Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411117 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 326 pages
Page 1 of 326 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411197 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 187 pages
Page 1 of 187 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411206 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 270 pages
Page 1 of 270 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411208 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 303 pages
Page 1 of 303 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411269 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 294 pages
Page 1 of 294 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411279 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411343 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 248 pages
FDA-CBER-2021-5683-0993976 FDA-CBER-2021-5683-0993977 FDA-CBER-2021-5683-0993978 FDA-CBER-2021-5683-0993979 FDA-CBER-2021-5683-0993980 FDA-CBER-2021-5683-0993981 FDA-CBER-2021-5683-0993982 FDA-CBER-2021-5683-0993983 FDA-CBER-2021-5683-0993984 FDA-CBER-2021-5683-0993985 FDA-CBER-2021-5683-0993986 FDA-CBER-2021-5683-0993987 FDA-CBER-2021-5683-0993988 FDA-CBER-2021-5683-0993989 FDA-CBER-2021-5683-0993990 FDA-CBER-2021-5683-0993991 FDA-CBER-2021-5683-0993992 FDA-CBER-2021-5683-0993993…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411385 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 300 pages
Page 1 of 300 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411410 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 219 pages
Page 1 of 219 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411468 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 217 pages
Page 1 of 217 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411471 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 261 pages
Page 1 of 261 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411493 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
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· 252 pages
Page 1 of 252 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411514 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 299 pages
Page 1 of 299 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411561 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411568 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411643 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 159 pages
Page 1 of 159 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411679 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
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: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411766 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 159 pages
Page 1 of 159 ***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: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411825 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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…