Contracts

Penn State Research

Penn State Hershey Research

Dan Notterman, MD Vice Dean for Research

Sheila Vrana, PhD Associate Dean for Research

Contracts Team x4196

Stacey Cleary

Lou Porter

Paul Primrose

Barb Suchanec

Robinn Moyer

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

Into the queue

ePIAF generates an OSP# Email to CTO and ORA Schedule budget feasibility meeting

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

The Contract

Establish the rules before the game. Players Positions Protection Payment Problems

The Players

Penn State and the Medical Center The Investigator The Sponsor Maybe a CRO

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

Wildcards

Master Agreements Amendments Export Control Extension Requests

Federal Flow-through

FDP templates Sort of like a Master Agreement Annual project period

Be involved!

ROAR RQA Lunch Lectures IRB workshops Tech Development Workshops ACES

Questions?