Document dnww9aBYdEgyamajz1yapq29e
To: BenzConsort-OC@listserve.api.org <BenzConsort-OC@listserve.api.org>;
BenzConsort-TC@listserve.api.org <BenzConsort-TC@listserve.api.org>; BHRC Communications Committee
<benzconsort-cc@listserve.api.org>; myron.c.harrison@exxonmobil.com <myron.c.harrison@exxonmobil.com>
From:
Russell White <whiter@api.org>
Cc: Bob Greco <Greco@api.org>
Bcc:
Received Date:
2007-04-1418:45:17 GMT
Subject:
Shanghai Health Study - conference call on Monday, April 16 at 5 PM EDT
There will be a Oversight Committee conference call to discuss the Shanghai Health Study at 5 PM EDT (4 Central, 2 Pacific) on Monday, April 16.
Attached is a draft set of potential deliverables for the contract with Cinpathogen. I reviewed most of them yesterday with Dr. Irons. I should have a draft gap analysis for you before Monday's call.
Draft agenda 1) Establish quorum and notetaker - Patsy 2) Antitrust reminder - Mark 3) Review and modify agenda - Patsy 4) Update on acknowledgement of API letter - Howard 5) Review draft deliverables - Russ 6) Review draft gap analysis - Russ 7) Next call - Patsy
>
Conference call:
Toll Free Dial-In Number: (866) 443-0059 International Dial-In: (770) 765-9147
Enter this code at the prompt: 202 682 8344# Operator-Assisted Service:
Toll-Free Dial-In Number: (800) 572-9844 International Dial-In Number: (706) 643-1733 Call Participant Functions *0 Operator assistance *6 Mute your own line
Russell White Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070
Tel: 202-682-8344 Fax: 202-682-8270
Attachments: CINPATHOGEN DELIVERABLES DRAFT 4-14-07.doc
SHELL-MCCLURG-061960
DRAFT CINPATHOGEN DELIVERABLES
Within five calendar days of the receipt of funds, Cinpathogen will identify progress
milestones to be achieved in the second quarter, 2007;
1. Update of the estimated NHL case numbers by ICD-9 classification in May 2007. [I
would recommend dropping this deliverable and instead request updates based on
lymphoid neoplasms (WHO) with documented informed consents and work history
questionnaire administration for all cases and controls,]
2. Documentation of data flow and data entry for QA team
a. Including review of SOP for data handling of work history information by the
QA/QC team (including data-out, e.g., the virtual link between diagnostic data
and exposure history data.)
3. Reestablish case accrual at participating Shanghai
a. Finalize arrangements for review of original
Otto Wong or his associates as necessary*
4. Reestablish necessary exposure assessment
of exposure
matrix
*In cooperation with the independent QA/QC
Within fourteen calendar days of the receipt of
deliverables and milestones to be
in the
Cinpathogen to successfully
entire study by the end of 2008.
the enhanced Quality Assurance/
Cinpathogen proposals of March 18,
and costs and the post
for the
explicitly recognized
of a contract with by the end of 2007 and the
should be consistent with to the partial laboratory transition task
findings should be
1. of hematopoietic and lymphoid set of controls from participating
consents and work history questionnaire for cases and controls will be accrued until June 30, 2007
neoplasms will be accrued until December 31 , 2007
2. assessment matrix for all study cases and controls. The matrix
industry and time period in developing exposure estimates to
benzene.
sources for exposure assessment including the IPHS data set, Yang
Pu database, the Chinese literature, real-time monitoring in selected factories and
simulations will be used to arrive at credible benzene exposure estimates.
3, A substantial preliminary data set (including AMLs and lymphoid neoplasms by WHO criteria, confounders and the exposure assessment matrix) for testing the casecontrol protocol to Applied Health Science by September 2007*. [No ICD-9 classifications are being delivered for the case-control study.]
1
SHELL-MCCLURG-061961
DRAFT CINPATHOGEN DELIVERABLES
4. A final data set (including all cases of AML and lymphoid neoplasms diagnosis during the study by WHO criteria, confounders and the exposure assessment matrix) for completion of the case-control protocol to Applied Health Sciences by June 2008*. [No ICD-9 classifications are being delivered for the case-control study.]
*Based on a timeline agreed upon in cooperation with the independent QA/QC team and Dr. Otto Wong.
Disease Progression Studies
1. Publication quality manuscript(s) presenting the protocol by November 1, 2008 following guidelines DPME proposal, Section 3.1-A.
Disease Progression March 18, 2007
Molecular Epidemiology Study
1. Publication quality manuscript(s) Epidemiology protocol by March 18, 2007 DPME proposal,
Project Management
1. Implementation of the Cinpathogen (Red Cavaney
2.
3.
2
SHELL-MCCLURG-061962