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2373 documents

125742 S1 M5 CRF c4591001 1109 11091415

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 265 pages

Page 1 of 265 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091415 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…

125742 S1 M5 CRF c4591001 1109 11091448

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 343 pages

Page 1 of 343 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091448 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…

125742 S1 M5 CRF c4591001 1109 11091503

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091503 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…

125742 S1 M5 CRF c4591001 1109 11091558

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 197 pages

Page 1 of 197 ***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit Subject No: 11091558 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…

125742 S1 M5 CRF c4591001 1116 11161045

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 329 pages

Page 1 of 329 ***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: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161045 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 is…

125742 S1 M5 CRF c4591001 1116 11161059

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: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161059 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 is…

125742 S1 M5 CRF c4591001 1116 11161131

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161131 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 is…

125742 S1 M5 CRF c4591001 1116 11161160

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 343 pages

Page 1 of 343 ***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: 1116 Site Name: (1116) MedPharmics, LLC Subject No: 11161160 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 is…

125742 S1 M5 CRF c4591001 1171 11711023

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 211 pages

Page 1 of 211 ***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: 1171 Site Name: (1171) Martin Diagnostic Clinic Subject No: 11711023 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 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 1170 11701217

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 507 pages

Page 1 of 507 ***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A. Subject No: 11701217 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 S1 M5 CRF c4591001 1170 11701121

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A. Subject No: 11701121 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 S1 M5 CRF c4591001 1170 11701090

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 207 pages

Page 1 of 207 ***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A. Subject No: 11701090 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 S1 M5 CRF c4591001 1170 11701013

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 146 pages

Page 1 of 146 ***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A. Subject No: 11701013 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:23 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…

125742 S1 M5 CRF c4591001 1152 11521551

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 203 pages

Page 1 of 203 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521551 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…

125742 S1 M5 CRF c4591001 1152 11521497

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 150 pages

Page 1 of 150 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521497 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 11521476

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 208 pages

Page 1 of 208 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521476 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 11521450

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 143 pages

Page 1 of 143 ***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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521450 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 11521411

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 143 pages

Page 1 of 143 ***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: 11521411 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 11521316

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 224 pages

Page 1 of 224 ***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: 11521316 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 11521260

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1152 Site Name: (1152) California Research Foundation Subject No: 11521260 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…