Pfizer Documents (PHMPT/FDA)
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Page 1 of 202 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051387 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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,…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 334 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051293 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
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Page 1 of 180 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051347 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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,…
Pfizer Documents (PHMPT/FDA)
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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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051214 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 212 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051054 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 193 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051069 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 457 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 19-May-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031038 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 313 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1001 Site Name: (1001) NYU Langone Health Subject No: 10011100 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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…
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Page 1 of 174 ***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: 1001 Site Name: (1001) NYU Langone Health Subject No: 10011135 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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…
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Page 1 of 424 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1001 Site Name: (1001) NYU Langone Health Subject No: 10011093 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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…
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Page 1 of 164 ***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051047 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
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Page 1 of 170 ***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031197 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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· 174 pages
Page 1 of 174 ***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031207 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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· 473 pages
Page 1 of 473 ***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031186 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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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: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031149 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 409 pages
Page 1 of 409 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031113 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 202 pages
Page 1 of 202 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031111 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 407 pages
Page 1 of 407 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General Hospital Subject No: 10031065 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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Category Date T me PID Protoco Vers on Was the subject re screened? A prev ous TSNs (e.g. 276 0 234) Date of f rst Informed ConsentInformed Consent (2.1) No YesBioNTech BNT162 01 CRS 049 20 DEV CRS Study Code: 049/20 Sponsor Study Code: BNT162-01 22/04/2020 Blank eCRF (CTP 3.0) DS=Disposition DM=Demographics DSCAT='PROTOCOL MILESTONE' DSSTDTC Page 1 SUPPDS.QVAL when QNAM = 'PREV_TSN' DSSTDTC SUPPDS.QVAL when QNAM = 'PROTVERS' [NOT SUBMITTED] RFICDTC DSTERM/DSDECOD='INFORMED CONSENT…
Pfizer Documents (PHMPT/FDA)
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Analysis Data Reviewer’s Guide Pfizer Inc. BioNTech SE Study BNT162-01 This document contains confidential information belonging to Pfizer Inc. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor to use it for un- authorized purposes. In the event of actual or suspected breach of this obligation, Pfizer…