Pfizer Documents (PHMPT/FDA)
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· 422 pages
Page 1 of 422 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1264 Site Name: (1264) University of California Davis Health Subject No: 12641229 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 254 pages
Page 1 of 254 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1264 Site Name: (1264) University of California Davis Health Subject No: 12641195 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…
Pfizer Documents (PHMPT/FDA)
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· 390 pages
Page 1 of 390 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1264 Site Name: (1264) University of California Davis Health Subject No: 12641133 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…
Pfizer Documents (PHMPT/FDA)
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· 184 pages
Page 1 of 184 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1261 Site Name: (1261) Benaroya Research Institute at Virginia Mason Subject No: 12611006 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 188 pages
Page 1 of 188 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601128 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 227 pages
Page 1 of 227 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601075 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 170 pages
Page 1 of 170 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601069 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 130 pages
Page 1 of 130 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601037 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 231 pages
Page 1 of 231 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601035 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 212 pages
Page 1 of 212 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1260 Site Name: (1260) UMass Memorial Medical Center Subject No: 12601018 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
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· 173 pages
Page 1 of 173 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1254 Site Name: (1254) Bayview Research Group Subject No: 12541189 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 161 pages
Page 1 of 161 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1254 Site Name: (1254) Bayview Research Group Subject No: 12541145 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 18:51 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 152 pages
Page 1 of 152 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1146 Site Name: (1146) Amici Clinical Research Subject No: 11461200 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:56 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
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· 182 pages
Page 1 of 182 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1112 Site Name: (1112) Clinical Research Atlanta Subject No: 11121118 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 191 pages
Page 1 of 191 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911300 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 176 pages
Page 1 of 176 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911299 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 449 pages
Page 1 of 449 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911297 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 157 pages
Page 1 of 157 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911274 Subject Initials: --- Generated By: Generated Time (GMT): 21-Apr-2021 18:02 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 170 pages
Page 1 of 170 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911247 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 134 pages
FDA-CBER-2021-5683-0789615 FDA-CBER-2021-5683-0789616 FDA-CBER-2021-5683-0789617 FDA-CBER-2021-5683-0789618 FDA-CBER-2021-5683-0789619 FDA-CBER-2021-5683-0789620 FDA-CBER-2021-5683-0789621 FDA-CBER-2021-5683-0789622 FDA-CBER-2021-5683-0789623 FDA-CBER-2021-5683-0789624 FDA-CBER-2021-5683-0789625 FDA-CBER-2021-5683-0789626 FDA-CBER-2021-5683-0789627 FDA-CBER-2021-5683-0789628 FDA-CBER-2021-5683-0789629 FDA-CBER-2021-5683-0789630 FDA-CBER-2021-5683-0789631 FDA-CBER-2021-5683-0789632…