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2373 documents

125742 S1 M5 CRF c4591001 1095 10951206

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: 1095 Site Name: (1095) Tekton Research Subject No: 10951206 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, STAGE 3 option is…

125742 S1 M5 CRF c4591001 1231 12314128

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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314128 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314091

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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314091 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314075

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 267 pages

Page 1 of 267 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314075 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314059

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 172 pages

Page 1 of 172 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314059 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314041

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 134 pages

Page 1 of 134 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314041 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314035

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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314035 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314033

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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314033 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314001

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 317 pages

Page 1 of 317 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314001 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12313998

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 276 pages

Page 1 of 276 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12313998 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12313972

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 166 pages

Page 1 of 166 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12313972 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12313894

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 188 pages

Page 1 of 188 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12313894 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12313884

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 198 pages

Page 1 of 198 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12313884 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12313879

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 263 pages

Page 1 of 263 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12313879 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1247 12471244

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: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471244 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…

125742 S1 M5 CRF c4591001 1247 12471226

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 223 pages

Page 1 of 223 ***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471226 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…

125742 S1 M5 CRF c4591001 1247 12471220

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 425 pages

Page 1 of 425 ***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471220 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…

125742 S1 M5 CRF c4591001 1247 12471172

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471172 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…

125742 S1 M5 CRF c4591001 1247 12471137

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 257 pages

Page 1 of 257 ***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471137 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…

125742 S1 M5 CRF c4591001 1247 12471135

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 328 pages

Page 1 of 328 ***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: 1247 Site Name: (1247) Tiervlei Trial Centre-Karl Bremer Hospital Subject No: 12471135 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…