125742 S1 M5 CRF c4591001 1044 10441152

Document text

Page 1 of 230
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909505
Page 2 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/28/2020
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909506
Page 3 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10441152]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)  -  
 
(b) (4)
FDA-CBER-2021-5683-0909507
Page 4 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909508
Page 5 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
  
(b) (4)
FDA-CBER-2021-5683-0909509
Page 6 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909510
Page 7 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hiv]
Start Date: UNK/UNK/2001
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major Depressive Disorder]
Start Date: May/26/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized Anxiety Disorder]
Start Date: Oct/7/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D Deficiency]
Start Date: Aug/24/2018
Ongoing: YES
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909511
Page 8 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: Feb/UNK/2020
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Paroxetine drug intolerance]
Start Date: UNK/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sertraline drug intolerance]
Start Date: UNK/UNK/2016
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Total Hysterectomy]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909512
Page 9 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left breast cancer]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumpectomy]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Breast Cancer]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Breast Cancer]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909513
Page 10 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chemotherapy Treatment]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Breast Cancer]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BREAST RADIATION THERAPY]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chemotherapy Treatment]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909514
Page 11 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is known to be HIV POSITIVE
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909515
Page 12 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [VCUHS Laboratory (VCU Medical Center), Address UNK.]
3.Collection Date: Jul/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [2124]
Test: HIV RNA (Ultrasensitive)
Result: [0.0 copies/ml]
LNMT Low
[log]
High
[log]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909516
Page 13 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [VCUHS Laboratory (VCU Medical Center), Address UNK.]
3.Collection Date: Jul/23/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [4722]
Test: CD4_PX4722
Result: [.129]
LNMT Low
[.377]
High
[1.602]
Unit
10^3/mm3
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909517
Page 14 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
2.Weight: [70.5]
3.Unit: kg
4.Height: [157.5]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
(b) (4)
FDA-CBER-2021-5683-0909518
Page 15 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
  
(b) (4)
FDA-CBER-2021-5683-0909519
Page 16 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/28/2020
2.Randomization Number: [100149]
3.Randomization Group: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909520
Page 17 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLB64X]
5.bSample ID [BLB64L]
5.cSample ID [BN66W4]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   1   1   
(b) (4)
FDA-CBER-2021-5683-0909521
Page 18 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN66WB]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909522
Page 19 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
.Formulation: INJECTION
.Dose Date Time: Sep/28/2020 15:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)       
 
(b) (4)
FDA-CBER-2021-5683-0909523
Page 20 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909524
Page 21 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909525
Page 22 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909526
Page 23 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909527
Page 24 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909528
Page 25 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
  
(b) (4)
FDA-CBER-2021-5683-0909529
Page 26 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW09R]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909530
Page 27 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
.Formulation: INJECTION
.Dose Date Time: Oct/19/2020 12:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)       
 
(b) (4)
FDA-CBER-2021-5683-0909531
Page 28 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909532
Page 29 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909533
Page 30 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909534
Page 31 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
HIV RNA (Ultrasensitive)
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
      
(b) (4)
FDA-CBER-2021-5683-0909535
Page 32 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
CD4_PX4722
Result: Not Done
[ ]Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
      
(b) (4)
FDA-CBER-2021-5683-0909536
Page 33 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVKZ5]
5.bSample ID [BR6HTC]
5.cSample ID [BRVKYR]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   1   1   
(b) (4)
FDA-CBER-2021-5683-0909537
Page 34 of 230
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909538
Page 35 of 230
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909539
Page 36 of 230
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909540
Page 37 of 230
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
1   
(b) (4)
FDA-CBER-2021-5683-0909541
Page 38 of 230
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909542
Page 39 of 230
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
1   
(b) (4)
FDA-CBER-2021-5683-0909543
Page 40 of 230
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909544
Page 41 of 230
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909545
Page 42 of 230
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909546
Page 43 of 230
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
1   
(b) (4)
FDA-CBER-2021-5683-0909547
Page 44 of 230
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909548
Page 45 of 230
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909549
Page 46 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4)
FDA-CBER-2021-5683-0909550
Page 47 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
.Symptoms:
Was symptom present?
Sy ptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 r 
(b) (4)
FDA-CBER-2021-5683-0909551
Page 48 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909552
Page 49 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909553
Page 50 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
(b) (4)
FDA-CBER-2021-5683-0909554
Page 51 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909555
Page 52 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4)
FDA-CBER-2021-5683-0909556
Page 53 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909557
Page 54 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4)
FDA-CBER-2021-5683-0909558
Page 55 of 230
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909559
Page 56 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909560
Page 57 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909561
Page 58 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden i
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  oral Ulcer  Oct/24/2020 UNK
:UNK NO
End Date Time:
Oct/26/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  Stomatitis  Oct/24/2020 UNK
:UNK NO
End Date Time:
Oct/26/2020 UNK:UN
K
 Repeating
Pages
 3ADVERSE E
VENT 3  breast cancer initial di
agnosis Dec/28/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) I     
  I  -
(b) (4)
FDA-CBER-2021-5683-0909562
Page 59 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[oral Ulcer]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
(b) (4)
FDA-CBER-2021-5683-0909563
Page 60 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4)
FDA-CBER-2021-5683-0909564
Page 61 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Stomatitis]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
(b) (4)
FDA-CBER-2021-5683-0909565
Page 62 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4)
FDA-CBER-2021-5683-0909566
Page 63 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[breast cancer initial diagnosis]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
Did this serious event result in death?
Did this serious event require or prolong hospitalization?
Did this serious event result in persistent or significant disability/incapacity?
Is this serious event life threatening?
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[new onset breast cancer]
0.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
 
(b) (4)
FDA-CBER-2021-5683-0909567
Page 64 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021236851]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909568
Page 65 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
C tego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
  .          Repeating
Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)     -
(b) (4)
FDA-CBER-2021-5683-0909569
Page 66 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1Category:
2.Medication Error (Type of
Medication Error):[ ]
3Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
0.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
   
(b) (4)
FDA-CBER-2021-5683-0909570
Page 67 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationtart D
ateForm Instanc
e
 1          Repeating
Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   I 
    -
(b) (4)
FDA-CBER-2021-5683-0909571
Page 68 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4)
FDA-CBER-2021-5683-0909572
Page 69 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909573
Page 70 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
.What is the medication identifier? [ ]
.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
.Dose: [ ]
.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
     
(b) (4)
FDA-CBER-2021-5683-0909574
Page 71 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
C egor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edT atmen
tStart D
eForm Instance
 1          Repeating Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
     
(b) (4)
FDA-CBER-2021-5683-0909575
Page 72 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
   
(b) (4)
FDA-CBER-2021-5683-0909576
Page 73 of 230
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909577
Page 74 of 230
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909578
Page 75 of 230
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909579
Page 76 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909580
Page 77 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909581
Page 78 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
  
(b) (4)
FDA-CBER-2021-5683-0909582
Page 79 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
.Formulation:
.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)       
 
(b) (4)
FDA-CBER-2021-5683-0909583
Page 80 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909584
Page 81 of 230
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909585
Page 82 of 230
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909586
Page 83 of 230
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909587
Page 84 of 230
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909588
Page 85 of 230
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
1   
(b) (4)
FDA-CBER-2021-5683-0909589
Page 86 of 230
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909590
Page 87 of 230
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909591
Page 88 of 230
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909592
Page 89 of 230
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909593
Page 90 of 230
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909594
Page 91 of 230
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
 
 
(b) (4)
FDA-CBER-2021-5683-0909595
Page 92 of 230
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/16/2020
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909596
Page 93 of 230
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909597
Page 94 of 230
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Aaron Hartman  Approved Mar-10-2021 14:05:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
(b) (4)
FDA-CBER-2021-5683-0909598
Page 95 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-28-2020 19:57:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909599
Page 96 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-20-2020 03:44:02 (UTC-05:00) Eastern
Time (US & Canada)subject did not have Cd4 and HIv RNA
samples collected during this period
FormNov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909600
Page 97 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909601
Page 98 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909602
Page 99 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909603
Page 100 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909604
Page 101 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909605
Page 102 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909606
Page 103 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909607
Page 104 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-20-2020 03:43:38 (UTC-05:00) Eastern
Time (US & Canada)subject did not have Cd4 and HIv RNA
samples collected during this period
FormNov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909608
Page 105 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909609
Page 106 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909610
Page 107 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909611
Page 108 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909612
Page 109 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909613
Page 110 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909614
Page 111 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909615
Page 112 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Aaron Hartman  Approved Mar-10-2021 14:05:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 A Mar-04-2021 05:27:43 (UTC-05:00) Eastern
Time (US & Canada)dit - All
gnatures
nvalidate
Affidavit:
N/A
Aaron Hartman  Approved Nov-24-2020 20:28:47 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 A Nov-19-2020 06:42:06 (UTC-05:00) Eastern
Time (US & Canada)dit - All
gnatures
nvalidate
Affidavit:
N/A
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
  
    
  
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909616
Page 113 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aaron Hartman  Approved Nov-16-2020 17:49:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N A Nov-16-2020 17:47:43 (UTC-05:00) Eastern
Time (US & Canada)Ed   All
sig atures
inv lidated
Affidavit:
N/A
Aaron Hartman  Approved Nov-16-2020 16:19:50 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N A Nov-13-2020 23:44:21 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
ignatures
i validated
Affidavit:
N/A
Aaron Hartman  Approved Nov-10-2020 17:31:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
    
 C  
    
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909617
Page 114 of 230
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, AaronHartman, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909618
Page 115 of 230
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-28-2020 19:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020nitial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-28-2020 19:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSnitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
   
  
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909619
Page 116 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-28-2020 19:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/28/2020Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909620
Page 117 of 230
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
ep-28-2020 19:56:47
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( uto alc)Data Entry:
10441152It m copied from
pr vious form
2. Birth Date:
Date Location User Value Reason
ep-28-2020 19:56:44
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( utocalData Entry:
/1968Enrollment Entry
3. Sex:
Date Location User Value Reason
ep-28-2020 19:57:20
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEnitial Entry
4. Ethnicity:
Date Location User Value Reason
ep-28-2020 19:57:20
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINnitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
ep-28-2020 19:57:20
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMER
ICANnitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6) 
         
 
       - 
 
       
 
       
 
       
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909621
Page 118 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020 19:31:45
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
uery
Nov-16-2020 17:48:09
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered D4 Form updated
Nov-10-2020 06:17:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM 1: Kindly
review and update
CD4 form or else
clarify. Thank you.
Nov-04-2020 00:49:05
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate to be followed up
Nov-03-2020 16:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered awaiting reports
from PCP Will
update when
obtained
Oct-29-2020 03:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Kindly
review and update
CD4 form or else
clarify. Thank you.
Oct-17-2020 02:21:28
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate o be followed up
Oct-16-2020 09:16:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subjects PCP has
been contacted and
records requested.
Will updated EDC
when obtained
Oct-15-2020 23:44:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
missing HIV RNA
and CD4 forms or
else clarify. Thank
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  I   I I    
  I    
  
  I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0909622
Page 119 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
you.
Sep-28-2020 19:57:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
S p/28/2020Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    1I  
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909623
Page 120 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-28-2020 19:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 19:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 19:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909624
Page 121 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-28-2020 19:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hiv
Start Date: UNK/UNK/2
001
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-28-2020 19:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-05-2020 13:09:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-04-2020 22:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirmed
Oct-03-2020 14:45:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened GPDCLIN: please
also confirm that
patient is not being
treated for HIV
related infection.
Oct-01-2020 15:26:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirmed on
HAART and not
being treated for
malignancy
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
L ~  
 
 
  
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0909625
Page 122 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020 11:50:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN: Please
confirm the
participant IS or IS
NOT receiving
HAART currently
and please confirm
the participant IS or
IS NOT being
treated for
HIV-associated
infection or
malignancy.
Sep-28-2020 19:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hivInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-28-2020 19:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Init  Entry
1.a Ongoing:
Date Location User Value Reason
Sep-28-2020 19:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitia  Entry
1.b
Date Location User Value Reason
Oct-23-2020 13:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Major Depressiv
e Disorder
Start Date: May/26/2016
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
   
   
 
   
    
 
  
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909626
Page 123 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Major Depressive DisorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-23-2020 13:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/26/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-23-2020 13:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location U er Value Reason
Oct-23-2020 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto l
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Generalized Anxi
ety Disorder
Start Date: Oct/7/2016
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 -
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909627
Page 124 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Generalized Anxiety DisorderInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-23-2020 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-23-2020 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location U er Value Reason
Oct-23-2020 13:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto l
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Vitamin D Defi
ciency
Start Date: Aug/24/2018
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
  
 -
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909628
Page 125 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin D DeficiencyInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-23-2020 13:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-23-2020 13:28:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location U er Value Reason
Oct-23-2020 13:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto l
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Asthma
Start Date: Feb/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 -
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909629
Page 126 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-23-2020 13:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-23-2020 13:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location U er Value Reason
Oct-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto l
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Paroxetine drug i
ntolerance
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
  
 -
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909630
Page 127 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Paroxetine drug intoleranceInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-23-2020 13:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location U er Value Reason
Oct-23-2020 13:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto l
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Sertraline drug in
tolerance
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 -
 
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909631
Page 128 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sertraline drug intoleranceInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-23-2020 13:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-23-2020 13:30:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-27-2020 05:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Total Hysterec
tomy
Start Date: UNK/UNK/2
008New Information
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
   
      
     
     
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0909632
Page 129 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK
/2008
Oct-23-2020 13:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Total Hystere
ctomy
Start Date: UNK/UNK/2
008
Ongoing: YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909633
Page 130 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Total HysterectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-23-2020 13:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-28-2020 19:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-27-2020 05:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-27-2020 05:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008New Information
Oct-27-2020 04:52:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Hysterectomy: as
this is a procedure,
please provide a
stop date.
Oct-26-2020 20:56:03 ACV0PFEINFP6000  Query 1: Candidate ClinQuery:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
   
      
     
     
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909634
Page 131 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)Hysterectomy: as
this is a procedure,
please provide a
stop date.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0909635
Page 132 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.h Ongoing:
Date Location User Value Reason
Oct-23-2020 13:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-23-2020 13:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Left breast canc
er
Start Date: UNK/UNK/200
9
Ongoing: NO
End Date:
UNK/UNK/
2009Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
   
 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909636
Page 133 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Left breast cancerInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-23-2020 13:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-23-2020 13:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.j
Date Location User Value Reason
Oct-24-2020 14:20:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Lumpectomy
Start Date: UNK/UNK/2
009Transcription Error
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
     
    
     
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909637
Page 134 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UN
K/2009
Oct-23-2020 13:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical
History T
erm:Left Breast Cancer
Treatment -- Lump
ectomy
Start Dat
e:UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/200
9Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909638
Page 135 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020 14:20:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LumpectomyTranscription Error
Oct-23-2020 13:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Left Breast Cancer Treatment -
- LumpectomyInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-23-2020 13:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-23-2020 13:32:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.k
Date Location User Value Reason
Oct-24-2020 14:11:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Left Breast C
ancerTranscription Error
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909639
Page 136 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
009
Ongoing: NO
End Date:
UNK/UN
K/2009
Oct-24-2020 04:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:Left Breast Cancer
Treatment Chemo
Start Date
:UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/20
09New Information
Oct-23-2020 13:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:Left Breast Cancer
Treatment -- Chem
o
Start Date
:UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/200
9Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909640
Page 137 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020
14:55:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Cl
osedDiscrepancy has
been closed.
Oct-24-2020
14:11:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredTranscription Error
Oct-24-2020
14:11:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: De
letedClose Auto Query
Oct-24-2020
14:11:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Left Breast
CancerTranscription Error
Oct-24-2020
05:40:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: O
penedSpacing: Verbatim
Term contains
leading, trailing or
more than one
consecutive space.
Oct-24-2020
05:22:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Cl
osedDiscrepancy has
been closed.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)      
 
 
 
         
             
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909641
Page 138 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-24-2020
04:46:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: A
nsweredNew Information
Oct-24-2020
04:46:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Left Breast
Cancer Trea
tment Chem
oNew Information
Oct-23-2020
18:27:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: O
penedSpacing: Verbatim
Term contains
leading, trailing or
more than one
consecutive space.
Oct-23-2020
13:33:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ca
ndidateExtra blank spaces
are present
between words in
the
Disease/Syndrome
Term which may
impact coding.
Please review and
remove any extra
spaces.
Oct-23-2020
13:33:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Left Breast
Cancer Trea
tment -- Ch
emoInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-23-2020 13:33:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initia  Entry
1.k Ongoing:
Date Location User Value Reason
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
   
    
 
    
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909642
FDA-CBER-2021-5683-0909643
Page 140 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020
14:55:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy has
been closed.
Oct-24-2020
14:17:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Oct-24-2020
14:17:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Left Breast C
ancerTranscription
Error
Oct-24-2020
05:54:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedMultiple
concepts in the
term LEFT
BREAST
CANCER
TREATMENT
-- RADIATION.
Split the term
into LEFT
BREAST
CANCER and
BREAST
RADIATION
THERAPY and
report as 2
separate entries.
Thank you.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
  
 
 
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909644
Page 141 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-23-2020
13:35:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Left Breast C
ancer Treatme
nt -- Radiatio
nInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-23-2020 13:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initia  Entry
1.l Ongoing:
Date Location User Value Reason
Oct-23-2020 13:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.m
Date Location User Value Reason
Oct-24-2020 14:20:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:Chemotherapy
Treatment
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013Transcription Error
Oct-24-2020 14:19:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:Left Breast C
ancerTranscription Error
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
    
 
  
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909645
Page 142 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
013
Ongoing: NO
End Date:
UNK/UN
K/2013
Oct-23-2020 13:35:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:13
Medical H
istory Ter
m:Left Breast Cancer
Treatment -- Chem
o
Start Date
:UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/201
3Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909646
Page 143 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:35:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020
14:55:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: C
los dDiscrepancy has
been closed.
Oct-24-2020
14:20:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Chemother
apy Treatm
entTranscription Error
Oct-24-2020
14:19:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription Error
Oct-24-2020
14:19:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Left Breast
CancerTranscription Error
Oct-24-2020
05:40:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedMultiple concepts in
the term LEFT
BREAST CANCER
TREATMENT --
CHEMO. Split the
term into LEFT
BREAST CANCER
and
CHEMOTHERAPY
and report as 2
separate entries.
Thank you.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  Ll    
  
 
 
 
   
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909647
Page 144 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-23-2020
13:35:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Left Breast
Cancer Tre
atment -- C
hemoInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909648
Page 145 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.m Start Date:
Date Location User Value Reason
Oct-23-2020 13:35:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-23-2020 13:35:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.n
Date Location User Value Reason
Oct-24-2020 14:21:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Left Breast C
ancer
Start Date: UNK/UNK/2
017
Ongoing: NO
End Date:
UNK/UN
K/2017Transcription Error
Oct-24-2020 04:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:Left Breast Cancer
Treatment Chemo
Start Date
:UNK/UNK/2017Transcription Error
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
   
   
 
  
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909649
Page 146 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/20
17
Oct-23-2020 13:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:Left Breast Cancer
Treatment -- Chem
o
Start Date
:UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/201
7Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909650
Page 147 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020
14:56:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: C
losedDiscrepancy has
been closed.
Oct-24-2020
14:21:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredTranscription Error
Oct-24-2020
14:21:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Left Breast
CancerTranscription Error
Oct-24-2020
07:04:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: O
penedMultiple concepts in
the term LEFT
BREAST CANCER
TREATMENT
CHEMO. Split the
term into LEFT
BREAST CANCER
and
CHEMOTHERAPY
and report as 2
separate entries.
Thank you.
Oct-24-2020
05:22:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: C
losedDiscrepancy has
been closed.
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT).   
 
 
 
  
    
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909651
Page 148 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-24-2020
04:46:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: A
nsweredTranscription Error
Oct-24-2020
04:46:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: D
eletedClose Auto Query
Oct-24-2020
04:46:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Left Breast
Cancer Tre
atment Ch
emoTranscription Error
Oct-23-2020
18:28:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: O
penedSpacing: Verbatim
Term contains
leading, trailing or
more than one
consecutive space.
Oct-23-2020
13:36:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: C
andidateExtra blank spaces
are present between
words in the
Disease/Syndrome
Term which may
impact coding.
Please review and
remove any extra
spaces.
Oct-23-2020
13:36:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
Left Breast
Cancer Tre
atment -- C
hemoInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-23-2020 13:36:25
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)-
 
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909652
Page 149 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.n Ongoing:
Date Location User Value Reason
Oct-23-2020 13:36:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.o
Date Location User Value Reason
Oct-24-2020 14:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical His
tory Term:BREAST RADIATI
ON THERAPY
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
  
 
  
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909653
Page 150 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Oct-24-2020 14:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020 14:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BREAST RADIATION THERA
PYInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-24-2020 14:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-24-2020 14:18:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.p
Date Location User Value Reason
Oct-24-2020 14:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:16
Medical Histor
y Term:Chemotherapy Tr
eatment
Start Date: UNK/UNK/2017Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
   u    
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909654
Page 151 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/20
17
1.p Line/MH Number:
Date Location User Value Reason
Oct-24-2020 14:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-24-2020 14:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chemotherapy TreatmentInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-24-2020 14:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-24-2020 14:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909655
Page 152 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-14-2020 07:16:14
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  A med Has n Query 2: Closed Response satisfies
uery
Nov-13-2020 14:02:48
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Original value is
correct
Nov-10-2020 03:07:14
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed As per site
onfirmation -
updated PD tracker
Nov-09-2020 05:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Data management
requested diary data
collection marked
as positive for
collection although
subject will not be
submitting data
Nov-09-2020 04:46:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened PDQ : Response to
What is the subject
HIV status? is "The
subject is known to
be HIV
POSITIVE",
however eDairy
data is missing for
this subject. Please
review and update if
the diary data is
available else
provide a
clarification.
Nov-07-2020 12:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 2: Reissued:Opened Please keep the
query with you until
the data is received,
in order to prevent
another query being
raised and to keep
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) I   I I   I   I 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909656
Page 153 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
oversight of the
query. Thanks for
your understanding.
Nov-07-2020 12:20:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered it has been
requested thru PCP
and subject Will
update when
received
Nov-07-2020 11:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  A med Has n Query 2: Opened ClinQuery: Please
can you update the
CD4 Count result
and range? Thanks
Oct-07-2020 20:55:53
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
uery
Oct-06-2020 04:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered HIV Viral Load &
CD4 Counts within
the last 6 months
requested from
Provider
Oct-01-2020 20:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
update CRF with
viral load and CD4
count
ep-28-2020 19:58:05
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is known to be HI
V POSITIVEnitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   I   I 
       
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909657
Page 154 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VCUHS Laboratory (VCU Medi
cal Center), Address UNK.Initial Entry
3. Collection Date:
Date Location User Value Reason
Nov-17-2020 10:30:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 2: Closed Response satisfies
query
Nov-17-2020 08:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered CD4 CRF was
updated yesterday
16/Nov/2020
17:47:43
(UTC-05:00)
Nov-17-2020 00:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clin: Please can you
confirm if subject
DID or DID NOT
have a CD4 blood
test within the
timeframe of 6
months prior to
randomisation
through V2? If so,
update the CD4
CRF as appropriate.
Else clarify. Thanks
Nov-16-2020 09:29:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 2: Candidate Clin: Please can you
confirm if subject
DID or DID NOT
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909658
Page 155 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
have a CD4 blood
test within the
timeframe of 6
months prior to
randomisation
through V2? If so,
update the CD4
CRF as appropriate.
Else clarify. Thanks
Nov-14-2020 07:16:03
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassa Query 1: Closed Response satisfies
uery
Nov-13-2020 14:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Lab Report received
-- Normal Range is
listed as "log" per
report. Panel
"HIV-1 RNA Qnt
(log). Component
"HIV-1 RNA Qnt
(log)".
Nov-07-2020 12:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Reissued:Opened Please keep the
query with you until
the data is received,
in order to prevent
another query being
raised and to keep
oversight of the
query. Thanks for
your understanding.
Nov-07-2020 12:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered it has been
requested thru PCP
and subject Will
update when
received
Nov-07-2020 11:55:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassa Query 1: Opened ClinQuery: Please
can you update the
Viral RNA result
and range? Thanks
Oct-23-2020 11:30:55
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/23/2020nitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)I   I 
   I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909659
Page 156 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Specimen Type:
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Nov-13-2020 23:44:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defin
ed Identifier:2124
Test:: HIV RNA (Ul
trasensitive)
Result:: 0.0 copies/ml
Lab Normal R
ange:Low
log
High
logNew Information
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:2124
Test:: HIV RNA (Ul
trasensitive)
Result:: 0.0
Lab Normal R
ange:Low
log
High
logInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  uto calc
(autocalc)Data Entry:
2124Initial Entry
5.a Test:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
  
 
 
  
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909660
Page 157 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HIV RNA (Ultrasensitive)Init  Entry
5.a Result:
Date Location User Value Reason
Nov-14-2020 09:06:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-14-2020 08:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-13-2020 23:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per
uery
Nov-13-2020 23:44:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Nov-13-2020 23:44:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  au o query
(a toquery)Query 2: Answered New Information
Nov-13-2020 23:44:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  D ta Entry:
0.  copies/mlNew Information
Nov-13-2020 21:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Er ca Weaver Query 2: Opened ls select UNIT.
Oct-31-2020 12:28:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
uery
Oct-30-2020 14:47:25
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered Transcribed per
Laboratory Report
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
    
 
  
 
 
 
 
    
    
    
    
    
   
 
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909661
Page 158 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Oct-29-2020 10:45:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  S dip
N mdeorao
S yawanshQuery 1: Reissued:Opened Kindly update unit
here or else clarify.
Thank you
Oct-28-2020 16:27:41
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered r quested
Oct-26-2020 07:49:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Result is
present, but lab
normal range (Unit)
is missing. Please
correct or confirm
Oct-23-2020 11:32:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per Laboratory
Report: HIV-1
RNA Qnt = 0.0.
Normal Range =
log.
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high or
Unit) is missing.
Please correct or
confirm.
Oct-23-2020 11:30:55
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  D ta Entry:
0Initia  Entry
5.a LNMT
Date Location User Value Reason
Oct-23-2020 11:30:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
log
High
logInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
  I    
I    
 
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909662
Page 159 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( utocalcData Entry:
HEMATOLOGYnitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VCUHS Laboratory (VCU Medi
cal Center), Address UNK.nitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/23/2020nitial Entry
4. Specimen Type:
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
BLOODnitial Entry
5.a
Date Location User Value Reason
Mar-08-2021 14:33:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: .129New Information
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
I    
   
I   
   
I   
    
I  1   
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909663
Page 160 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Normal Rang
e:Low
.377
High
1.602
Unit
10^3/m
m3
Mar-05-2021 14:44:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: .129
Lab Normal Rang
e:Low
377
High
1602
Unit
10^3/m
m3Transcription Error
Nov-16-2020 17:47:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 129
Lab Normal Rang
e:Low
377
High
1602
Unit
10^3/m
m3Initial Entry
5.a Sponsor ID:
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909664
Page 161 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( utocalcData Entry:
4722In tial Entry
5.a Test:
Date Location User Value Reason
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CD4_PX4722I itial Entry
5.a Result:
Date Location User Value Reason
Mar-12-2021 10:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Candidate CLINQUERY: It is
reported that subject
was eligible per
protocol. However,
CD4 count is less
than .200
10^3/mm3, which
makes the subject
ineligible per
Section 10.8 of the
protocol. Please
verify CD4 and if
correct, update CRF
to indicate
ineligiblity.
Mar-09-2021 11:13:23
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed R sponse satisfies
query
Mar-08-2021 14:33:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered C anged data per
query
Mar-08-2021 09:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
Query response
confirms lab normal
ranges should be
updated, but no
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)     I    
 
   I  1  
 
 
I    
I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909665
Page 162 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
changes were made
to the CRF. Please
verify that the LLN
for CD4 should be
updated to .377 and
the ULN should be
updated to 1.602
accordingly.
Mar-08-2021 06:44:15
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirmed
Mar-05-2021 17:32:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY:
Thank you for
updating Result to
.129. However, Lab
Normal Range
Values have not
been updated.
Please verify they
should be updated
to .377 (LLN) and
1.602 (ULN) to
represent the units
of 10^3/mm3.
Mar-05-2021 14:44:30
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a o query
( oquery)Query 1: Answered Transcription Error
Mar-05-2021 14:44:30
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
.129Transcription Error
Mar-05-2021 12:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: CD4
value is reported as
129. Please note
that CD4 should be
reported in
10^3/mm^3. Please
verify that the value
should be divided
by 1000 to capture
in the correct units
(.129). Please
ensure normal
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)I    
I    
I    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909666
Page 163 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ranges are corrected
as applicable too.
Nov-16-2020 17:47:43
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
129Initial Entry
5.a LNMT
Date Location User Value Reason
Mar-08-2021 14:33:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
.377
High
1.602
Unit
10^3/mm3New Information
Nov-16-2020 17:47:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
377
High
1602
Unit
10^3/mm3Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)   
I    
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909667
Page 164 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020nitial Entry
2. Weight:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
70.5nitial Entry
3. Unit:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgnitial Entry
4. Height:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
157.5nitial Entry
5. Unit:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmnitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
28.4Initial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
 
    
    
 
    
    
 
    
    
 
    
    
 
    
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909668
Page 165 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.3
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initia  Entry
7.a Temperature:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Init  Entry
7.a Unit:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitia  Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 20:04:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)     
 
  
 
      
 
  
    
 
  
    
 
  
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909669
Page 166 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
URINALYSISnitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
PREGNANCYnitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
STUDY SITEnitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
URINEnitial Entry
6.a
Date Location User Value Reason
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
 
    
    
 
    
    
 
    
    
 
    
    
 
     
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909670
Page 167 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-28-2020 20:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909671
Page 168 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-28-2020 20:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020nitial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-28-2020 20:03:43
(UTC-05:00) Eastern
T me (US & Canada)ACV0PFEINFP6000  Data Entry:
100149nitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
 
    
11    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909672
Page 169 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 20:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 20:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 20:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 20:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 20:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 20:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB64XInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909673
Page 170 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 20:02:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB64XInitia  Entry
5.b
Date Location User Value Reason
Sep-28-2020 20:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB64LInitia  Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 20:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB64LInitia  Entry
5.c
Date Location User Value Reason
Sep-28-2020 20:03:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN66W4Init  Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 20:03:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN66W4Initia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
    
  
    
    
  
    
    
  
    
   
  
    
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909674
Page 171 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 20:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 20:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 20:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 20:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 20:02:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 20:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN66WBInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909675
Page 172 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 20:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN66WBIn  try
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909676
Page 173 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020 15:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
        
 
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909677
Page 174 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 20:01:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
  
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909678
Page 175 of 230
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User ValueReason
Nov-03-2020
16:50:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Del
etedTranscription Error
Nov-03-2020
16:50:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YES -
REA
CTO
GENI
CITY
E-DI
ARY
COLL
ECTE
D FO
R THI
S SU
BJEC
TTranscription Error
Oct-09-2020
10:23:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
dateEmail sent to CRA
and Study team on
09Oct2020.
Oct-08-2020
05:12:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dReactogenicity
subset closed.
Oct-08-2020
03:59:12ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY uery
: OpDMW4908930;What
is the subject HIV
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
I   
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909679
Page 176 of 230
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time
(US &
Canada)enedstatus? is "The
subject is known to
be HIV POSITIVE",
but Reactogenicity
diary collection is
"NO -
REACTOGENICITY
E-DIARY NOT
COLLECTED FOR
THIS SUBJECT".
Please review and
update as
appropriate.
Sep-28-2020
20:01:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NO -
REA
CTO
GENI
CITY
E-DI
ARY
NOT
COLL
ECTE
D FO
R THI
S SU
BJEC
TInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0909680
Page 177 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 01:48:34
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site
confirmation Not
COVID RELATED
Oct-29-2020 12:03:05
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered P  deemed not
c vid related
Oct-29-2020 11:15:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
26OCT2020. But
corresponding
COVID Illness visit
not reported. Please
clarify.
Oc -2020 13:45
(U 05:00) Easte
Tim  US & CanadACV0PFEINFP6000  Data Entry:
Oct/19/2020In tial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)I ----- - -- -  
I    
   
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909681
Page 178 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.a
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERnitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.b
Date Location User Value Reason
ov-03-2020 16:53:21
UTC-05:00) Eastern
ime (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
 
  
   
  
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909682
Page 179 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitia  Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOIn tial Entry
2.c
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909683
Page 180 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitia  Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.d
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitia  Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.e
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
 
 
  
  1  
 
  
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909684
Page 181 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitia  Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInit al Entry
2.f
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
  
  1  
 
  
  1  
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909685
Page 182 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitia  Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.g
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE PAINInit al Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
  
 
  
  1  
 
  
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909686
Page 183 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-03-2020 16:53:21
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
P INInitia  Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-03-2020 16:53:21
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( utocalcData Entry:
DELTOID MUSCLEIn tial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-03-2020 16:53:21
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
 
  I  1  
 
  I  1  
 
    I    
 
  I  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909687
Page 184 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitia  Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
5.b
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
  
  1  
 
  
  1  
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909688
Page 185 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitia  Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
5.c
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitia  Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-03-2020 16:53:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
 
 
  
  1  
 
  
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909689
Page 186 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020nitial Entry
2.a
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.2
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1nitial Entry
2.a Temperature:
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2nitial Entry
2.a Unit:
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Fnitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
 
  
    
  
    
  
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909690
Page 187 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Oct-19-2020 13:45:51
(UTC-05:00) Eastern
ime (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
1    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909691
Page 188 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
URINALYSISnitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
PREGNANCYnitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
STUDY SITEnitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocal )Data Entry:
URINEnitial Entry
6.a
Date Location User Value Reason
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
 
    
    
 
    
    
 
    
    
 
    
    
 
     
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909692
Page 189 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Oct-19-2020 13:46:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909693
Page 190 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 13:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 13:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 13:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 13:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-19-2020 13:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 13:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW09RInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909694
Page 191 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 13:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW09RIn  try
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909695
Page 192 of 230
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020 12:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
        
 
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909696
Page 193 of 230
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-19-2020 13:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909697
Page 194 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 01:08:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-20-2020 03:38:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject did not have
Cd4 and HIv RNA
samples collected
during this period
Nov-19-2020 23:51:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened As per your
response ' subject
did not have Cd4
and HIv RNA
samples collected
during this period',
but FORM level
comment is
missing. Please
enter a Form Level
Comment of Not
Done as per section
4.10.
Nov-19-2020 06:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject did not have
Cd4 and HIv RNA
samples collected
during this period
Nov-18-2020 03:26:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete
‘Hematology and
Chemistry' at this
visit. Thank you.
Nov-16-2020 12:35:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/16/2020In tial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  I 
  
  
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909698
Page 195 of 230
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.a
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERnitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOnitial Entry
2.b
Date Location User Value Reason
ov-16-2020 12:36:13
UTC-05:00) Eastern
ime (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
 
  
   
  
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909699
Page 196 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitia  Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOIn tial Entry
2.c
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909700
Page 197 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitia  Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.d
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitia  Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.e
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
 
 
  
  1  
 
  
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909701
Page 198 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitia  Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInit al Entry
2.f
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
  
  1  
 
  
  1  
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909702
Page 199 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitia  Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
2.g
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE PAINInit al Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  1  
 
  
  1  
 
  
 
  
  1  
 
  
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909703
Page 200 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Nov-16-2020 12:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-16-2020 12:36:13
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
P INInitia  Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-16-2020 12:36:13
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitia  Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-16-2020 12:36:13
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( utocalcData Entry:
DELTOID MUSCLEIn tial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-16-2020 12:36:13
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitia  Entry
090177e196ae3e60\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
 
  I  1  
 
  I  1  
 
    I    
 
  I  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909704
Page 201 of 230
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-20
…[truncated]