125742 S1 M5 CRF c4591001 1251 12511250

Document text

Page 1 of 139
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833055
Page 2 of 139
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833056
Page 3 of 139
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511250]
2.Birth Date: /1953
3.Sex: MALE
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:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833057
Page 4 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833058
Page 5 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833059
Page 6 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833060
Page 7 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gout]
Start Date: Jan/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tobacco Dependence 1/2 ppd]
Start Date: UNK/UNK/1968
Ongoing: YES
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833061
Page 8 of 139
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis right knee]
Start Date: UNK/UNK/2000
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[partial knee replacement]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[knee arthroscopy right]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833062
Page 9 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833063
Page 10 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [226.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [32.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833064
Page 11 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [270319]
3.Randomization Group: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833065
Page 12 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BR90V0]
5.bSample ID [BR90WB]
5.cSample ID [BR90WC]
5.dSample ID [BNWBRR]
5.eSample ID [BNWBRS]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833066
Page 13 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BR90T7]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833067
Page 14 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/20/2020 10:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833068
Page 15 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833069
Page 16 of 139
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833070
Page 17 of 139
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Nov/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833071
Page 18 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BR914X]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833072
Page 19 of 139
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/11/2020 09:12
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833073
Page 20 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/9/2020
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833074
Page 21 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[3 samples only poor venous access]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8ZXC]
5.bSample ID [BM8ZXD]
5.cSample ID [BNVKBP]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833075
Page 22 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833076
Page 23 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833077
Page 24 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833078
Page 25 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833079
Page 26 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833080
Page 27 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833081
Page 28 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833082
Page 29 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833083
Page 30 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833084
Page 31 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833085
Page 32 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833086
Page 33 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833087
Page 34 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833088
Page 35 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833089
Page 36 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833090
Page 37 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833091
Page 38 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  increased pain with
activities-right knee Dec/2/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833092
Page 39 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[increased pain with activities-right knee]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833093
Page 40 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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:
[increased activities]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833094
Page 41 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020488165]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833095
Page 42 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryMedication
ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication E
rrors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833096
Page 43 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start 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?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833097
Page 44 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833098
Page 45 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: //
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833099
Page 46 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833100
Page 47 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833101
Page 48 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833102
Page 49 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833103
Page 50 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833104
Page 51 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833105
Page 52 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833106
Page 53 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833107
Page 54 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833108
Page 55 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833109
Page 56 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination
1.Was there a temporary delay
of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833110
Page 57 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833111
Page 58 of 139
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833112
Page 59 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833113
Page 60 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833114
Page 61 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833115
Page 62 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833116
Page 63 of 139
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833117
Page 64 of 139
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833118
Page 65 of 139
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR
otherwise not eligible
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833119
Page 66 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833120
Page 67 of 139
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833121
Page 68 of 139
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833122
Page 69 of 139
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833123
Page 70 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/9/2020
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833124
Page 71 of 139
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833125
Page 72 of 139
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833126
Page 73 of 139
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:35:48 (UTC-06:00)
Central Time (US & Canada)NA
Not Applicable
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833127
Page 74 of 139
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833128
Page 75 of 139
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-21-2020
09:34:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-21-2020
09:34:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833129
Page 76 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020
09:35:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/20/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833130
Page 77 of 139
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020
09:34:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12511250Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020
09:34:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1953Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-23-2020
10:36:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-22-2020
07:49:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833131
Page 78 of 139
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-22-2020
07:49:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALETranscription
Error
Oct-22-2020
00:29:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please
complete this
item. Thank
you.
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020
09:35:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020
09:35:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICA
N AMERICANInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833132
Page 79 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020
09:35:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833133
Page 80 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020
09:36:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020
09:36:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020
09:36:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833134
Page 81 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020
09:36:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Gout
Start Date: Jan/UN
K/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020
09:36:59
(UTC-06:00)
Central 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-21-2020
09:36:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
GoutInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833135
Page 82 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.a Start Date:
Date Location User Value Reason
Oct-21-2020
09:36:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020
09:36:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-21-2020
09:37:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History
Term:Gastroesoph
ageal Reflux
Disease
Start Dat
e:UNK/UNK/
2015
Ongoing
:YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833136
Page 83 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-21-2020
09:37:34
(UTC-06:00)
Central 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-21-2020
09:37:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal Refl
ux DiseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-21-2020
09:37:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-21-2020
09:37:34ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833137
Page 84 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Oct-21-2020
09:38:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Tobacco De
pendence 1/
2 ppd
Start Dat
e:UNK/UNK
/1968
Ongoing: YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833138
Page 85 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Oct-21-2020
09:38:13
(UTC-06:00)
Central 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-21-2020
09:38:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Tobacco Dependence 1
/2 ppdInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-21-2020
09:38:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1968Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-21-2020
09:38:13ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833139
Page 86 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Jan-07-2021
08:51:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:osteoarthri
tis right kn
ee
Start Date
:UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0833140
Page 87 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Jan-07-2021
08:51:06
(UTC-06:00)
Central 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
Jan-07-2021
08:51:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritis right kne
eInitial Entry
1.d Start Date:
Date Location User Value Reason
Jan-07-2021
08:51:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jan-07-2021
08:51:06ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833141
Page 88 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Jan-07-2021
08:51:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:partial knee
replacement
Start Dat
e:UNK/UNK/
2009
Ongoing: NO
End Date:
UNK/U
NK/200
9Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833142
Page 89 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Jan-07-2021
08:51:47
(UTC-06:00)
Central 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
Jan-07-2021
08:51:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
partial knee replaceme
ntInitial Entry
1.e Start Date:
Date Location User Value Reason
Jan-07-2021
08:51:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jan-07-2021
08:51:47ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833143
Page 90 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2009
1.f
Date Location User Value Reason
Jan-07-2021
08:52:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:knee arthro
scopy right
Start Date
:UNK/UNK
/2005
Ongoing: NO
End Date:
UNK/U
NK/200
5Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833144
Page 91 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Jan-07-2021
08:52:38
(UTC-06:00)
Central 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
Jan-07-2021
08:52:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
knee arthroscopy rightInitial Entry
1.f Start Date:
Date Location User Value Reason
Jan-07-2021
08:52:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jan-07-2021
08:52:38ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833145
Page 92 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2005
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833146
Page 93 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020
09:38:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT kn
own to be HIV POSITI
VEInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833147
Page 94 of 139
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
226.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833148
Page 95 of 139
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.4Initial Entry
7.a
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.3Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833149
Page 96 of 139
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833150
Page 97 of 139
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020
09:39:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833151
Page 98 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020
09:39:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020
09:39:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
270319Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833152
Page 99 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
09:40:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
09:40:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
09:41:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
09:40:08
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833153
Page 100 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada) entered. Please
review and
correct as
appropriate.
Oct-21-2020
09:40:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
09:41:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR90V0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
09:41:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR90V0Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833154
Page 101 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
09:41:15
(UTC-06:00)
Central Time (US
& Canada)Sample ID
:BR90W
B
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
09:41:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR90WBInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020
09:41:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR90W
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
09:41:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR90WCInitial Entry
5.d
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833155
Page 102 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-21-2020
09:42:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWBR
RInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020
09:42:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWBRRInitial Entry
5.e
Date Location User Value Reason
Oct-21-2020
09:42:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNWBR
SInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833156
Page 103 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Oct-21-2020
09:42:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNWBRSInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833157
Page 104 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
09:43:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
09:43:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
09:43:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
09:43:03
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833158
Page 105 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada) entered. Please
review and
correct as
appropriate.
Oct-21-2020
09:43:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
09:43:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR90T7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
09:43:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR90T7Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833159
Page 106 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833160
Page 107 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 10:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833161
Page 108 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-21-2020
09:44:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833162
Page 109 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-21-2020
09:45:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENIC
ITY E-DIARY NOT C
OLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833163
Page 110 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020
11:42:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833164
Page 111 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2.a
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:97.9
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833165
Page 112 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
2.a Temperature:
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-11-2020
11:42:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833166
Page 113 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020
11:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020
11:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020
11:43:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-11-2020
11:42:49
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833167
Page 114 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada) are entered.
Please review
and correct as
appropriate.
Nov-11-2020
11:42:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020
11:43:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR914XInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020
11:43:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR914XInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833168
Page 115 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833169
Page 116 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020 09:12Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833170
Page 117 of 139
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-11-2020
11:43:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833171
Page 118 of 139
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021
08:31:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833172
Page 119 of 139
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021
08:31:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021
08:31:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-07-2021
08:33:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-07-2021
08:31:49
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833173
Page 120 of 139
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada) are entered.
Please review
and correct as
appropriate.
Jan-07-2021
08:31:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jan-07-2021
08:35:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3 samples only poor v
enous accessInitial Entry
5.a
Date Location User Value Reason
Jan-07-2021
08:33:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM8ZX
CInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833174
Page 121 of 139
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-07-2021
08:33:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM8ZXCInitial Entry
5.b
Date Location User Value Reason
Jan-07-2021
08:34:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM8ZX
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-07-2021
08:34:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM8ZXDInitial Entry
5.c
Date Location User Value Reason
Jan-07-2021
08:34:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BNVKB
PInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833175
Page 122 of 139
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Jan-07-2021
08:34:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVKBPInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833176
Page 123 of 139
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833177
Page 124 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-07-2021
09:37:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-07-2021
08:53:10
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Query 1: Answered Changed data
per query
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833178
Page 125 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
& Canada)
Jan-07-2021
06:34:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened clinical: please
enter relevant
PMH on
MedHx CRF as
noted in SAE
narrative ie hx
of
osteoarthritis in
R knee and
past knee
surgery. CRF
has been
unlocked for
you. Thanks
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
increased pain with
activities-right kneeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/2/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833179
Page 126 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
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).
Date Location User Value Reason
Dec-11-2020
04:56:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-10-2020
11:56:11
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833180
Page 127 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)
Dec-10-2020
11:56:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
YES
Did this serious eve
nt result in persiste
nt or significant dis
ability/incapacity?
NO
Is this serious event
life threatening?
NOChanged
Information
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833181
Page 128 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Other medically im
portant serious eve
nt
NO
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE
increased pain
with
activities-right
knee: Response
to "Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Is the adverse
event serious?'
is marked as
YES, but
responses to all
of the
seriousness
criteria are NO.
At least one
seriousness
criterion is
expected to be
YES for serious
events. Please
review and
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833182
Page 129 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
update as
appropriate.
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
NO
Did this serious eve
nt result in persiste
nt or significant dis
ability/incapacity?
NO
Is this serious event
life threatening?
NOInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833183
Page 130 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Other medically im
portant serious eve
nt
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.
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:
increased activiti
esInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833184
Page 131 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Dec-17-2020
04:13:10
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833185
Page 132 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US &
Canada)
Dec-11-2020
09:34:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged Information
Dec-11-2020
09:34:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGChanged Information
Dec-11-2020
04:58:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020488165,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
NOT
RECInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833186
Page 133 of 139
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Canada) OVE
RED/
NOT
RESO
LVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-10-2020
11:53:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-11-2020
04:56:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020488165Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833187
Page 134 of 139
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-07-2021
08:31:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-07-2021
08:31:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-07-2021
08:31:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833188
Page 135 of 139
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021
09:36:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833189
Page 136 of 139
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-04-2021
09:36:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT wil
ling to return for Vacci
nation 3 OR otherwise
not eligibleInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833190
Page 137 of 139
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-07-2021
08:31:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-21-2020
09:39:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-21-2020
09:36:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-07-2021
08:31:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/9/2020Initial Entry
Oct-21-2020
09:39:48
(UTC-06:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833191
Page 138 of 139
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time (US
& Canada)
Oct-21-2020
09:36:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833192
Page 139 of 139
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Mar-10-2021
13:07:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d09\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0833193