Document text
Page 1 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878223
Page 2 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878224
Page 3 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12313783]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878225
Page 4 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878226
Page 5 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878227
Page 6 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878228
Page 7 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878229
Page 8 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878230
Page 9 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878231
Page 10 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kidney stones]
Start Date: Jan/1/1961
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Irritable colon]
Start Date: Jan/1/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L4-L5 disc herniation]
Start Date: Dec/UNK/2013
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Surgical placement of interspinous spacer at L4-L5]
Start Date: Dec/6/2013
Ongoing: NO
End Date:
Dec/6/2013
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878232
Page 11 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial hypertension]
Start Date: UNK/UNK/2012
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jun/15/2020
Ongoing: YES
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878233
Page 12 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [88.0]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [29.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878234
Page 13 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [239190]
3.Randomization Group: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878235
Page 14 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[As stated in the medical history, the samples could not be processed, which is
why they did not arrive at the central laboratory]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP24RC]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878236
Page 15 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP24RC]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878237
Page 16 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: Aug/24/2020 20:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878238
Page 17 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878239
Page 18 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878240
Page 19 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878241
Page 20 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP2FVP]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878242
Page 21 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: Sep/14/2020 20:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878243
Page 22 of 168
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878244
Page 23 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BK6KWC]
5.bSample ID [BPT7GW]
5.cSample ID [BK6KWY]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878245
Page 24 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/19/2021
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878246
Page 25 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/19/2021
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 [BS1NXK]
5.bSample ID [BS1S8V]
5.cSample ID [BR28WL]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878247
Page 26 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878248
Page 27 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878249
Page 28 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878250
Page 29 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878251
Page 30 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878252
Page 31 of 168
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878253
Page 32 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878254
Page 33 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878255
Page 34 of 168
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878256
Page 35 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878257
Page 36 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878258
Page 37 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878259
Page 38 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878260
Page 39 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878261
Page 40 of 168
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878262
Page 41 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878263
Page 42 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878264
Page 43 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878265
Page 44 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878266
Page 45 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878267
Page 46 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878268
Page 47 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878269
Page 48 of 168
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878270
Page 49 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878271
Page 50 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878272
Page 51 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878273
Page 52 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878274
Page 53 of 168
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878275
Page 54 of 168
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878276
Page 55 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Worsening lumbar disc h
erniation Sep/10/2020 1
0:00 NO
End Date Time:
Nov/12/2020 15:00
Repeating
Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878277
Page 56 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Worsening lumbar disc herniation]
4.Start Date Time: Sep/10/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/12/2020 15:00
6.Toxicity Grade: 3
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
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878278
Page 57 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[Unresolved chronic lumbar disc herniation. spinal surgery performed in
2013]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020414667]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878279
Page 58 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878280
Page 59 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878281
Page 60 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878282
Page 61 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878283
Page 62 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878284
Page 63 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878285
Page 64 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878286
Page 65 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878287
Page 66 of 168
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878288
Page 67 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878289
Page 68 of 168
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878290
Page 69 of 168
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878291
Page 70 of 168
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878292
Page 71 of 168
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878293
Page 72 of 168
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878294
Page 73 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878295
Page 74 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878296
Page 75 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-22-2021 20:49:56 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878297
Page 76 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-22-2021 20:49:56 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-19-2021 16:10:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta Approved Jan-21-2021 12:44:43 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-19-2021 13:49:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0878298
Page 77 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Approved Nov-13-2020 18:50:16 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 13:51:04 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-09-2020 17:31:33 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-09-2020 08:13:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-05-2020 09:11:13 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878299
Page 78 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-30-2020 19:18:31 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-30-2020 15:35:56 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-27-2020 07:49:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-26-2020 10:54:18 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878300
Page 79 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878301
Page 80 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020 10:10:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020 10:10:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878302
Page 81 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 10:10:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878303
Page 82 of 168
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 21:50:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12313783Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 21:49:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 10:10:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 10:10:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020 10:10:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878304
Page 83 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 10:11:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878305
Page 84 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclus
ive, at randomization (dep
endent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878306
Page 85 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
or 18 and 85 years, inclusive, at ra
ndomization (dependent upon stud
y stage)
1.a Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wi
th all scheduled visits, va
ccination plan, laboratory
tests, lifestyle considerati
ons, and other study proc
edures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878307
Page 86 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Inclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory t
ests, lifestyle considerations, and
other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878308
Page 87 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criter
ion De
scripti
on:Healthy participants who
are determined by medic
al history, physical exami
nation, and clinical judg
ment of the investigator t
o be eligible for inclusion
in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878309
Page 88 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Inclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physica
l examination, and clinical judgme
nt of the investigator to be eligible
for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878310
Page 89 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compl
iance with the requireme
nts and restrictions listed
in the ICD and in this pro
tocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878311
Page 90 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Inclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878312
Page 91 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or activ
e suicidal ideation/behavi
or/lab abnormality that m
ay increase the risk of stu
dy participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878313
Page 92 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepa
titis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878314
Page 93 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.b Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878315
Page 94 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with
a vaccine and/or severe a
llergic reaction (eg, anap
hylaxis) to any compone
nt of the study interventi
on(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878316
Page 95 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.c Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or s
evere allergic reaction (eg, anaphy
laxis) to any component of the stu
dy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878317
Page 96 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu8Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878318
Page 97 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
mber:
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by h
istory and/or laboratory/
physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878319
Page 98 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.e Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histo
ry and/or laboratory/physical exa
minationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878320
Page 99 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pr
olonged bleeding that wo
uld, in the opinion of the
investigator, contraindica
te intramuscular injectio
n
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878321
Page 100 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.f Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding t
hat would, in the opinion of the in
vestigator, contraindicate intramus
cular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeedingInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878322
Page 101 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breas
tfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878323
Page 102 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criterion De
scription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878324
Page 103 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic cort
icosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878325
Page 104 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.i Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxic
agents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878326
Page 105 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admin
istration or planned recei
pt throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878327
Page 106 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.j Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878328
Page 107 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
2.k
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 da
ys prior to study entry a
nd/or during study parti
cipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878329
Page 108 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.k Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies invo
lving study intervention within 28
days prior to study entry and/or d
uring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878330
Page 109 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nanop
articles
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878331
Page 110 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.m
Date Location User Value Reason
Aug-25-2020 10:12:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878332
Page 111 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the c
onduct of the study, site staff othe
rwise supervised by the investigat
or, and their respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-25-2020 10:12:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 10:11:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878333
Page 112 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878334
Page 113 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 10:13:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Kidney ston
es
Start Date: Jan/1/1961
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 10:13:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 10:13:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Kidney stonesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 10:13:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/1/1961Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 10:13:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878335
Page 114 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b
Date Location User Value Reason
Aug-25-2020 10:13:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Irritable col
on
Start Date: Jan/1/2005
Ongoing: YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878336
Page 115 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 10:13:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 18:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-27-2020 12:48:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Based on medical
history the subject is
not receiving chronic
systemic treatment
with known
immunosuppressant
medications.
Aug-27-2020 12:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened With diagnosis of
irritable colon, please
confirm if the subject
is receiving chronic
systemic treatment
with known
immunosuppressant
medications.
Aug-25-2020 10:13:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Irritable colonInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 10:13:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/1/2005Initial Entry
1.b Ongoing:
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878337
Page 116 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-25-2020 10:13:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-20-2020 13:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:L4-L5 disc her
niation
Start Date: Dec/UNK/2013
Ongoing: YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878338
Page 117 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Line/MH Number:
Date Location User Value Reason
Oct-20-2020 13:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 13:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
L4-L5 disc herniationInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-20-2020 13:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/UNK/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-20-2020 13:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-20-2020 13:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Surgical placement of
interspinous spacer at
L4-L5
Start Date
:Dec/6/2013Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878339
Page 118 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Ongoing: NO
End Date:
Dec/6/2013
1.d Line/MH Number:
Date Location User Value Reason
Oct-20-2020 13:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-20-2020 13:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Surgical placement of interspinou
s spacer at L4-L5Initial Entry
1.d Start Date:
Date Location User Value Reason
Oct-20-2020 13:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/6/2013Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-20-2020 13:16:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/6/2013Initial Entry
1.e
Date Location User Value Reason
Oct-30-2020 19:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:5Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878340
Page 119 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Medical History
Term:Arterial hypert
ension
Start Date: UNK/UNK/20
12
Ongoing: YES
Oct-29-2020 18:19:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Arterial hypert
ension
Start Date:
Ongoing:Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878341
Page 120 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Line/MH Number:
Date Location User Value Reason
Oct-29-2020 18:19:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-29-2020 18:19:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Arterial hypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-31-2020 05:05:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 19:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-30-2020 19:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
Oct-30-2020 16:02:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM Query: Data is
missing. Please
complete. Thank
you.
1.e Ongoing:
Date Location User Value Reason
Oct-30-2020 19:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878342
Page 121 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-22-2021 10:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Hypercholester
olemia
Start Date: Jun/15/2020
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Mar-22-2021 10:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-22-2021 10:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Mar-22-2021 10:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jun/15/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Mar-22-2021 10:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878343
Page 122 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
88.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878344
Page 123 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.1Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 37.1
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 10:14:53
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878345
Page 124 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878346
Page 125 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 10:15:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 10:15:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
239190Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878347
Page 126 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 10:15:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 10:15:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-24-2020 06:36:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 2: Closed Response satisfies
query
Oct-23-2020 20:03:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto
Query
Oct-23-2020 20:03:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Mabel Berrueta Data Entry:
NONew Information
Oct-23-2020 16:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened DM Q: Thank you
for your response.
Per response please
update to No and
remove date of
collection since
samples were not
processed. Thank
you.
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878348
Page 127 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-23-2020 12:59:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered On August 25, the
patient's blood
sample could not
be processed
properly, so it was
not sent to the
central laboratory
Oct-14-2020 01:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened DM : Sample is
collected on
24/Aug/2020.
However, Sample
ID is missing.
Please review and
update.
Oct-13-2020 10:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The information
was completed and
uploaded Thank
you
Oct-04-2020 04:44:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Please
confirm if response
to Sample collected
needs to be
updated to No as
the complete
process was not
done, Thank you.
Sep-29-2020 12:24:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered The patient's blood
sample could not
be processed
properly, so they
were not sent to the
central laboratory
Sep-17-2020 05:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 15:02:58
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?'
is Yes, however no
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878349
Page 128 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 01:28:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Barcode entered
Sep-15-2020 17:11:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Sep-14-2020 11:18:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thanks for
response. Kindy
add item level
comment to
explain reason for
missing barcode
stating "samples
are processed
incorrectly".
Sep-10-2020 10:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Serology samples
processed
incorrectly
Aug-25-2020 16:13:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 10:15:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 10:15:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878350
Page 129 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-23-2020 14:35:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
As stated in the medical history
, the samples could not be proc
essed, which is why they did n
ot arrive at the central laborato
ryInitial Entry
5.a
Date Location User Value Reason
Sep-16-2020 15:02:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP24RCTranscription Error
(DELETED)
Sep-15-2020 17:11:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24RCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
06:48:55
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Clos
edResponse satisfies
query
Sep-16-2020
15:02:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data E
ntry:
BP24R
CTranscription Error
(DELETED)
Sep-16-2020
15:02:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-16-2020
05:06:19ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: OpeDMW4713384;This
Barcode is already
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878351
Page 130 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00)
City of
Buenos Airesned recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Sep-15-2020
17:11:13
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
BP24R
CInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878352
Page 131 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 10:15:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 10:15:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 14:02:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 16:13:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 10:15:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 10:15:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878353
Page 132 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Sep-03-2020 14:02:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Maria del
Pilar PereyraData Entry:
Sample ID: BP24RCInitial Entry
5.a Sample ID
Date Location User ValueReason
Sep-16-2020
21:51:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-16-2020
15:03:59
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Alan Colombo Query
1: An
swere
dOriginal value is
correct
Sep-16-2020
05:06:19
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4713385;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Sep-03-2020
14:02:44
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Maria del Pilar
PereyraData
Entry
:
BP24
RCInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878354
Page 133 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020 20:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878355
Page 134 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 10:15:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878356
Page 135 of 168
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 10:15:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878357
Page 136 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020 08:07:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878358
Page 137 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878359
Page 138 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 08:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878360
Page 139 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 08:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 08:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 10:42:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 08:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-15-2020 08:07:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 10:42:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP2FVPInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878361
Page 140 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 10:42:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP2FVPInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878362
Page 141 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/14/2020 20:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878363
Page 142 of 168
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-15-2020 08:07:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878364
Page 143 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 13:25:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878365
Page 144 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 13:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 13:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 14:39:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 13:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 13:25:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 14:39:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BK6KWCInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878366
Page 145 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 14:39:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BK6KWCInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020 15:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPT7GWInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 15:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPT7GWInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 15:54:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BK6KWYInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 15:54:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BK6KWYInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878367
Page 146 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-19-2021 16:10:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/19/2021Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878368
Page 147 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-19-2021 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-19-2021 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-20-2021 12:13:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-20-2021 07:05:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-19-2021 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-19-2021 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/19/2021Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878369
Page 148 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Mar-20-2021 12:13:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS1NXKInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-20-2021 12:13:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS1NXKInitial Entry
5.b
Date Location User Value Reason
Mar-20-2021 12:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS1S8VInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-20-2021 12:14:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS1S8VInitial Entry
5.c
Date Location User Value Reason
Mar-20-2021 12:47:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR28WLInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878370
Page 149 of 168
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Mar-20-2021 12:47:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR28WLInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878371
Page 150 of 168
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878372
Page 151 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 13:49:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878373
Page 152 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021 13:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 13:49:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-19-2021 13:49:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878374
Page 153 of 168
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878375
Page 154 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-31-2020 11:49:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies query
Oct-30-2020 20:56:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies query
Oct-30-2020 11:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Oct-30-2020 11:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Oct-30-2020 11:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Worsening lumbar disc he
rniationNew Information
Oct-28-2020 07:02:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINICAL - if Progressive
Lumbar Discopathy is an
adverse event only, please
report the SAE event of
Herniated Lumbar Disc
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878376
Page 155 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
with severity = Serious on
the AE log
Oct-28-2020 06:43:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened SAE
RECON:AER#2020414667
Lumbar disc
herniation(onset
date:10Sep2020)was
reported as serious in Safety
database but missing in AE
CRF. Please confirm and
update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-27-2020 18:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Oct-27-2020 16:56:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Candidate CLINICAL - if Progressive
Lumbar Discopathy is an
adverse event only, please
report the SAE event of
Herniated Lumbar Disc
with severity = Serious on
the AE log
Oct-27-2020 09:17:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Original value is correct
Oct-27-2020 07:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020414667,
the term in AE CRF was
reported as 'progressive
lumbar discopathy' while
recorded as 'Lumbar disc
herniation' in Safety
database. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Progressive lumbar discop
athyInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878377
Page 156 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 08:49:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/10/2020 10:00Transcription Error
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/10/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 13:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 15:00New Information
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial 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
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878378
Page 157 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-04-2020 14:40:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 7: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-03-2020 11:40:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 7: Answered It is clarified that a
test for Covid was
not performed
because the adverse
event is not
associated with
Covid disease, and
the patient did not
present symptoms of
Covid disease. A
serious adverse
event follow-up
form was sent.
Nov-03-2020 02:04:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 6: Closed issued another query
Nov-03-2020 01:43:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 7: Opened Clinical – Thank
you. If NO hospital
COVID test was
performed is known,
please submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Oct-31-2020 18:46:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 6: Answered It is clarified that a
test for Covid was
not performed
because the adverse
event is not
associated with
Covid disease, in
addition the patient
did not present
symptoms of Covid
disease.
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878379
Page 158 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-31-2020 11:49:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Deleted Close Auto Query
Oct-30-2020 20:55:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 6: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020414667] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-30-2020 11:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE Worsening
lumbar disc
herniation: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-30-2020 11:05:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE Progressive
lumbar discopathy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-30-2020 11:05:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?New Information
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878380
Page 159 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
Oct-28-2020 06:40:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Oct-28-2020 06:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE Progressive
lumbar discopathy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Oct-27-2020 18:08:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-27-2020 16:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Deleted no SAE number is
present; the number
is subject ID # and
in an incorrect field
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878381
Page 160 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-27-2020 11:52:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Progressive
lumbar discopathy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Oct-27-2020 11:52:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered AE is reconsidered
as severe but not
serious.
Oct-27-2020 11:52:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOAE is reconsidered
as severe but not
serious.
Oct-25-2020 10:45:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE RECON:
Progressive lumbar
discopathy(Onset
date:10Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-25-2020 10:45:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Oct-24-2020 16:22:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Progressive
lumbar discopathy:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-24-2020 16:22:41
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESNew Information
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878382
Page 161 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
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
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878383
Page 162 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Unresolved chronic lumbar
disc herniation. spinal surge
ry performed in 2013Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 09:24:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-09-2020 08:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878384
Page 163 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-09-2020 08:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-08-2020 22:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per medical
records, subject
required surgery for
this event. Please
review this entry
and amend medical
notes, which states
that non-drug
treatment was not
required. Thank
you!
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878385
Page 164 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020 12:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Per confirmation from PSSR
during the call, outcome was
reported as
RECOVERED/RESOLVED.
Issue resolved
Nov-15-2020 17:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candida
teAwaiting update in safety
database
Nov-15-2020 11:51:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The SAE end date is NOV
12, 2020, 3:00 p m. Serious
adverse event tracking form
was sent to the sponsor on
NOV 13, 2020. Thank you
Nov-14-2020 11:05:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020414667
outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Nov-13-2020 13:51:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVE
DNew Information
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0878386
Page 165 of 168
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-19-2020 19:19:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-01-2020 09:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020414667corrected SAE
number
Oct-31-2020 11:49:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12313783Initial Entry
Oct-28-2020 06:40:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: event updated to
non serious
Oct-28-2020 06:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed updated with
correct AER
Oct-28-2020 06:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated with
correct AER
Oct-28-2020 06:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020414667updated with
correct AER
Oct-27-2020 16:52:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical - please
remove this
number; it is the
subject ID and not
a SAE number.
Currently, this
event is coded as
NOT SERIOUS
Oct-27-2020 07:49:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12313783Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878387
Page 166 of 168
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021 13:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 13:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0878388
Page 167 of 168
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020 10:15:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-25-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-12-2020 13:26:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-25-2020 10:15:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
Aug-25-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0878389
Page 168 of 168
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313783 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 10:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2ecf\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878390