Document text
Page 1 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869250
Page 2 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869251
Page 3 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12312687]
2.Birth Date: /1972
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869252
Page 4 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869253
Page 5 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869254
Page 6 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869255
Page 7 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869256
Page 8 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869257
Page 9 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869258
Page 10 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [101.25]
3.Unit: kg
4.Height: [163.0]
5.Unit: cm
6.Body Mass Index: [38.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869259
Page 11 of 221
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869260
Page 12 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [59573]
3.Randomization Group: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869261
Page 13 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXW5W]
5.bSample ID [BHXW5X]
5.cSample ID [BHXW5Y]
5.dSample ID [BJ491K]
5.eSample ID [BJ491L]
5 fSample ID [BJ491M]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869262
Page 14 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXW1S]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869263
Page 15 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/20/2020 18:20
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869264
Page 16 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869265
Page 17 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869266
Page 18 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869267
Page 19 of 221
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869268
Page 20 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample BP1Z05 was destroyed as V2 was not completed that day and had to be
rescheduled.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1Z05]
5.bSample ID [BPWTCS]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869269
Page 21 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/22/2020 19:05
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
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869270
Page 22 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869271
Page 23 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BJ50W2]
5.bSample ID [BPW7LN]
5.cSample ID [BJ50W3]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869272
Page 24 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869273
Page 25 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/12/2021
2.Date of First Symptom Started: Mar/8/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/14/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869274
Page 26 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.aSymptoms - Other Text: [rhinorrhea]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869275
Page 27 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Col
lectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Mar/12/202
1 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869276
Page 28 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Mar/12/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869277
Page 29 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected by a team physician.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869278
Page 30 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
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 [BR2204]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869279
Page 31 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869280
Page 32 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869281
Page 33 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869282
Page 34 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[pharyngitis]
Date of Diagnosis:
Mar/12/2021
3.Toxicity Grade: 1
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869283
Page 35 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869284
Page 36 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869285
Page 37 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869286
Page 38 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869287
Page 39 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869288
Page 40 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869289
Page 41 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869290
Page 42 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869291
Page 43 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869292
Page 44 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869293
Page 45 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869294
Page 46 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: OXYGENATION PARAMETERS
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869295
Page 47 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869296
Page 48 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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.Start Date: //
6.Ongoing?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869297
Page 49 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869298
Page 50 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869299
Page 51 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869300
Page 52 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869301
Page 53 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869302
Page 54 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869303
Page 55 of 221
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869304
Page 56 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869305
Page 57 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869306
Page 58 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869307
Page 59 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869308
Page 60 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869309
Page 61 of 221
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869310
Page 62 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869311
Page 63 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869312
Page 64 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869313
Page 65 of 221
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869314
Page 66 of 221
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 per other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869315
Page 67 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869316
Page 68 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869317
Page 69 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869318
Page 70 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869319
Page 71 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/25/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869320
Page 72 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRZ1HY]
5.bSample ID [BR1ZTW]
5.cSample ID [BRZ1K8]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869321
Page 73 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BR28LM]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869322
Page 74 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 18:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869323
Page 75 of 221
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/19/2021
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869324
Page 76 of 221
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/19/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869325
Page 77 of 221
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BRN0RZ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869326
Page 78 of 221
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/19/2021 15:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869327
Page 79 of 221
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869328
Page 80 of 221
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869329
Page 81 of 221
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869330
Page 82 of 221
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869331
Page 83 of 221
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869332
Page 84 of 221
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869333
Page 85 of 221
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869334
Page 86 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Myalgia on internal area of left a
rm Feb/26/2021 0
8:00 NO
End Date Time:
Mar/8/2021 08:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Adenopathy in the left supraclavi
cular area Feb/27/2021 0
9:00 NO
End Date Time:
Mar/7/2021 21:00
Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869335
Page 87 of 221
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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)[Myalgia on internal area of left arm]
4.Start Date Time: Feb/26/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/8/2021 08:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869336
Page 88 of 221
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869337
Page 89 of 221
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Adenopathy in the left supraclavicular area]
4.Start Date Time: Feb/27/2021 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/7/2021 21:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869338
Page 90 of 221
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869339
Page 91 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869340
Page 92 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869341
Page 93 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869342
Page 94 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: //
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869343
Page 95 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869344
Page 96 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869345
Page 97 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869346
Page 98 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869347
Page 99 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869348
Page 100 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869349
Page 101 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869350
Page 102 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869351
Page 103 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869352
Page 104 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/8/2020
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869353
Page 105 of 221
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869354
Page 106 of 221
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0869355
Page 107 of 221
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormAug-21-2020 08:40:37 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0869356
Page 108 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormFeb-26-2021 11:20:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869357
Page 109 of 221
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-19-2021 17:03:25 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack Approved Mar-19-2021 11:33:31 (UTC-03:00) City of
Buenos AiresBOOK Signed
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.
N/A Mar-18-2021 11:11:57 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-17-2021 16:19:35 (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-10-2021 17:51:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869358
Page 110 of 221
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
N/A
Approved Mar-08-2021 17:58:31 (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 Feb-26-2021 11:19:59 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-22-2021 17:55:42 (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 Feb-17-2021 10:26:50 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-15-2020 10:32:34 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0869359
Page 111 of 221
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 09:26:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 17:13:12 (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.
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869360
Page 112 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020 08:39:22
(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-21-2020 08:39:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869361
Page 113 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020 08:39:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869362
Page 114 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 17:43:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12312687Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 17:42:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020 08:39:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020 08:39:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 08:39:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869363
Page 115 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020 08:39:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869364
Page 116 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 ye
ars, inclusive, at randomizatio
n (dependent upon study stage
)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 y
ears, inclusive, at randomization (depe
ndent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869365
Page 117 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Desc
ription:Participants who are willing
and able to comply with all s
cheduled visits, vaccination p
lan, laboratory tests, lifestyle
considerations, and other stu
dy procedures
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN02A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869366
Page 118 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Inclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyle
considerations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inves
tigator to be eligible for inclu
sion in the studyInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869367
Page 119 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determine
d by medical history, physical examinat
ion, and clinical judgment of the invest
igator to be eligible for inclusion in the
studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu4Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869368
Page 120 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
mber:
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restricti
ons listed in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed infor
med consent, which includes complian
ce with the requirements and restriction
s listed in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869369
Page 121 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal id
eation/behavior/lab abnormali
ty that may increase the risk o
f study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorma
lity that may increase the risk of study
participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869370
Page 122 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (
HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869371
Page 123 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Known infection with human immunod
eficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)
Criteri
on met
?:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869372
Page 124 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on ID: (
For Pfi
zer use
only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction asso
ciated with a vaccine and/or severe alle
rgic reaction (eg, anaphylaxis) to any c
omponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869373
Page 125 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:8Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869374
Page 126 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterio
n Descri
ption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinatio
n
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency,
as determined by history and/or laborat
ory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869375
Page 127 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:10
Criterio
n Descr
iption:Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular inj
ection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869376
Page 128 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition associa
ted with prolonged bleeding that would
, in the opinion of the investigator, cont
raindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869377
Page 129 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.g Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfeed
ingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869378
Page 130 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.h Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any coronavi
rus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:13
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, su
ch as cytotoxic agents or s
ystemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869379
Page 131 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppressi
ve therapy, such as cytotoxic agents or
systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descr
iption:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study inte
rvention administration or pl
anned receipt throughout the
study
Criterio
n met?:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869380
Page 132 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stu
dy intervention administration or plann
ed receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869381
Page 133 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studie
s involving study interventi
on within 28 days prior to s
tudy entry and/or during stu
dy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869382
Page 134 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study parti
cipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in o
ther studies involving stud
y intervention containing l
ipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869383
Page 135 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion
ID: (For P
fizer use o
nly):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studies i
nvolving study intervention containing
lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:22Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869384
Page 136 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criteri
on Des
criptio
n:Investigator site staff or Pfize
r employees directly involved
in the conduct of the study, si
te staff otherwise supervised
by the investigator, and their
respective family members
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervise
d by the investigator, and their respecti
ve family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-21-2020 08:40:17
(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-21-2020 08:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869385
Page 137 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 08:40:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 08:40:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 08:40:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869386
Page 138 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
101.25Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
163.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
38.1Initial Entry
7.a
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869387
Page 139 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 08:41:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869388
Page 140 of 221
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869389
Page 141 of 221
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-21-2020 08:41:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869390
Page 142 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 08:41:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 08:41:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
59573Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869391
Page 143 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 08:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 08:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 15:30:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 10:05:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Balaji
Prabu RQuery 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-21-2020 08:42:10
(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-21-2020 08:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 15:30:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXW5WInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869392
Page 144 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 15:30:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHXW5WInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 15:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXW5XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020 15:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHXW5XInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 15:31:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXW5YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020 15:31:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHXW5YInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020 18:31:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ491KInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869393
Page 145 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.d Sample ID
Date Location User Value Reason
Aug-24-2020 18:31:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ491KInitial Entry
5.e
Date Location User Value Reason
Aug-24-2020 18:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ491LInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020 18:31:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ491LInitial Entry
5.f
Date Location User Value Reason
Aug-24-2020 18:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ491MInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-24-2020 18:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ491MInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869394
Page 146 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 08:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 08:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 18:45:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 10:05:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Balaji
Prabu RQuery 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-21-2020 08:42:17
(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-21-2020 08:42:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 18:45:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHXW1SInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869395
Page 147 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 18:45:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BHXW1SInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869396
Page 148 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/20/2020 18:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869397
Page 149 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Aug-21-2020 08:42:34
(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-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-21-2020 08:42:34
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869398
Page 150 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-21-2020 08:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869399
Page 151 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 08:25:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Sep-28-2020 12:20:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Original value is
correct
Sep-28-2020 11:32:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Another query
already present.
Sep-28-2020 08:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of window
(10 day) from DOV
(20/Aug/2020) at
V1D1VX1L. Please
either update DOV or
confirm whether visit
is out of window due
to temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-27-2020 13:05:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-27-2020 13:05:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Transcription Error
Sep-26-2020 10:40:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete
‘Vaccination form' at
this visit. Thank you.
Sep-09-2020 17:49:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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)
FDA-CBER-2021-5683-0869400
Page 152 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 12:20:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-28-2020 12:20:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Transcription Error
Sep-27-2020 13:05:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Vital signs Date
09/Sep/2020 is not
same as Date of Visit
22/Sep/2020. Please
review and update as
appropriate or clarify.
Sep-09-2020 17:49:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020 12:20:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYTranscription Error
Sep-09-2020 17:49:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 37.3
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 17:49:31
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869401
Page 153 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 12:20:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Transcription Error
Sep-09-2020 17:49:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
37.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 17:49:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 17:49:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869402
Page 154 of 221
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020 12:20:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-28-2020 12:20:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Transcription Error
Sep-27-2020 13:05:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Collection Date
09/Sep/2020 is not the
same as the Date of
Visit 22/Sep/2020.
Please correct or
confirm.
Sep-09-2020 17:49:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869403
Page 155 of 221
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 17:49:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869404
Page 156 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 17:50:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 17:50:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-14-2020 11:31:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Nov-13-2020 16:23:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Query 5: Answered Sample BP1Z05 was
destroyed as V2 was
not completed that
day and had to be
rescheduled.
Nov-13-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Deleted barcode entered
Nov-13-2020 09:26:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 5: Opened There are more than 1
barcode present for
sample collection.
Please review and
correct as appropriate.
Nov-11-2020 16:31:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Candidate DM: Do not issue
query. Query can be
closed after barcode
BP1Z05 is entered.
Oct-26-2020 08:22:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869405
Page 157 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-23-2020 15:50:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered Original value is
correct
Oct-22-2020 14:31:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened LIMS: Thanks for
your response. Please
consider reporting all
barcodes for this visit,
including destroyed
barcodes. Please
review and update or
submit SCF.
Oct-22-2020 13:12:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered Original value is
correct
Oct-22-2020 06:34:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened LIMS 2: Please
consider reporting all
barcodes taken for
this visit including
destructed samples
since it was received
by the lab or submit
SCF.
Oct-21-2020 17:14:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered The BP1Z05 code has
been destroyed by the
laboratory so the
BPWTCS code is
correct
Oct-21-2020 10:47:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened LIMS 1: Thanks for
your response. Nasal
swab barcode
BP1Z05 was received
by the lab for
12312687 at visit 2. If
more than 1 barcode
was collected at this
visit, please consider
entering all in inform.
If not, please submit
updated SCF.
Oct-21-2020 09:34:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraQuery 3: Answered Sample uploaded is
correct. Does not
apply the other
sample.
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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) (4)
FDA-CBER-2021-5683-0869406
Page 158 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-20-2020 02:35:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened LIMS RQ : Nasal
Swab barcode
BP1Z05 was received
by the lab for visit 2
However, BPWTCS
is recorded. please
consider reporting all
barcodes taken for
this visit including
destructed samples
since it was received
by the lab or submit
SCF.
Oct-19-2020 17:56:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Query 3: Answered Original value is
correct
Oct-19-2020 11:06:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened LIMS Query: Nasal
Swab barcode
BP1Z05 was received
by lab for visit 2.
Please review and
update accordingly
with all barcodes or
submit SCF with
correct subject
associated with the
barcode.
Sep-28-2020 09:56:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-28-2020 09:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened There are more than 1
barcode present for
sample collection.
Please review and
correct as appropriate.
Sep-28-2020 09:55:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
YES
Date of Collection:
Sep/22/2020Transcription Error
Sep-10-2020 11:15:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869407
Page 159 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-10-2020 02:11:41
(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.
Sep-09-2020 17:50:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Transcription Error
Sep-09-2020 17:50:21
(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.
Sep-09-2020 17:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-13-2020 09:32:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample BP1Z05 was destroyed as V2
was not completed that day and had to
be rescheduled.Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 09:26:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1Z05Transcription Error
Sep-28-2020 09:56:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1Z05Transcription Error
(DELETED)
Sep-10-2020 11:15:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1Z05Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869408
Page 160 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Nov-13-2020 09:26:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1Z05Transcription Error
Sep-28-2020 09:56:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1Z05Transcription Error
(DELETED)
Sep-10-2020 11:15:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1Z05Initial Entry
5.b
Date Location User Value Reason
Sep-28-2020 09:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPWTCSInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869409
Page 161 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 10:30:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-27-2020 18:46:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered sample does not
apply
Oct-27-2020 15:22:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened LIMS1: Nasal swab
barcode BP1Z05 was
received by the lab
for visit 2. Please
consider reporting all
barcodes associated
with this visit
including destroyed
samples or submit an
updated SCF.
Oct-27-2020 11:21:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-27-2020 11:12:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened LIMS: Nasal swab
barcode BP1Z05 and
BPWTCS was
received by the lab
for visit 2. Please
consider reporting all
barcodes associated
with this visit
including destroyed
samples or submit an
updated SCF.
Sep-28-2020 09:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPWTCSInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869410
Page 162 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020 19:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869411
Page 163 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Sep-28-2020 12:19:29
(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-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-28-2020 12:19:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869412
Page 164 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-13-2020
02:59:46
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Clo
sedAs per site confirmation -
updated PD tracker
Oct-12-2020
11:50:07
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Ans
weredOriginal value is correct
Oct-09-2020
11:31:21
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dPDQ RQ1: Thank you for the
response. However date of
visit has not been updated
please either update or else
confirm visit occurred out of
window on 8Octt2020,
Oct-09-2020
08:36:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query
1: Ans
weredThe information was uploaded
Thank you
Oct-09-2020
08:15:43
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for -12 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Oct-08-2020
12:28:28
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Oct/8/
2020Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4)
(b) (4)
FDA-CBER-2021-5683-0869413
Page 165 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 12:28:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 12:28:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 12:28:35
(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-08-2020 12:28:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ50W2Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869414
Page 166 of 221
***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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Oct-08-2020 16:11:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ50W2Initial Entry
5.b
Date Location User Value Reason
Oct-08-2020 17:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPW7LNInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 17:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPW7LNInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 19:35:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BJ50W3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 19:35:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BJ50W3Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869415
Page 167 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-13-2021 11:37:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-13-2021 11:36:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-13-2021 11:35:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Mar-13-2021 11:35:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Mar-13-2021 11:35:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-13-2021 11:35:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869416
Page 168 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-18-2021 11:11:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Mar/14/2021New Information
Mar-13-2021 11:36:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869417
Page 169 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869418
Page 170 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.c Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869419
Page 171 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.e Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE PA
INInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
SORE THROATInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869420
Page 172 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Symptom
Present:YES
4.g Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869421
Page 173 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.i Symptoms:
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-13-2021 11:36:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Mar-13-2021 11:36:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: rhinorrheaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Mar-13-2021 11:36:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
rhinorrheaInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869422
Page 174 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869423
Page 175 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP COVID
-19 DETECTION KITInitial Entry
7. Test Result:
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869424
Page 176 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Mar-13-2021 11:37:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869425
Page 177 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-13-2021 11:37:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-13-2021 11:37:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-13-2021 11:37:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-13-2021 11:37:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample collected by a team physician.Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869426
Page 178 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-13-2021 11:37:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-13-2021 11:37:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-15-2021 11:22:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-14-2021 08:09:39
(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-13-2021 11:37:54
(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-13-2021 11:37:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-15-2021 11:22:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BR2204Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869427
Page 179 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Mar-15-2021 11:22:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BR2204Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0869428
Page 180 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869429
Page 181 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT C
AREInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869430
Page 182 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Occurrence of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:TELEPHONE C
ONSULTATION
Occurrence of Vis
its or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-13-2021 11:38:05 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869431
Page 183 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of Buenos
AiresType of Practitioner: OTHE
R
Occurrence of Visits or Con
tacts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-13-2021 11:38:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869432
Page 184 of 221
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Mar/12/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Mar-13-2021 11:38:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-13-2021 11:38:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
pharyngitis
Date of Diagnosis:
Mar/12/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-13-2021 11:38:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869433
Page 185 of 221
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 18:13:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-20-2020 19:28:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered By mistake, the
volunteer is
summoned to her visit
3 on the day
08-October-2020 out
of window. Although
the volunteer is
explained the need to
attend again on the
appropriate date, she
requests for
convenience that said
visit be considered as
her visit 3.
Oct-20-2020 19:28:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/8/2020By mistake, the
volunteer is
summoned to her visit
3 on the day
08-October-2020 out
of window. Although
the volunteer is
explained the need to
attend again on the
appropriate date, she
requests for
convenience that said
visit be considered as
her visit 3.
Oct-13-2020 10:12:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination visit
after the 2nd
vaccination. Please
update date of EOT to
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869434
Page 186 of 221
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
match the date the
Visit 3(1 month) visit
was completed.
Oct-09-2020 08:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
Sep-28-2020 12:21:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Changed Information
Sep-10-2020 11:07:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 08:36:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Sep-28-2020 12:21:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed Information
Sep-10-2020 11:07:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 08:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
Sep-28-2020 12:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-28-2020 12:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Changed Information
Sep-28-2020 12:21:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status" is
NO LONGER MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869435
Page 187 of 221
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
missing.
Sep-10-2020 11:07:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO LONGER MEETS ELIGIBILITY
CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-28-2020 12:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-28-2020 12:21:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Sep-28-2020 12:21:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry: Changed Information
Sep-23-2020 17:36:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY: Thank
you for your response.
As indicated in section
7.1, a positive
SARS-CoV-2 NAAT
result without
symptoms should not
result in
discontinuation of
study intervention.
Please confirm patient
was asymptomatic
Sep-19-2020 20:03:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The subject was
discontinued for being
COVID-19 positive, in
continuous forms with
follow-up, without
receiving the 2nd
vaccine. Thank you.
Sep-17-2020 21:31:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY: Per
protocol positive
SARS-CoV-2 NAAT
result WITHOUT
SYMPTOMS should
not result in
discontinuation of
study intervention.
Please continue as per
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (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-2021-5683-0869436
Page 188 of 221
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
protocol and complete
the COVID Illness
CRF form if result
from local lab.
Sep-10-2020 11:07:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous clinical or microbiological
diagnosis of COVID-19Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869437
Page 189 of 221
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 10:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869438
Page 190 of 221
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-17-2021 10:27:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-17-2021 10:27:04
(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.
Feb-17-2021 10:27:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per other protocol allowan
ce(s) and confirmed to have receiv
ed only placebo at Vaccination 1/2Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0869439
Page 191 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 11:19:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869440
Page 192 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-26-2021 11:20:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/25/2021Initial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869441
Page 193 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-26-2021 11:20:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-26-2021 11:20:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-26-2021 11:20:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2e5d\Final\Final On: 01-Apr-2021 03:10 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0869442
Page 194 of 221
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312687 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-26-2021 11:20:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-26-2021 11:20:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Da
…[truncated]