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2373 documents

125742 S1 M5 CRF c4591001 1016 10161042

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 433 pages

Page 1 of 433 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161042 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…

125742 S1 M5 CRF c4591001 1169 11691056

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 305 pages

Page 1 of 305 ***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: 1169 Site Name: (1169) Lehigh Valley Hospital Subject No: 11691056 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 is…

125742 S1 M5 CRF c4591001 1169 11691055

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 160 pages

Page 1 of 160 ***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: 1169 Site Name: (1169) Lehigh Valley Hospital Subject No: 11691055 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 is…

125742 S1 M5 CRF c4591001 1169 11691010

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 149 pages

Page 1 of 149 ***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: 1169 Site Name: (1169) Lehigh Valley Hospital Subject No: 11691010 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 is…

125742 S1 M5 CRF c4591001 1168 11681225

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 187 pages

Page 1 of 187 ***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: 1168 Site Name: (1168) Lynn Health Science Institute Subject No: 11681225 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…

125742 S1 M5 CRF c4591001 1168 11681083

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: 1168 Site Name: (1168) Lynn Health Science Institute Subject No: 11681083 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…

125742 S1 M5 CRF c4591001 1167 11671175

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: 1167 Site Name: (1167) Holston Medical Group Subject No: 11671175 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 is…

125742 S1 M5 CRF c4591001 1167 11671085

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 192 pages

Page 1 of 192 ***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: 1167 Site Name: (1167) Holston Medical Group Subject No: 11671085 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 is…

125742 S1 M5 CRF c4591001 1167 11671077

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: 1167 Site Name: (1167) Holston Medical Group Subject No: 11671077 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 is…

125742 S1 M5 CRF c4591001 1167 11671069

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1167 Site Name: (1167) Holston Medical Group Subject No: 11671069 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 is…

125742 S1 M5 CRF c4591001 1167 11671009

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 387 pages

Page 1 of 387 ***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: 1167 Site Name: (1167) Holston Medical Group Subject No: 11671009 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 is…

125742 S1 M5 CRF c4591001 1150 11501153

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 180 pages

Page 1 of 180 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501153 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 equivalent…

125742 S1 M5 CRF c4591001 1150 11501093

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 210 pages

Page 1 of 210 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501093 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 1150 11501084

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 311 pages

Page 1 of 311 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501084 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 1150 11501069

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 148 pages

Page 1 of 148 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501069 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 1150 11501037

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 168 pages

Page 1 of 168 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501037 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 1150 11501022

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 214 pages

Page 1 of 214 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501022 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 1150 11501001

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501001 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 1149 11491313

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 334 pages

Page 1 of 334 ***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC. Subject No: 11491313 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,…

125742 S1 M5 CRF c4591001 1149 11491239

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: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC. Subject No: 11491239 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,…