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Page 1 of 241 ***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center Subject No: 11221053 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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…
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Page 1 of 118 ***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center Subject No: 11221051 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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,…
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Page 1 of 152 ***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: 1122 Site Name: (1122) Louis Stokes Cleveland VA Medical Center Subject No: 11221026 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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,…
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Page 1 of 160 ***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111193 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
Pfizer Documents (PHMPT/FDA)
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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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111139 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 138 ***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111130 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
Pfizer Documents (PHMPT/FDA)
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Page 1 of 229 ***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111109 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
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Page 1 of 906 ***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111103 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
Pfizer Documents (PHMPT/FDA)
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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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111099 Subject Initials: --- Generated By: Generated Time (GMT): 21-Apr-2021 18:02 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
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Page 1 of 205 ***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: 1111 Site Name: (1111) Fleming Island Center for Clinical Research Subject No: 11111095 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:58 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…
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16.2.5.3 Listing of Medication Errors – All Subjects ≥ 16 Years of Age Age Group (Years) Subject Dose No.a Start Date Type of Medication Error Action Taken Was a Concomitant Medication Given (Yes/No) Was the Nondrug Treatment Given (Yes/No) Stop Date Discontinued From Study (Yes/No) Medication Error– Associated AE (Yes/No) 16-55 C4591001 1011 10111215 1 19OCT2020 Product administration error DOSE NOT CHANGED N N 19OCT2020 N N C4591001 1012 10121103 2 22SEP2020…
Pfizer Documents (PHMPT/FDA)
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From: Gottschalk, Laura <[email protected]> Sent: Saturday, August 21, 2021 10:37 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Smith, Michael (CBER) <[email protected]>; Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]> Subject: STN 125742.0: 8th set of PI labeling comments - please respond by 3:00pm today Dear Elisa, Attached is the 8 th set…
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From: Smith, Michael (CBER) Sent: Saturday, August 21, 2021 10:33 AM To: Harkins Tull, Elisa <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Subject: RE: STN 125742.0: IR RE PMR's and PMC's Elisa, Sorry, be we had two minor revisions to our IR after I sent it. We revised the beginning of…
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FDA-CBER-2021-5683-1024862
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Saturday, August 21, 2021 2:18 PM To: Harkins Tull, Elisa <[email protected]> Cc: Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]>; Devlin, Carmel M <[email protected]>; Boyce, Donna <[email protected]> Subject: STN 125742/0 – COMIRNATY – CBER comments regarding label for identification of BLA lots and Dear HCP Letter Dear Ms. Harkins, Our…
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From: Smith, Michael (CBER) Sent: Tuesday, June 29, 2021 3:47 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Clinical IR RE Study C4591001 Elisa, The clinical team has the below IR regarding Study C4591001. The review team would prefer a…
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From: Gottschalk, Laura <[email protected]> Sent: Friday, August 20, 2021 1:51 PM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742/0 : 7th set of PI labeling comments and request for table with subjects who reported unsolicited AEs during…
Pfizer Documents (PHMPT/FDA)
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FDA-CBER-2021-5683-1024837
Pfizer Documents (PHMPT/FDA)
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FDA-CBER-2021-5683-1024836
Pfizer Documents (PHMPT/FDA)
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From: Naik, Ramachandra <[email protected]> Sent: Friday, August 20, 2021 2:23 PM To: Harkins Tull, Elisa <[email protected]> Cc: Rohlfing, Paul <[email protected]>; Aghajani Memar, Neda <[email protected]>; Boyce, Donna <[email protected]>; Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742/0 – COMIRNATY – CBER comments regarding label for identification of BLA lots…