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: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261775 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 222 pages
Page 1 of 222 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261769 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 186 pages
Page 1 of 186 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261745 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 196 pages
Page 1 of 196 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261714 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261713 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 215 pages
Page 1 of 215 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261707 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 445 pages
Page 1 of 445 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261624 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 409 pages
Page 1 of 409 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261599 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 202 pages
Page 1 of 202 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261583 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261571 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 236 pages
Page 1 of 236 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261545 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261477 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 256 pages
Page 1 of 256 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261432 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 206 pages
Page 1 of 206 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261417 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 310 pages
Page 1 of 310 ***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: 1226 Site Name: (1226) CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda Subject No: 12261338 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:54 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 128 pages
Page 1 of 128 ***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: 1251 Site Name: (1251) Achieve Clinical Research Subject No: 12511031 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 330 pages
Page 1 of 330 ***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: 1251 Site Name: (1251) Achieve Clinical Research Subject No: 12511029 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 130 pages
Page 1 of 130 ***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center Subject No: 12481218 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…
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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center Subject No: 12481163 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 278 pages
Page 1 of 278 ***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center Subject No: 12481120 Subject Initials: --- Generated By: Generated Time (GMT): 04-May-2021 12:42 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…