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eBHRC / API Shanghai Health Study Meeting AGENDA-DRAFT
March 29,2007
8:00 AM Continental Breakfast
8:30 AM Meeting Begins
Mid morning break
Noon
Lunch
1:00 PM
Call with Dr. Richard Irons
4:00 PM
Adjourn
I. Administrative
Establish Quorum Patsy Clegg
Identify Note taker Patsy Clegg
Antitrust Reminder John Wagner
Agenda Review
Patsy Clegg
Introductions
All
Objectives of Meeting: 1. Path forward agreed for execution of contracts to fund SHS 2. Revised Budget Approved 3. Roles and Responsibilities ofBHRC and API clarified
II. Proposal for consensus on funding SHS via CinPathogen Brian Doll
III. Technical Committee Report on Science Review of Dr. Irons Proposal
IV. Roles and Responsibilities
A. Special Programs Committee B. API Contracting Process for SHS C. API / BHRC members contract review E. API Policies & Procedures F. BHRC Roles & Responsibilities Document G. Communication Processes H. Use of SHS vs. API Letterhead I. Study Ownership
Charlie Williams Brenda Hargett ALL Howard Feldman ALL
See attached documents below
A. BHRC / API Contract
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"Benzene Consortium 01-4746 Final 8-31-0
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SH ELL-MCCLU RG-066426
"China Benzene Consortium 01-4746-
B. API Policies and Procedures
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"API Commitments "API Delegation of "API standards of
Environmental and HI S-14-04.pdf" Authority S-14-04.pdlconduct 12-01-04.pdl
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APIspecial_program_
activity_10_20_0S.pc
C. Roles and Responsibilities Document
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BHRC%20Roles%20 and%20 Responsi bi Iiti
D. Communication Processes
1. Consortium ---- API
2. Consortium ---- Dr. Irons
3. Consortium ---- SRPIERP
4. API
---- Dr. Irons
5. API
---- SRPIERP
6. Consortium ---- API ---- Special Programs Committee
13lIFlC -------------~ Special Programs Committee ---~ Exec 130ard
API -----------------~
7. Consortium 8. Consortium
API ---- Exec Committee API ---- Legal counsel
E. Use of SHS / API letterhead
F. Whose study is it?
IV. Study Funding Proposal
A. Criteria/Clarifications needed to initiate contracting 1. Technical - Review Agenda Item II 2. Consortium 13usiness Review 3. API Contracting Criteria
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SH ELL-MCCLU RG-066427
4. API Internal Approvals 5. Plan
See attached reference documents below.
A. Irons proposal
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"Cinpathogen DPME Cover Letter3_19_07
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DPMEMasterFinal3_1
8_07.doc
1. CinPathoGen documentation
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"Cinpathogen
"Cinpathogen
"Cinpathogen
qualification-1.txt" qual ification-2.txt" Certification II.txt"
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"Cinpathogen - CO "Cinpathogen - DE
Certificate of Good StCertificate of Incorpo
University of Colorado Letter
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"Feldman-Shanghai Health Study 3-27-07
2. Irons response to 18t BHRC Proposal
ResponseJGL2_28_0 7.doc
B. API Contract Requirements:
Process
1. Proposal Reviews a. BHRC reviews for scope of work and funding level b. API reviews for contract criteria
2. Contract drafted and reviewed by a. API CFO, legal, xxx b. BHRC reviews
3. API seeks Exec committee concept approval while contract being written and reviewed
4. BHRC signs amended contracts with API
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SH ELL-MCCLU RG-066428
5. API signs contract (This can occur prior to BHRC contracts being executed; verbal confirmation from CEO needed to send contract to irons prior to contract going to Irons for execution)
6. CinPathogenlIrons signs contract 7. Funds dispersed
Criteria to be met
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"API Proposal Guide for Prospective Contri
C. BHRC Technical Committee Review
D. Funding Commitment
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"BHRC meeting - nelol budget proposal - De
"BHRC timing of sponsor payments - J
E. Terms of Funding Commitment
"Proposed Conditions for 06 increased fund
V. Budget Revision Approval
"BHRC meeting - nelol budget proposal - De
VI. Next Call / Meeting VII. Adjourn
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SH ELL-MCCLU RG-066429