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2373 documents

125742 S1 M5 CRF c4591001 1013 10131718

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 428 pages

Page 1 of 428 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131718 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1015 10151101

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 133 pages

Page 1 of 133 ***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: 1015 Site Name: (1015) Boston Medical Center Subject No: 10151101 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131658

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 122 pages

Page 1 of 122 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131658 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131656

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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131656 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131653

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 176 pages

Page 1 of 176 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131653 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131554

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 463 pages

Page 1 of 463 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131554 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131517

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 144 pages

Page 1 of 144 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131517 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131255

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 204 pages

Page 1 of 204 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131255 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131386

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 117 pages

Page 1 of 117 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131386 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131229

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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131229 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131699

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: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131699 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131176

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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131176 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131165

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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131165 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131089

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 225 pages

Page 1 of 225 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131089 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1013 10131084

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 179 pages

Page 1 of 179 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131084 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1012 10121112

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 246 pages

Page 1 of 246 ***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: 1012 Site Name: (1012) HOPE Research Institute Subject No: 10121112 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…

125742 S1 M5 CRF c4591001 1012 10121163

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 225 pages

Page 1 of 225 ***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: 1012 Site Name: (1012) HOPE Research Institute Subject No: 10121163 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…

125742 S1 M5 CRF c4591001 1011 10111181

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: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC Subject No: 10111181 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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 1012 10121097

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 286 pages

Page 1 of 286 ***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: 1012 Site Name: (1012) HOPE Research Institute Subject No: 10121097 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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…

125742 S1 M5 CRF c4591001 1013 10131190

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 431 pages

Page 1 of 431 ***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc. Subject No: 10131190 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…