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2373 documents

125742 S1 M5 CRF c4591001 1134 11341174

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 213 pages

Page 1 of 213 ***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: 1134 Site Name: (1134) PMG Research of Winston-Salem Subject No: 11341174 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…

125742 S1 M5 CRF c4591001 1134 11341153

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 297 pages

Page 1 of 297 ***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: 1134 Site Name: (1134) PMG Research of Winston-Salem Subject No: 11341153 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…

125742 S1 M5 CRF c4591001 1134 11341085

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: 1134 Site Name: (1134) PMG Research of Winston-Salem Subject No: 11341085 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…

125742 S1 M5 CRF c4591001 1134 11341058

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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem Subject No: 11341058 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…

125742 S1 M5 CRF c4591001 1134 11341019

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 185 pages

Page 1 of 185 ***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: 1134 Site Name: (1134) PMG Research of Winston-Salem Subject No: 11341019 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…

125742 S1 M5 CRF c4591001 1133 11331640

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: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1133 Site Name: (1133) QPS-MRA, LLC Subject No: 11331640 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 equivalent to…

125742 S1 M5 CRF c4591001 1133 11331537

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 215 pages

Page 1 of 215 ***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: 1133 Site Name: (1133) QPS-MRA, LLC Subject No: 11331537 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 equivalent to…

125742 S1 M5 CRF c4591001 1133 11331317

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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1133 Site Name: (1133) QPS-MRA, LLC Subject No: 11331317 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 equivalent…

125742 S1 M5 CRF c4591001 1178 11781073

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 139 pages

Page 1 of 139 ***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: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781073 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1178 11781061

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 472 pages

Page 1 of 472 ***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: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781061 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1178 11781048

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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781048 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1178 11781025

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: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781025 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1178 11781015

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 171 pages

Page 1 of 171 ***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: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781015 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1178 11781012

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 142 pages

Page 1 of 142 ***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: 1178 Site Name: (1178) Clinical Research Associates Inc Subject No: 11781012 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 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 1174 11741042

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 200 pages

Page 1 of 200 ***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious Diseases, LLC CARE-ID Subject No: 11741042 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 12:55 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from…

125742 S1 M5 CRF c4591001 1270 12701142

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 131 pages

Page 1 of 131 ***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento Subject No: 12701142 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…

125742 S1 M5 CRF c4591001 1270 12701069

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: 1270 Site Name: (1270) Kaiser Permanente Sacramento Subject No: 12701069 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…

125742 S1 M5 CRF c4591001 1270 12701057

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 720 pages

Page 1 of 720 ***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento Subject No: 12701057 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…

125742 S1 M5 CRF c4591001 1265 12651149

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 155 pages

Page 1 of 155 ***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: 1265 Site Name: (1265) Kaiser Permanente Subject No: 12651149 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…

125742 S1 M5 CRF c4591001 1265 12651101

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 331 pages

Page 1 of 331 ***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: 1265 Site Name: (1265) Kaiser Permanente Subject No: 12651101 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…