but within rules for
publication
Intellectual Property
If something new develops, who owns it Agree to disclose new developments Applies to PI and all study staff
Indemnity
“the act of making another “whole” by covering or guaranteeing any costs are incurred contractually in a trial Legal process and fees Expenses required to care for study
subject
Indemnity
Subject injury Sponsor’s use of data Product liability
Unless… Negligent Don’t follow protocol/instructions Natural progression of disease
Subject Injury
Sponsor reimburses charges related to injury
Institution arranges treatment Contract provision matches consent
form
AAHRPP
Voluntary program Protect the participants
Data / Safety Monitoring Board On-site monitoring
Guest Account Access Form Share adverse event info, during and 2
years after study
The Stars Align!
Final contract language and budget CTO does final congruence Contract Person assembles papers PI signs first Vinnie Falvo signs for COM Kevin Haley signs for HMC
FULLY EXECUTED AGREEMENT!
Statement of Award Establishes fixed dates for IBIS Awards a specific dollar amount