Document 4azQo5mne8k47r8MNw0QZnOZp
From: Sent: To:
Subject:
Attach:
Russell White <whiter@api.org>
Friday, June 22,20078:35 PM (GMT)
BenzConsort-OC@listserve.api.org; BenzConsort-TC@listserve.api.org; BHRC Communications Committee <benzconsort-cc@listserve.api.org>
FW: Shanghai Health Study - More materials for the conference call on Monday, June 25 at 1 PM EDT
Letter from FU Hua to Bruce Jarnot - CC study proposa1.doc; Fudan CC study contract 2007 & 2008.xls; fu hua.pdf; Cinpathogen 2007-102814 Appendix B Milestones 5-2107.doc
I'm forwarding the materials we received from Dr. Fu Hua this week plus the final list of deliverables included in the Cinpathogen contract. They will be discussed on Monday's conference call.
From: hfu [mailto:hfu@shmu.edu.cn] Sent: Tuesday, June 19, 2007 11:04 AM To: Bruce Jarnot Cc: Russell White; Bruce Jarnot; ottowong Subject: Re: Shanghai Health Study... API fax number (resend)
Dear Bruce I am sorry to delay my reponse for the case control study. Currently Otto and I worked to prepare rest of the project work and budget. Herewith pIs find the attachment of my confirm letter, budget and the a letter from our Dean. If you have any question, pIs dont hesitate to contact to me.
~~~~~~~~~~~
53: fti.8email .f:-fu.f:ll:r&j;Jhfu@fudan.edu.cn.l2J.J~~iwfflif.lT.f:-fu.f:ll:. i.~ji.~j!
Ps:My email address has been changed into hfu@fudan.edu.cn, please use this new email address to contact to me. Thanks!
BestRegards
FuHua ff1' *************************
Fu Hua, MB, MPH,PhD Deputy Dean and Professor School of Public Health Fudan University Box 248, 138 Yixueyuan Road Shanghai 200032 Te1.:86-2l-54237202 Fax.:86-2l-54237058
======== 2006-09-11 19: 49: 20 1~fr*fr:p ~jj[:
Dear Dr. Fu ?o:p>
Apologies if my previous email failed to reach you?please send copies of your scanned receipts to our API fax number, which is 202-682-8031.
SH ELL-MCCLU RG-053781
Best Regards? Bruce.
From: Bruce Jarnot Sent: Friday, September 08,20068:57 AM To: 'Hua Fu' Cc: Russell White Subject: API Fax# (202) 682-8031... RE: invoice-2005
Dear Professor Fu ?o:p>
It was very nice to hear from you, and we look forward to receiving your faxBPlease send these pages to: 202-682-8031.
Thank you, and with
Best Regards? Bruce.
From: Fu Hua [mailto:hfu@shmu.edu.cn] Sent: Friday, September 08, 2006 11 :35 PM To: Bruce Jarnot Cc: Russell White Subject: ~1!: Shanghai Health Study... publications to date?
Dear Drs. White and Jarnot I am sending you the 2005 invoice and some copies of the receipts again. I scanned the receipts, but they are too big to be sent by email. Would you pis tell me your fax number? I will sent them by fax. As I should wait for university new semester and copy some receipts I am sorry delay to send the documents to you until now. I would grateful if you would tell me your comments and give me an acknowledgement when receiving this email.
Bese regards FuHua
SH ELL-MCCLU RG-053782
**************************
Fu Hua, MB, MPH, PhD Deputy Dean and Professor School of Public Health Fudan University PO Box 248 138 Yixueyuan Road Shanghai 200032 PR China Fax: 86-21-64223464 Tel: 86-21-54237202
1Z{~)\: Bruce Jarnot [mailto:jarnotb@api.org]
1Z:i!ll1r8J: 2006~8 Jj 25 B 1: 42
~{~)\: Richard. Irons@UCHSC.edu; OttoWong@aol.com; Fu Hua
fY:i!: Jmricewas@aol.com; thomas.w.armstrong@exxonmobil.com; a.r. schnatter@exxonmobil.com; Russell White
3t~: Shanghai Health Study... publications to date? ]t~,ti: r'a:J
Shanghai Health Study Pit!. (Drs. Fu, Irons, & Wong) ?/SPAN> The Consortium has asked API to update its list of SHS publications?
Articles published to date (Citations? Reprints?) 1. Irons RD, Lv L, Gross SA, Ye X, Bao L, Wang XQ, Ryder J, Armstrong TW, Zhou Y, Miao L, Le AT,
Kerzic PJ, Ni W, and Fu H (2005) Chronic exposure to benzene results in a unique form of dysplasia. Leukemia Research 29, 1371-80. (Reprints were received)
2. ?
3. ?
SH ELL-MCCLU RG-053783
Abstracts published to date (Citations?) 1. Gross SA, Wang X, Ryder J, Zhu XZ, Bao L, Fu H and Irons RD (2005) Lymphoid neoplasms in
Shanghai China: Relative Frequency of subtypes of NHL diagnosed according to the WHO classification. Abstract #5364, Proceedings on/SPAN>
2. ?
Accepted, but not yet published (Journal?)
1. ?
Thank you - Bruce.
I~
SH ELL-MCCLU RG-053784
SH ELL-MCCLU RG-053785
CINPATHOGEN CONTRACT MILESTONES -- MAY 21,2007
Appendix B
This document spells out the expectations of API and the Study sponsors with regard to the contract for supplemental funding to Cinpathogen for completion of the Shanghai Health Study. Consistent with the original scope of work for the Study and grant, the design, performance and conclusions of the Study are in the sole control of the principal investigators. The milestones laid out in this document are not intended to change that, or in any way to request or require divulgence of data or interim results to the sponsors or API prior to acceptance of manuscripts for publication in scientific journals. The purpose of requesting the milestone reporting set forth herein is for the sole purpose of allowing API and the Study Sponsors Oversight Committee to fulfill their obligations to monitor costs and the progress of the study, with numbers of cases reported and other factors used as benchmarks of study progress.
1. Short-term milestones to be achieved in the second quarter, 2007. a. In May 2007, provide an update of the numbers of AML and NHL1 cases that can be used in the case-control study. b. Reestablish case accrual at participating Shanghai Hospitals i. Within the new administrative structure, provide arrangements for continued review of original work history questionnaires by Dr. Otto Wong and his associates.2 c. Continue necessary exposure assessment activities for completion of the jobexposure matrix i. Complete Chinese literature reviews and simulation studies of key tasks by end of 2007. ii. Complete methods comparison to assess potential inaccuracies in IPHS database exposure values by end of 2007. iii. Complete monitoring campaigns as part of ME study by end of 2007. iv. Provide quarterly reports on progress of above tasks to QA team (ongoing).
d. Cooperate with the independent QA/QC team to fulfill the elements of the QA/QC team charter.
2. Long-term milestones to complete the case accrual work by the end of 2007 and the entire study by the end of 2008. a. Provide preliminary data and case counts i. Provide to the University of Colorado or its designee as soon as feasible with an outside goal of mid-September 2007, a substantial but preliminary data set consisting of provisional or final diagnoses for AMLs and NHLs (depending on their status at the time of data migration) for which ICs are documented, and their matched controls, all questionnaire information and yes/no as well as categorical exposure information, if known. ii. Provide an update of the numbers of cases that can be used in the casecontrol study in September, 2007. iii. Provide an update of the numbers of cases that can be used in the casecontrol study in January, 2008.
1 Defined here as the WHO classification for lymphoid neoplasms. Jaffe ES, Harris NL, Stein H, et at.
Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues. Lyon, France, IARC Press, 2001. 2 In cooperation with the independent QA/QC team.
1
SH ELL-MCCLU RG-053786
CINPATHOGEN CONTRACT MILESTONES -- MAY 21,2007
Appendix B
b. Provide to the University of Colorado or its designee by the end of June, 2008 a final data set consisting of all diagnosed and verified AMLs and NHLs and their matched controls, including subtype diagnostic classifications according to the WH01, and all questionnaire information for completion of the case-control protocol.
c. Complete case accrual for AML by June 30,2007, and NHL by December 31, 2007, that meet selection criteria previously outlined in previous proposals, most recently, the March 18th, 2007 proposal. It is understood that this includes a matched set of controls (2X), together with documentation of informed consents.
d. Complete strategy for combining EA sources for development of job exposure matrix by end of February, 2008. Complete job exposure matrix for assignment of exposures to cases and controls by end of May, 2008. Provide results of job exposure matrix and links to study subjects by the end of June, 2008. Include the latter in the final data set.
e. By November 1, 2008, submit for publication to appropriate scientific journals manuscript(s) presenting the findings of the DP protocol following the guidelines of the March 18th , 2007 DPME and previous proposals.
f. By November 1, 2008, submit for publication to appropriate scientific journals manuscript(s) presenting the findings of the ME study following the guidelines of the March 18th , 2007 DPME and previous proposals.
g. Implement the recommendations of the independent QA/QC team. h. Provide semi-annual progress reports to the SRP and ERP panelists, SHS
sponsors and API. Included in the progress reports, in order to avoid divulgence of data or interim results, the update to SHS sponsors and API should only include a list of manuscripts actually published or accepted for publication.
2
SH ELL-MCCLU RG-053787
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,....
FudZ:ln Univer:~ity
SH ELL-MCCLU RG-053788
AI
1 Fudan University School of Public Health 2 Case-control study budget (in US$)
3 4 Labor 5 Category 6 Physician epidemiologist (PI) 7 Administrative assistant 8 Research assistant 9 Total labor (in 2004 US$) 10 11 Expenses 12 Office supplies 13 Transportation 14 Communication & phone calls 15 Total expenses (in 2004 US$) 16 17 Subtotal of labor and expenses (in 2004 US$) 18 19 Annual adjustments and overhead fee 20 Subtotal with 5% annual adjustment 21 University overhead fee (15%) 22 GRAND TOTAL 23 24 *Previously approved annual salaries, which include base salaries, bonuses and benefits (in 2004 dollars).
BI
Annual salary* 16,900 5,850 5,850
c
Time 0.25 0.10 2.00
D IE
2007 Amount
4,225 585
11,700 16,510
Time 0.35 0.10 2.00
Amount 1,000 2,000 2,000 5,000
21,510
24,901 3,735
28,636
FIG
2008 Amount
5,915 585
11,700 18,200
Total Amount
10,140 1,170
23,400 34,710
Amount 1,000 2,000 2,000 5,000
Total 2,000 4,000 4,000 10,000
23,200 44,710
28,200 7,710
35,910
53,100 11,445 64,545
SH ELL-MCCLU RG-053789
Dear Dr. Jamot:
After talking to Dr. Otto Wong last week and this week, I have agreed to continue to assist him in the case-control study of AML and NHL. Dr. Wong and I have agreed on the following two major items:
(l) I will continue as a Principal Investigator of the case-control study.
(2) My group at the School of Public Health (administrative assistant and research assistants) will assist Dr. Wong in the following activities:
Monitoring of patient accrual (2007). Monitoring of patient interviews (2007 and 2008). Assist Dr. Wong in QAlQC when he works in Shanghai (2007 and 2008). Literature review of risk factors of AML and NHL (2007). Data management and analysis (2008). Report preparation (2008). Manuscript preparation (2008).
Attached please find our budget estimate for 2007 and 2008. Payments are to be made on a semi-annual basis (50% of the 2007 budget on 30 June 2007 and the remaining 50% on 31 December 2007,50% of the 2008 budget on 30 June 2008 and the remaining 50% on 31 December 2008). Also attached is a letter from Dr. Jiang Qingwu, Dean of School of Public Health, Fudan University, reaffirming my role in the Shanghai Health Study.
To avoid any disruption of Dr. Wong's work in the case-control study, we have been providing assistance to him without a contract or funding. However, we will not be able to do so for much longer without a formal contract and proper funding. Therefore, I would appreciate it very much if you could reach a decision on our proposal by the end of June 2007.
If you have any questions regarding this proposal, please do not hesitate to contact me.
Sincerely,
FU Hua, Ph.D., MB Deputy Dean and Professor School of Public Health Fudan University
SH ELL-MCCLU RG-053790