Pfizer Documents (PHMPT/FDA)
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· 147 pages
Page 1 of 147 ***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971025 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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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· 236 pages
Page 1 of 236 ***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971026 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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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· 320 pages
Page 1 of 320 ***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971031 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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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· 133 pages
Page 1 of 133 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421215 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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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· 141 pages
Page 1 of 141 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421247 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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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· 175 pages
Page 1 of 175 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421256 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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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· 204 pages
Page 1 of 204 ***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway Subject No: 10971087 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 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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· 885 pages
Page 1 of 885 ***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: 1098 Site Name: (1098) Salma Mazhar, MD, PA, Primary Care Clinic Subject No: 10981024 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:49 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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· 526 pages
Page 1 of 526 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421044 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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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· 181 pages
Page 1 of 181 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421073 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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)
· Pfizer Bla Submission
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· 153 pages
Page 1 of 153 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421084 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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)
· Pfizer Bla Submission
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· 129 pages
Page 1 of 129 ***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: 1142 Site Name: (1142) University of Texas - Galveston Subject No: 11421202 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:44 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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· 245 pages
FDA-CBER-2021-5683-1004652 FDA-CBER-2021-5683-1004653 FDA-CBER-2021-5683-1004654 FDA-CBER-2021-5683-1004655 FDA-CBER-2021-5683-1004656 FDA-CBER-2021-5683-1004657 FDA-CBER-2021-5683-1004658 FDA-CBER-2021-5683-1004659 FDA-CBER-2021-5683-1004660 FDA-CBER-2021-5683-1004661 FDA-CBER-2021-5683-1004662 FDA-CBER-2021-5683-1004663 FDA-CBER-2021-5683-1004664 FDA-CBER-2021-5683-1004665 FDA-CBER-2021-5683-1004666 FDA-CBER-2021-5683-1004667 FDA-CBER-2021-5683-1004668 FDA-CBER-2021-5683-1004669…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 266 pages
Page 1 of 266 ***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano Mayor Dr Cosme Argerich Subject No: 44441665 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:38 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 231 pages
Page 1 of 231 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin Subject No: 12031026 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
· Pfizer Bla Submission
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· 144 pages
Page 1 of 144 ***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai Subject No: 12041023 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
· Pfizer Bla Submission
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· 195 pages
Page 1 of 195 ***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai Subject No: 12041138 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
· Pfizer Bla Submission
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· 210 pages
Page 1 of 210 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai Subject No: 12041234 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
· Pfizer Bla Submission
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· 143 pages
Page 1 of 143 ***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: 1204 Site Name: (1204) Icahn School of Medicine at Mount Sinai Subject No: 12041280 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 127 pages
Page 1 of 127 ***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: 1205 Site Name: (1205) Hacettepe University Medical Faculty Subject No: 12051028 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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…