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To: 'Feldman@api.org' <Feldman@api.org> From: Cagen, Stuart Z SHLOIL-SHOIL-SHS </O=SHE LUOU=MSXSCC/CN=RE CI PI ENTS/CN=SC724012> Cc: whiter@api.org <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; 'Hargettb@api.org' <Hargettb@api.org>; 'Ng@api.org' <Ng@api.org>; 'Greco@api.org' <Greco@api.org> Bcc: Received Date: 2007-05-2702:50:47 GMT Subject: RE: latest version of deliverables All: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: ottowong@aol.com [mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. SH ELL-MCCLU RG-062099 The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com. Attachments: Cagen, Stuart Z SHLOIL-SHOIL-SHS.vcf SHELL-MCCLURG-062100 To: Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> From: Howard Feldman <Feldman@api.org> Cc: Russell White <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Bob Greco <Greco@api.org> Bcc: Received Date: 2007-05-2703:00:07 GMT Subject: Re: latest version of deliverables The data will be sent from Cinpathogen to Colorado and then from Colorado to AHS. So sending the data to AHS is not one of the Cinpathogen deliverables. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 22:50:45 2007 Subject: RE: latest version of deliverables All: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: ottowong@aol.com [mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. SHELL-MCCLURG-062101 Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com . SHELL-MCCLURG-062102 To: 'Howard Feldman' <Feldman@api.org> From: Cagen, Stuart Z SHLOIL-SHOIL-SHS </O=SHE LUOU=MSXSCC/CN=RE CI PI ENTS/CN=SC724012> Cc: Russell White <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Bob Greco <Greco@api.org> Bcc: Received Date: 2007-05-2703:02:19 GMT Subject: RE: latest version of deliverables Do we have a mechanism for Colorado deliverables ? Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26,20079:59 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables The data will be sent from Cinpathogen to Colorado and then from Colorado to AHS. So sending the data to AHS is not one of the Cinpathogen deliverables. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 22:50:45 2007 Subject: RE: latest version of deliverables All: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. SHELL-MCCLURG-062103 Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: ottowong@aol.com [ mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 SHELL-MCCLURG-062104 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com Attachments: Gagen, Stuart Z SHLOIL-SHOIL-SHS.vcf SHELL-MCCLURG-062105 To: Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> From: Howard Feldman <Feldman@api.org> Cc: Russell White <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Bob Greco <Greco@api.org> Bcc: Received Date: 2007-05-2703:08:21 GMT Subject: Re: latest version of deliverables transfer of the data to AHS is an explicit requirement of the Colorado grant extension. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 23:02:18 2007 Subject: RE: latest version of deliverables Do we have a mechanism for Colorado deliverables ? Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26,20079:59 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables The data will be sent from Cinpathogen to Colorado and then from Colorado to AHS. So sending the data to AHS is not one of the Cinpathogen deliverables. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 22:50:45 2007 Subject: RE: latest version of deliverables SHELL-MCCLURG-062106 AII: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: ottowong@aol.com [mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA SHELL-MCCLURG-062107 Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com SHELL-MCCLURG-062108 To: 'Howard Feldman' <Feldman@api.org> From: Cagen, Stuart Z SHLOIL-SHOIL-SHS </O=SHE LUOU=MSXSCC/CN=RE CI PI ENTS/CN=SC724012> Cc: Russell White <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Bob Greco <Greco@api.org> Bcc: Received Date: 2007-05-27 03: 18:23 GMT Subject: RE: latest version of deliverables Transfer of data to AHS without a sense of specificity as per Otto's concern, I suspect. Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26, 2007 10:08 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables transfer of the data to AHS is an explicit requirement of the Colorado grant extension. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 23:02:18 2007 Subject: RE: latest version of deliverables Do we have a mechanism for Colorado deliverables ? Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 SHELL-MCCLURG-062109 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26,20079:59 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables The data will be sent from Cinpathogen to Colorado and then from Colorado to AHS. So sending the data to AHS is not one of the Cinpathogen deliverables. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 22:50:45 2007 Subject: RE: latest version of deliverables All: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: ottowong@aol.com [ mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: SHELL-MCCLURG-062110 I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com . Attachments: Cagen, Stuart Z SHLOIL-SHOIL-SHS.vcf SHELL-MCCLURG-062111 To: Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> From: Howard Feldman <Feldman@api.org> Cc: Russell White <whiter@api.org>; Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Brenda Hargett <Hargettb@api.org>; Harry Ng <Ng@api.org>; Bob Greco <Greco@api.org> Bcc: Received Date: 2007-05-2703:34:03 GMT Subject: Re: latest version of deliverables True. We have been led to believe that the three way conversation between the investigators included discussions of how the data will look. I would encourage further interactions among the investigators to discuss and resolve any data issues. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 23:18:21 2007 Subject: RE: latest version of deliverables Transfer of data to AHS without a sense of specificity as per Otto's concern, I suspect. Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26, 2007 10:08 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables transfer of the data to AHS is an explicit requirement of the Colorado grant extension. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 23:02:18 2007 Subject: RE: latest version of deliverables Do we have a mechanism for Colorado deliverables ? SHELL-MCCLURG-062112 Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: Howard Feldman [mailto:Feldman@api.org] Sent: Saturday, May 26,20079:59 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: Russell White; Clegg, Patsy M SCC-DCS/22; Brenda Hargett; Harry Ng; Bob Greco Subject: Re: latest version of deliverables The data will be sent from Cinpathogen to Colorado and then from Colorado to AHS. So sending the data to AHS is not one of the Cinpathogen deliverables. ----- Original Message ----From: stuart.cagen@shell.com To: Howard Feldman Cc: Russell White; patsy.clegg@shell.com ; Brenda Hargett; Harry Ng; Bob Greco Sent: Sat May 26 22:50:45 2007 Subject: RE: latest version of deliverables All: Is it too late to do something about this? If Otto is concerned, we also should be concerned. It is unfortunate we did not have a chance to consult with him earlier. Stuart Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-1596 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com SHELL-MCCLURG-062113 -----Original Message----From: ottowong@aol.com [mailto:ottowong@aol.com] Sent: Friday, May 25,20076:55 PM To: Cagen, Stuart Z SHLOIL-SHOIL-SHS Cc: whiter@api.org; Clegg, Patsy M SCC-DCS/22; Jmricewas@aol.com Subject: latest version of deliverables Dear Stuart: I am glad that we got a chance to talk on the phone last night and you asked Russ White to send me the latest version of the deliverables of Cinpathogen. Russ sent me an earlier version of the deliverables some 3 or 4 weeks ago before I left for Shanghai and asked me to comment on them in connection with the CC study. I did and sent him my comments. I also talked to Rob Schnatter and Richard Irons on the phone about 2 weeks ago. Unfortunately many of my comments and our requirements are not in the latest version of the deliverables. Furthermore, it's unfortunately that I did not get a copy of the latest version of deliverables until this morning Shanghai time (Saturday). The latest version of deliverables for the CC study lacks details and specificity. AHS is not specified as one of the recipients of the test dataset or the final dataset. The general items, quality or status of the datasets is not specified. This means that there is no guarantee that the datasets will be ready for analysis or "user friendly." This may become a major issue later on. In terms of data validation, we need to have some assessment of the completeness or representativeness of the patients (cases and controls) included in the study. We discussed this before, but it is not included in the delive rabies. The latest deliverables are not consistent with previous comments or discussion and they do not satisfy the needs of the CC study. Regards, Otto ******* Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com AOL now offers free email to everyone. Find out more about what's free from AOL at AOL.com . SHELL-MCCLURG-062114 SHELL-MCCLURG-062115