125742 45 S211 M5 c4591001 interim ado audit certificates

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1Facsimile of Ori ginal Di gital Si gnatureTemplate Version: January 2021  Confidential Page 1of 3Pfizer Regulatory Quality Assurance
Audit Certificate
I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed.
Study C4591001 
Twenty-Two (22) investigator site  audits were performed between 29-A pr-2020 and 13-Mar-2021 for Study 
C4591001 Phase 2/3*.
Investigator Name Center 
NumberCountry Dates of AuditType of 
AuditName of Auditor 
Seger, William
Michael1042 United States 10 Aug 2020 to 13 Aug 2020 Routine Popelca, Bo gdan 
Rankin, Bruce Glenn 1109 United States 18 Aug 2020 to 21 Aug 2020 R outine Patel, Frederic
Zerbini, Cristiano
Augusto de Freitas1226 Brazil 24 Aug 2020 to 27 Aug 2020 Routine Tewes, Elisabeth
Polack, Fernando
Pedro1231 Argentina 27 Aug 2020 to 03 Sep 2020 Routine Mohr, Andrea 
Raad, George Louis 1079 Unite d States 01 Sep 2020 to 04 Sep 2020 R outine Jefferies, Maria
Arora, Samir 1091 United State s 14 Sep 2020 to 17 Sep 2020 Routine Samuels, Marilyn
Patel, Suchet R. 1077 United Sta tes 29 Sep 2020 to 02 Oct 2020 Routin e Tewes, Elisabeth
Fried, David L. 1124 United States 05 Oct 2020 to 07 Oct 2020 Non-
RoutineCutler, Robert 
Winkle, Peter John 1135 United States 12 Oct 2020 to 14 Oct 2020 Non-
RoutineCutler, Robert 
Polack, Fernando 
Pedro1231 Argentina 13 Oct 2020 to 20 Oct 2020 Non-
RoutineMohr, Andrea 
Reynolds, Steven H.  1149 Unite d States 16 Oct 2020 to 20 Oct 2020 Non-
RoutineCutler, Robert 
Rankin, Bruce Glenn 1109 Unite d States 19 Oct 2020 to 22 Oct 2020  Non-
RoutineOprisko, Cheryl 
Nell, Haylene 1247 South Africa  26 Oct 2020 to 29 Oct 2020 Routine  Tewes, Elisabeth
Koch, Mark 1128 Unite d States 03 Nov 2020 to 06 Nov 2020 Non-
RoutineCutler, Robert 
Schaefer, Axel 1195 Germany 16 Nov 2020 to 18 Nov 2020 Routine Aune r, Dagmar 
Williams, Hayes
Taylor1251 United States 16 Nov 2020 to 18 Nov 2020 Routine Oprisko, Cheryl 
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Template Version: January 2021  Confidential Page 2of 3Moreira Jr., Edson
Duarte1241 Brazil 24 Nov 2020 to 26 Nov 2020 Routine Mohr, Andrea 
Riesenberg, Robert
Alan1162 United States 30 Nov 2020 to 04 Dec 2020 Non-
RoutineTafurth, Maria
Finn, Daniel John 1016 United States 01 Dec 2020 to 03 Dec 2020 Ro utine Jefferies, Maria
Akhan, Sila 1217 Turkey 01 Dec 2020 to 03 Dec 2020 Routine Clayton, S imon
Jennings, Timothy
William1008 United States 07 Dec 2020 to 10 Dec  2020 Routine Samuels, Ma rilyn
Christensen, Shane
Glade1009 United States 01 Mar 2021 to 04 Mar  2021 Routine Jilla, Abil ash
*Sites audited as part  of Phase 1 are excluded
Approver:
Cecilia Gabarain 
Senior Director, Regulatory Quality Assurance 
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DocUUID : 95a005c3-cf51-4022-ad3d-c272ca1d93e5REASON: I approve
this document.REASON: I attest to theaccuracy and integrity ofthis document.
7997eefb-6feb-4dbc-a232-c15936633467
09 Apr 202109:40:016-0400
6809829b-f9ec-4ac9-bc23-e28cfba721dc
09 Apr 202115:40:007-0400
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MSB
Validation Report as of: 09 Apr 2021 15:44:008-0400
1
Subject CN TAIGLE LLC
Subject DN [email protected],CN=TAIGLE LLC,OU= MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=US
Email [email protected] # 19482482486555712400772614192179934953Issuer DN CN=Entrust Class 3 Client CA - SHA256,OU=(c) 2015 Entrust, Inc. - for authorized use only,OU=See www.entrust.net/legal-
terms,O=Entrust, Inc.,C=US
Signing Time 09 Apr 2021 15:40:007-0400
The Certificate chain was successfully built to a Trusted Root Certificate.
The Signer's identity is valid.
The Document has not been modified since the signature was appl ied.
This page was added to the original document by the MSB Validat ion Service (SVS) as part of the process to convert
active signature block content into inactive text. A full validation report of each signature is generated and cross-
referenced using a numeric footnote annotation.
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Audit Trail Report
Date User Document Action Details
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