Document text
Page 1 of 295
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497164
Page 2 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/7/2021
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497165
Page 3 of 295
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11561357]
2.Birth Date: 2008
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497166
Page 4 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497167
Page 5 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497168
Page 6 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/7/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497169
Page 7 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[REFRACTIVE AMBLYOPIA (RIGHT EYE)]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[PREMENARCHAL]
Start Date: 2008
Ongoing: YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497170
Page 8 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497171
Page 9 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/7/2021
2.Weight: [40.95]
3.Unit: kg
4.Height: [160.5]
5.Unit: cm
6.Body Mass Index: [15.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497172
Page 10 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497173
Page 11 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/7/2021
2.Randomization Number: [26052]
3.Randomization Group: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497174
Page 12 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR3NJV]
5.bSample ID [BS608W]
5.cSample ID [BS608V]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497175
Page 13 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [BR3NK5]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497176
Page 14 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/7/2021 17:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497177
Page 15 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497178
Page 16 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497179
Page 17 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497180
Page 18 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497181
Page 19 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497182
Page 20 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/27/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497183
Page 21 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497184
Page 22 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BR38VN]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497185
Page 23 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/27/2021 16:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497186
Page 24 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497187
Page 25 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497188
Page 26 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497189
Page 27 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497190
Page 28 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [BRLYBC]
5.bSample ID [BS2F7Y]
5.cSample ID [BS2F7X]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497191
Page 29 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497192
Page 30 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497193
Page 31 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497194
Page 32 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497195
Page 33 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497196
Page 34 of 295
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497197
Page 35 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497198
Page 36 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497199
Page 37 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497200
Page 38 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497201
Page 39 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497202
Page 40 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497203
Page 41 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497204
Page 42 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497205
Page 43 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497206
Page 44 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497207
Page 45 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497208
Page 46 of 295
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497209
Page 47 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497210
Page 48 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497211
Page 49 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BR38W5]
5.bSample ID [BS60H8]
5.cSample ID [BS60H7]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497212
Page 50 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BR38WF]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497213
Page 51 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497214
Page 52 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
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 [AA11000]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497215
Page 53 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497216
Page 54 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
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 [AA10955]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497217
Page 55 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497218
Page 56 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
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 [AA10965]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497219
Page 57 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/24/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK8
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497220
Page 58 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/24/2021
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 [AA10954]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497221
Page 59 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/19/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK12
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497222
Page 60 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/19/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/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 [AA40645]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497223
Page 61 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on May/03/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/3/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK14
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497224
Page 62 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on May/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/3/2021
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 [AA40190]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497225
Page 63 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/13/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK16
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497226
Page 64 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 7 -
Unscheduled Visit on May/13/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/13/2021
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 [AA40644]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497227
Page 65 of 295
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497228
Page 66 of 295
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497229
Page 67 of 295
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497230
Page 68 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497231
Page 69 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 APPENDI
CITIS Jun/10/2021 U
NK:UNK NO
End Date Time:
Jun/10/2021 UNK:
UNK
Repeating
Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497232
Page 70 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[APPENDICITIS]
4.Start Date Time: Jun/10/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/10/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497233
Page 71 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497234
Page 72 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021749538]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497235
Page 73 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497236
Page 74 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497237
Page 75 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497238
Page 76 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497239
Page 77 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497240
Page 78 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497241
Page 79 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497242
Page 80 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497243
Page 81 of 295
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497244
Page 82 of 295
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497245
Page 83 of 295
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/13/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497246
Page 84 of 295
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497247
Page 85 of 295
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497248
Page 86 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/17/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497249
Page 87 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
May/17/2021
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497250
Page 88 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497251
Page 89 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :May/17/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497252
Page 90 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497253
Page 91 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/17/2021
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 [BT9SJ7]
5.bSample ID [BKH913]
5.cSample ID [BKH912]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497254
Page 92 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
May/17/2021
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 [BT9SJ1]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497255
Page 93 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: May/17/2021 17:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497256
Page 94 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/7/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497257
Page 95 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497258
Page 96 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jun/7/2021
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 [BT9SMV]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497259
Page 97 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jun/7/2021 10:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497260
Page 98 of 295
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/6/2021
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497261
Page 99 of 295
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Jul/6/2021
3.Comments: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497262
Page 100 of 295
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497263
Page 101 of 295
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497264
Page 102 of 295
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497265
Page 103 of 295
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497266
Page 104 of 295
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jul/6/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497267
Page 105 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Feb/25/2021
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497268
Page 106 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497269
Page 107 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Jul-08-2021 15:28:24 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497270
Page 108 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-08-2021 13:00:46 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497271
Page 109 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497272
Page 110 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497273
Page 111 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497274
Page 112 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497275
Page 113 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497276
Page 114 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497277
Page 115 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497278
Page 116 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497279
Page 117 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-08-2021 13:02:21 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497280
Page 118 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497281
Page 119 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497282
Page 120 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497283
Page 121 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497284
Page 122 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497285
Page 123 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497286
Page 124 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497287
Page 125 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497288
Page 126 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJan-28-2021 15:37:18 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497289
Page 127 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-18-2021 10:56:11 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497290
Page 128 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497291
Page 129 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1May-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497292
Page 130 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2May-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497293
Page 131 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3May-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497294
Page 132 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4May-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497295
Page 133 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5May-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497296
Page 134 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aMay-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497297
Page 135 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aMay-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497298
Page 136 of 295
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aMay-18-2021 10:57:52 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497299
Page 137 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497300
Page 138 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497301
Page 139 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497302
Page 140 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497303
Page 141 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497304
Page 142 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497305
Page 143 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497306
Page 144 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497307
Page 145 of 295
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aJun-07-2021 14:56:17 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497308
Page 146 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Jul-08-2021 15:28:24 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Jul-07-2021 16:23:17 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jun-25-2021 11:43:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497309
Page 147 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Jun-25-2021 11:41:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jun-23-2021 12:50:13 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497310
Page 148 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Hector
Aguilar N/A Jun-22-2021 10:14:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jun-08-2021 14:26:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Jun-07-2021 14:55:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved May-18-2021 15:04:48 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497311
Page 149 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A May-18-2021 10:55:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved May-15-2021 22:21:28 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497312
Page 150 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Hector
Aguilar N/A May-13-2021 15:04:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved May-10-2021 12:52:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A May-07-2021 13:53:04 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Apr-21-2021 14:22:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497313
Page 151 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector
Aguilar N/A Apr-20-2021 16:17:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Mar-31-2021 14:27:53 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497314
Page 152 of 295
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Hector
Aguilar N/A Mar-30-2021 15:27:51 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Mar-23-2021 23:11:18 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497315
Page 153 of 295
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-08-2021
12:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-08-2021
12:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497316
Page 154 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-08-2021
12:59:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obta
ined
Jan/7/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497317
Page 155 of 295
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-08-2021 12:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11561357Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-08-2021 12:57:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2008Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-08-2021
12:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-08-2021
12:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH O
RIGINInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497318
Page 156 of 295
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-08-2021
12:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
WHITEInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497319
Page 157 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021
13:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/7/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497320
Page 158 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-08-2021
13:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-08-2021 13:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-08-2021
13:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497321
Page 159 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-08-2021 13:01:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:REFRACTIVE A
MBLYOPIA (RIG
HT EYE)
Start Dat
e:UNK/UNK/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-08-2021 13:01:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-08-2021
13:01:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
REFRACTIVE AMBLYOPI
A (RIGHT EYE)Initial Entry
1.a Start Date:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497322
Page 160 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-08-2021
13:01:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-19-2021
15:37:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Hayley
WyperQuery 1: Closed Response satisfies
query
Jan-19-2021
12:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Hector
AguilarQuery 1: Answered SUBJECT IS
PREMENARCHAL.
DIAGNOSIS HAS
BEEN ADDED TO
MEDICAL
HISTORY.
Jan-15-2021
07:34:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Hayley
WyperQuery 1: Opened CLINQUERY: All
females <60 require
a pregnancy test
unless there is a MH
entry confirming not
of childbearing
potential. Please
review why a test
was not performed;
add an entry to the
MH to clarify
non-chilbearing
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497323
Page 161 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
status per CCG 8.7
Jan-08-2021
13:01:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-19-2021 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:PREMENA
RCHAL
Start Date: /2008
Ongoing: YESInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497324
Page 162 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Jan-19-2021 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-19-2021
12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
PREMENARCHALInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-19-2021
12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-19-2021
12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YESInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0497325
Page 163 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-08-2021
13:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497326
Page 164 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/7/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
40.95Initial Entry
3. Unit:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Jan-08-2021
13:02:09ACV0PF
EINFP60Hector
AguilarData Entry:
160.5Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497327
Page 165 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Unit:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-08-2021 13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
15.9Initial Entry
7.a
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Record Identifi
er::1
Temperature: 98.2
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497328
Page 166 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jan-08-2021
13:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497329
Page 167 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-08-2021
13:02:21ACV0PF
EINFP60Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497330
Page 168 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Specimen Type:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497331
Page 169 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
6.a Test:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-08-2021
13:02:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497332
Page 170 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-08-2021
13:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/7/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-08-2021
13:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
26052Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497333
Page 171 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 13:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021
13:28:16
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-08-2021
13:28:06
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497334
Page 172 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-08-2021
13:28:06
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021
13:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BR3NJVInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-08-2021
13:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BR3NJVInitial Entry
5.b
Date Location User Value Reason
Jan-08-2021
13:39:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS608WInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497335
Page 173 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-08-2021
13:39:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS608WInitial Entry
5.c
Date Location User Value Reason
Jan-08-2021
13:40:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS608VInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-08-2021
13:40:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS608VInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497336
Page 174 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 13:46:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 13:46:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021
13:46:10
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-08-2021
13:46:01
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497337
Page 175 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-08-2021
13:46:01
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021
13:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BR3NK5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-08-2021
13:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BR3NK5Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497338
Page 176 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021
13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021
13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/7/2021 17:03Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497339
Page 177 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021
13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-08-2021 13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497340
Page 178 of 295
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-08-2021
13:03:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YESInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497341
Page 179 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jan-08-2021
13:03:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497342
Page 180 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021
15:37:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/27/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497343
Page 181 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: FE
V
ER
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FEVERInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497344
Page 182 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497345
Page 183 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497346
Page 184 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497347
Page 185 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497348
Page 186 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497349
Page 187 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497350
Page 188 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497351
Page 189 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-28-2021 15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
LEFTInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497352
Page 190 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
5.b
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497353
Page 191 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497354
Page 192 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-28-2021
15:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497355
Page 193 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/27/2021Initial Entry
2.a
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Record Identifi
er::1
Temperature: 97.3
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
1Initial Entry
2.a Temperature:
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497356
Page 194 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-28-2021
15:37:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497357
Page 195 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-28-2021
15:37:18ACV0PF
EINFP60Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497358
Page 196 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Specimen Type:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497359
Page 197 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
6.a Test:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-28-2021
15:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497360
Page 198 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 11:38:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 11:38:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021
11:38:56
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-29-2021
11:38:49
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497361
Page 199 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
11:38:49
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021
11:38:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BR38VNInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-29-2021
11:38:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BR38VNInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497362
Page 200 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-28-2021
15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-28-2021 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-28-2021
15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/27/2021 16:03Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497363
Page 201 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021
15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-28-2021 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497364
Page 202 of 295
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-28-2021
15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YESInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497365
Page 203 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
17:33:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Feb/25/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497366
Page 204 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: FE
V
ER
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FEVERInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497367
Page 205 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497368
Page 206 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497369
Page 207 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497370
Page 208 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497371
Page 209 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497372
Page 210 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497373
Page 211 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497374
Page 212 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-25-2021
17:34:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
LEFTInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497375
Page 213 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
5.b
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497376
Page 214 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497377
Page 215 of 295
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the
Subject Diary was
completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-25-2021
17:34:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NOInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497378
Page 216 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
17:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
17:34:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
11:32:53
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-26-2021
06:08:25
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2022-5812-0497379
Page 217 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-25-2021
17:34:51
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-25-2021
17:34:51
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
11:32:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BRLYBCInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
11:32:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BRLYBCInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497380
Page 218 of 295
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b
Date Location User Value Reason
Feb-26-2021
11:36:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS2F7YInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
11:36:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS2F7YInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021
11:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS2F7XInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
11:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS2F7XInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497381
Page 219 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021
15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Jan/28/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497382
Page 220 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-28-2021
15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obta
ined
Jan/28/2021Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497383
Page 221 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 11:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021
11:23:49
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-29-2021
11:23:40
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497384
Page 222 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
11:23:40
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021
11:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BR38W5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-29-2021
11:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BR38W5Initial Entry
5.b
Date Location User Value Reason
Jan-29-2021
11:27:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS60H8Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497385
Page 223 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-29-2021
11:27:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS60H8Initial Entry
5.c
Date Location User Value Reason
Jan-29-2021
11:28:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BS60H7Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021
11:28:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BS60H7Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497386
Page 224 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 11:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 11:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021
11:38:07
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-29-2021
11:37:57
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
FDA-CBER-2022-5812-0497387
Page 225 of 295
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-29-2021
11:37:57
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021
11:38:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: BR38WFInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-29-2021
11:38:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
BR38WFInitial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497388
Page 226 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
12:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Feb/9/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-26-2021
12:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
SSWAB_WEEK2Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497389
Page 227 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
12:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
12:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
12:41:27
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
12:41:15
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497390
Page 228 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-26-2021
12:41:15
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
12:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: AA11000Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
12:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
AA11000Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497391
Page 229 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
11:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Feb/24/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-26-2021
11:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
SSWAB_WEEK4Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497392
Page 230 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
11:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
11:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
11:58:23
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
11:58:00
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497393
Page 231 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-26-2021
11:58:00
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
11:58:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: AA10955Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
11:58:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
AA10955Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497394
Page 232 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
10:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Mar/10/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-12-2021
10:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
SSWAB_WEEK6Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497395
Page 233 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
10:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
10:55:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
10:55:42
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
10:55:15
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497396
Page 234 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Mar-12-2021
10:55:15
(UTC-05:00) Eastern
Time (US &
Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
10:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Sample ID: AA10965Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
10:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
AA10965Initial Entry
090177e19891a045\Final\Final On: 11-Nov-2021 01:21 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0497397
Page 235 of 295
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Mar/24/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561357 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-30-2021
15:27:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Hector
AguilarData Entry:
Mar/24/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Locatio
…[truncated]