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2373 documents

125742 S1 M5 CRF c4591001 1152 11521222

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521222 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…

125742 S1 M5 CRF c4591001 1152 11521095

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 582 pages

Page 1 of 582 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521095 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…

125742 S1 M5 CRF c4591001 1152 11521085

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 124 pages

Page 1 of 124 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521085 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…

125742 S1 M5 CRF c4591001 1152 11521053

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 178 pages

Page 1 of 178 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521053 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…

125742 S1 M5 CRF c4591001 1141 11411270

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 205 pages

Page 1 of 205 ***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411270 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…

125742 S1 M5 CRF c4591001 1141 11411230

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411230 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,…

125742 S1 M5 CRF c4591001 1141 11411221

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 233 pages

Page 1 of 233 ***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411221 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,…

125742 S1 M5 CRF c4591001 1141 11411153

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 280 pages

Page 1 of 280 ***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411153 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,…

125742 S1 M5 CRF c4591001 1141 11411143

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 165 pages

Page 1 of 165 ***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411143 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,…

125742 S1 M5 CRF c4591001 1131 11311100

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 412 pages

Page 1 of 412 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311100 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1131 11311095

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 416 pages

Page 1 of 416 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311095 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1131 11311094

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 222 pages

Page 1 of 222 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311094 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1131 11311067

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 396 pages

Page 1 of 396 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311067 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1092 10921120

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 284 pages

Page 1 of 284 ***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: 1092 Site Name: (1092) Sterling Research Group, Ltd. Subject No: 10921120 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…

125742 S1 M5 CRF c4591001 1027 10271191

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 637 pages

Page 1 of 637 ***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: 1027 Site Name: (1027) PharmQuest Subject No: 10271191 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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 option is equivalent…

125742 S1 M5 CRF c4591001 1141 11411140

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 209 pages

Page 1 of 209 ***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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411140 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,…

125742 S1 M5 CRF c4591001 1141 11411113

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1141 Site Name: (1141) University of Iowa Hospital and Clinics Subject No: 11411113 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,…

125742 S1 M5 CRF c4591001 1135 11351563

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 169 pages

Page 1 of 169 ***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: 1135 Site Name: (1135) Anaheim Clinical Trials Subject No: 11351563 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1135 11351434

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 138 pages

Page 1 of 138 ***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: 1135 Site Name: (1135) Anaheim Clinical Trials Subject No: 11351434 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…

125742 S1 M5 CRF c4591001 1135 11351368

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 271 pages

Page 1 of 271 ***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: 1135 Site Name: (1135) Anaheim Clinical Trials Subject No: 11351368 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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…