Document text
1Facsimile of Original Digital SignatureTemplate Version: 26-Sep-2014 Confidential Page 1of 2Pfizer Regulatory Quality Assurance
Audit Certificate
I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed.
Study C4591001
Sixteen (16) investigator site audits were performed between 29-Apr- 2020 and 14-Nov-2020 for Study C4591001
Phase 2/3*.
Investigator Name Center
NumberCountry Dates of AuditType of
AuditName of Auditor
Mulligan, Mark Joseph 1001 United States 27 Jul 2020 to 30 Jul 2020 Routine Jefferies, Maria
Neuzil, Kathleen
Maletic1002 United States 10 Aug 2020 to 13 A ug 2020 Routine Cutler, Rob ert
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 Rou tine 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 States 14 Sep 2020 to 17 Sep 2020 Routine Sa muels, Marilyn
Patel, Suchet R. 1077 United Sta tes 29 Sep 2020 to 02 Oct 2020 Routine 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
DocUUID : dd1d3c42-4215-4faf-843f-b1d1d2d5c436 Page 1
090177e195a22bb6\Approved\Approved On: 03-Dec-2020 07:03 (GMT)
FDA-CBER-2021-5683-0029190
Template Version: 26-Sep-2014 Confidential Page 2of 2*Site 1001 and 1002 audited as part of Phase 1
Approver:
Cecilia Gabarain
Senior Director, Regulatory Quality Assurance
DocUUID : dd1d3c42-4215-4faf-843f-b1d1d2d5c436REASON: I approve
this document.REASON: I attest to theaccuracy and integrity ofthis document.
7997eefb-6feb-4dbc-a232-c15936633467
19 Nov 202013:28:049-0500
6809829b-f9ec-4ac9-bc23-e28cfba721dc
20 Nov 202010:12:039-0500
Page 2
090177e195a22bb6\Approved\Approved On: 03-Dec-2020 07:03 (GMT)
FDA-CBER-2021-5683-0029191
MSB
Validation Report as of: 20 Nov 2020 10:14:010-0500
1
Subject CN MSB
Subject DN [email protected],CN=MSB,OU=MSB,O=TAIGLE LLC,L=Irvine,ST=California,C=USEmail [email protected] # 103155442024134641897105422308128156249Issuer 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 20 Nov 2020 10:12:039-0500
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.
DocUUID : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
Page 3
090177e195a22bb6\Approved\Approved On: 03-Dec-2020 07:03 (GMT)
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Audit Trail Report
Date User Document Action Details
DocUUID : dd1d3c42-4215-4faf-843f-b1d1d2d5c43619 Nov 2020 13 09:007-0500 Christine Mina Started The custodian composed the ePak succesfully.
User UU D : a3b2e181-3aee-4aea-b101-ec31853d0033
User Email : christine [email protected]
19 Nov 2020 13 09:007-0500 Robert N Cutler RequestSent Sign request sent to ePak recipient.
User UUID : 7997eefb-6feb-4dbc-a232-c15936633467
User Email : robert cutler@pfizer com
19 Nov 2020 13 27:054-0500 Robert N Cutler C4591001 Phase 2_3 Aud it
Cert 19-Nov-2020.pdfDocumentViewed Document viewed by signer.
User UUID : 7997eefb-6feb-4dbc-a232-c15936633467
User Email : robert cutler@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
19 Nov 2020 13 28:050-0500 Robert N Cutler C4591001 Phase 2_3 Aud it
Cert 19-Nov-2020.pdfSignerTagFilled The signer filled Time Stamp.
Value: 19 Nov 2020 13 28:049-0500
User UUID : 7997eefb-6feb-4dbc-a232-c15936633467
User Email : robert cutler@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
19 Nov 2020 13 28:050-0500 Robert N Cutler C4591001 Phase 2_3 Aud it
Cert 19-Nov-2020.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: None
User UUID : 7997eefb-6feb-4dbc-a232-c15936633467
User Email : robert cutler@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
19 Nov 2020 13 28:050-0500 Christine Mina EPakStateChanged The ePak progressed to the next workflow state .
User UU D : a3b2e181-3aee-4aea-b101-ec31853d0033
User Email : christine [email protected]
19 Nov 2020 13 28:050-0500 Christine Mina RequestSent Sign request sent to ePak recipient.
User UU D : a3b2e181-3aee-4aea-b101-ec31853d0033
User Email : christine [email protected]
20 Nov 2020 10:11:005-0500 Cecilia Gabarain C4591001 Phase 2_3 Au dit
Cert 19-Nov-2020.pdfDocumentViewed Document viewed by signer.
User UUID : 6809829b-f9ec-4ac9-bc23-e28cfba721dc
User Email : ceciliabeatriz gabarain@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
20 Nov 2020 10:12:040-0500 Cecilia Gabarain C4591001 Phase 2_3 Au dit
Cert 19-Nov-2020.pdfSignerTagFilled The signer filled Time Stamp.
Value: 20 Nov 2020 10:12:039-0500
User UUID : 6809829b-f9ec-4ac9-bc23-e28cfba721dc
User Email : ceciliabeatriz gabarain@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
20 Nov 2020 10:12:040-0500 Cecilia Gabarain C4591001 Phase 2_3 Au dit
Cert 19-Nov-2020.pdfSigned The recipient signed the document with no comments.
Comments: None
Reason: None
User UUID : 6809829b-f9ec-4ac9-bc23-e28cfba721dc
User Email : ceciliabeatriz gabarain@pfizer com
Document UU D : dd1d3c42-4215-4faf-843f-b1d1d2d5c436
20 Nov 2020 10:12:040-0500 Christine Mina Completed The ePak completed the workflow successfully custodian.
User UU D : a3b2e181-3aee-4aea-b101-ec31853d0033
User Email : christine [email protected]
Page 4
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