Document text
Page 1 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932241
Page 2 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932242
Page 3 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11251020]
2.Birth Date: 1974
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:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932243
Page 4 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932244
Page 5 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932245
Page 6 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932246
Page 7 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932247
Page 8 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Caesarean section]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Nexplanon placement]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932248
Page 9 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [212.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [32.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932249
Page 10 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/13/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932250
Page 11 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [48757]
3.Randomization Group: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932251
Page 12 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP52KZ]
5.bSample ID [BP52L0]
5.cSample ID [BP52L1]
5.dSample ID [BPR88M]
5.eSample ID [BPR88N]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932252
Page 13 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP52KY]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932253
Page 14 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/13/2020 12:17
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
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932254
Page 15 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932255
Page 16 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932256
Page 17 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932257
Page 18 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932258
Page 19 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932259
Page 20 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932260
Page 21 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932261
Page 22 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKMKXT]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932262
Page 23 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 15:16
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
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932263
Page 24 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932264
Page 25 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932265
Page 26 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932266
Page 27 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932267
Page 28 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM5J0T]
5.bSample ID [BM5J0V]
5.cSample ID [BPR8P5]
5.dSample ID [BS7TPL]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932268
Page 29 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932269
Page 30 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932270
Page 31 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932271
Page 32 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932272
Page 33 of 250
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932273
Page 34 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932274
Page 35 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932275
Page 36 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932276
Page 37 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932277
Page 38 of 250
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932278
Page 39 of 250
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932279
Page 40 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932280
Page 41 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932281
Page 42 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932282
Page 43 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 traumatic brai
n injury Dec/23/2020
UNK:UNK NO
End Date Time:
Jan/21/2021 UNK:
UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Skull Fractur
e Dec/23/2020
UNK:UNK NO
End Date Time:
Jan/21/2021 UNK:
UNK
Repeating
Pages
3.ADVERSE
EVENT 3 Cervical Spin
e fracture Dec/23/2020
UNK:UNK NO
End Date Time:
Jan/21/2021 UNK:
UNK
Repeating
Pages
4.ADVERSE
EVENT 4 Rib Fractures Dec/23/2020
UNK:UNK NO
End Date Time:
Jan/21/2021 UNK:
UNK
Repeating
Pages
5.ADVERSE
EVENT 5 Fall from Stai
rs Dec/23/2020
UNK:UNK NO
End Date Time:
Dec/23/2020 UNK:
UNK
Repeating
Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932283
Page 44 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[traumatic brain injury]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932284
Page 45 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932285
Page 46 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021203036]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932286
Page 47 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Skull Fracture]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932287
Page 48 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932288
Page 49 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932289
Page 50 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Cervical Spine fracture]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932290
Page 51 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932291
Page 52 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932292
Page 53 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Rib Fractures]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/21/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932293
Page 54 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Fall]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932294
Page 55 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932295
Page 56 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fall from Stairs]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/23/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932296
Page 57 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932297
Page 58 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932298
Page 59 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932299
Page 60 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932300
Page 61 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932301
Page 62 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932302
Page 63 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932303
Page 64 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932304
Page 65 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932305
Page 66 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932306
Page 67 of 250
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932307
Page 68 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932308
Page 69 of 250
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932309
Page 70 of 250
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932310
Page 71 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932311
Page 72 of 250
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932312
Page 73 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932313
Page 74 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932314
Page 75 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932315
Page 76 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932316
Page 77 of 250
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/23/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932317
Page 78 of 250
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932318
Page 79 of 250
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932319
Page 80 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932320
Page 81 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932321
Page 82 of 250
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932322
Page 83 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932323
Page 84 of 250
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/25/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932324
Page 85 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [BPTN9V]
5.bSample ID [BS5H5Y]
5.cSample ID [BMPGTV]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932325
Page 86 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP52YB]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932326
Page 87 of 250
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 15:44
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
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932327
Page 88 of 250
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932328
Page 89 of 250
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932329
Page 90 of 250
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932330
Page 91 of 250
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932331
Page 92 of 250
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932332
Page 93 of 250
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932333
Page 94 of 250
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932334
Page 95 of 250
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932335
Page 96 of 250
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932336
Page 97 of 250
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932337
Page 98 of 250
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932338
Page 99 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/8/2020
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932339
Page 100 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932340
Page 101 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles
Harper Approved Mar-11-2021 23:48:15 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, 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.
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932341
Page 102 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-13-2020 14:42:00 (UTC-06:00)
Central Time (US & Canada)patient met all criteria and was
enrolled into the study
Not Applicable
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932342
Page 103 of 250
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormMar-03-2021 19:28:46 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932343
Page 104 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles
Harper Approved Mar-11-2021 23:48:15 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Mar-09-2021 11:10:40 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles
Harper Approved Mar-09-2021 00:04:59 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932344
Page 105 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Mar-04-2021 15:21:03 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles
Harper Approved Mar-03-2021 23:35:10 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Mar-01-2021 14:42:14 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932345
Page 106 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
N/A
Charles
Harper Approved Feb-28-2021 19:46:12 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Feb-25-2021 17:14:13 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles
Harper Approved Feb-24-2021 00:15:09 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932346
Page 107 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Feb-23-2021 13:41:54 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles
Harper Approved Nov-12-2020 07:44:39 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Nov-11-2020 19:55:51 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932347
Page 108 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
N/A
Charles
Harper Approved Oct-16-2020 15:13:45 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Oct-08-2020 10:05:57 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles
Harper Approved Sep-14-2020 20:31:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932348
Page 109 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, 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.
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932349
Page 110 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020
14:41:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020
14:41:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932350
Page 111 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020
14:41:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/13/2020Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932351
Page 112 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020
14:40:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11251020Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
14:40:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
14:41:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932352
Page 113 of 250
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14:41:28
(UTC-06:00)
Central Time (US
& Canada)NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020
14:41:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932353
Page 114 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020
14:41:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932354
Page 115 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020
14:42:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
14:42:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
14:42:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932355
Page 116 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020
14:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Hyperten
sion
Start Date: UNK/U
NK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020
14:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
14:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932356
Page 117 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.a Start Date:
Date Location User Value Reason
Aug-13-2020
14:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020
14:43:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-13-2020
14:44:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Anxiety
Start Date: UNK/U
NK/2018
Ongoing: YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932357
Page 118 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020
14:44:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
14:44:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020
14:44:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020
14:44:23
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932358
Page 119 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-13-2020
14:44:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Depressi
on
Start Date: UNK/U
NK/2000
Ongoing: YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932359
Page 120 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020
14:44:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
14:44:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020
14:44:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020
14:44:36
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932360
Page 121 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Aug-13-2020
14:45:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical Hi
story Term
:Caesarean
section
Start Date: UNK/UNK
/2007
Ongoing: NO
End Date:
UNK/U
NK/200
7Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932361
Page 122 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020
14:45:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
14:45:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Caesarean sectionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020
14:45:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020
14:45:31
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932362
Page 123 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada) UNK/UNK/2007
1.e
Date Location User Value Reason
Nov-11-2020
19:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:5
Medical
History T
erm:Nexplanon
placement
Start Dat
e:UNK/UN
K/2018
Ongoing: NO
End Date
:
UNK/
UNK/2
018Transcription
Error
Aug-13-2020
14:46:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:Implanon
placement
Start Dat
e:UNK/UN
K/2018Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932363
Page 124 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Dat
e:
UNK/
UNK/2
018
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932364
Page 125 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020
14:46:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-11-2020
19:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nexplanon placementTranscription
Error
Aug-13-2020
14:46:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Implanon placementInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020
14:46:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932365
Page 126 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-13-2020
14:46:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932366
Page 127 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
212.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932367
Page 128 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.2Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.3Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932368
Page 129 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932369
Page 130 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020
14:47:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932370
Page 131 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932371
Page 132 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932372
Page 133 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020
14:48:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932373
Page 134 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020
14:48:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
14:48:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
48757Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932374
Page 135 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
14:48:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
14:48:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
10:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
14:48:34
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932375
Page 136 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada) entered. Please
review and
correct as
appropriate.
Aug-13-2020
14:48:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
10:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP52KZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
10:07:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP52KZInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020
10:08:08ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932376
Page 137 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)Sample ID: BP52L0
5.b Sample ID
Date Location User Value Reason
Aug-14-2020
10:08:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP52L0Initial Entry
5.c
Date Location User Value Reason
Aug-14-2020
10:08:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP52L1Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020
10:08:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP52L1Initial Entry
5.d
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932377
Page 138 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-14-2020
15:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR88MInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020
15:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPR88MInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020
15:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR88NInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020
15:55:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPR88NInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932378
Page 139 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
14:48:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
14:48:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
14:48:48
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932379
Page 140 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada) entered. Please
review and
correct as
appropriate.
Aug-13-2020
14:48:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
17:40:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP52K
YTranscription
Error
Aug-14-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP5B6
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
17:40:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP52KYTranscription
Error
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932380
Page 141 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-14-2020
09:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5B6XInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932381
Page 142 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 ACV0PFEINFP6000 auto query Query 1: Closed Close Auto
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932382
Page 143 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
12:36:22
(UTC-06:00)
Central Time (US
& Canada)(autoquery) Query
Aug-14-2020
12:36:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020 12:17Transcription
Error
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date,
13/Aug/2020
21:17 is a
future date
relative to when
it was entered
on
13/Aug/2020
14:49. Please
correct.
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/13/2020 21:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932383
Page 144 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
6. Body Side:
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-13-2020
14:49:32
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932384
Page 145 of 250
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932385
Page 146 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-13-2020
14:49:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932386
Page 147 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020
19:00:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932387
Page 148 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
Sep-08-2020
19:03:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932388
Page 149 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
19:01:24
(UTC-06:00)
Central Time (US
& Canada)FEVER
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932389
Page 150 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932390
Page 151 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932391
Page 152 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.d Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932392
Page 153 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.e Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932393
Page 154 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932394
Page 155 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-08-2020
19:01:24ACV0PFEINFP6000 Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932395
Page 156 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932396
Page 157 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3. Injection Site Location:
Date Location User Value Reason
Sep-08-2020
19:03:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was complet
ed?:N
OInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932397
Page 158 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0932398
Page 159 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932399
Page 160 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Sep-08-2020
19:01:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932400
Page 161 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.1
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932401
Page 162 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020
19:01:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932402
Page 163 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932403
Page 164 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932404
Page 165 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020
19:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932405
Page 166 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020
19:02:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020
19:02:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
19:02:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
19:02:27
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932406
Page 167 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada) entered. Please
review and
correct as
appropriate.
Sep-08-2020
19:02:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
19:02:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BKMKX
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
19:02:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BKMKXTInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932407
Page 168 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932408
Page 169 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
19:03:28
(UTC-06:00)
Central Time (US
& Canada)Sep/4/2020 15:16
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932409
Page 170 of 250
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-08-2020
19:03:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932410
Page 171 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020
10:05:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932411
Page 172 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932412
Page 173 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10:07:24
(UTC-06:00)
Central Time (US
& Canada)FEVER
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932413
Page 174 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932414
Page 175 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932415
Page 176 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.d Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932416
Page 177 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.e Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932417
Page 178 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0932418
Page 179 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-08-2020
10:07:24ACV0PFEINFP6000 Data Entry:
Symptom:: NEWInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932419
Page 180 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932420
Page 181 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932421
Page 182 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932422
Page 183 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932423
Page 184 of 250
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data 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
Oct-08-2020
10:07:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932424
Page 185 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
10:07:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
10:07:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
12:50:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-09-2020
02:36:01
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932425
Page 186 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada) entered. Please
review and
correct as
appropriate.
Oct-08-2020
10:07:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
appropriate.
Oct-08-2020
10:07:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
12:50:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM5J0TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
12:50:19
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
BM5J0TInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932426
Page 187 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time (US
& Canada)
5.b
Date Location User Value Reason
Oct-09-2020
12:50:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM5J0VInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020
12:50:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BM5J0VInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
12:50:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR8P5Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932427
Page 188 of 250
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Oct-09-2020
12:50:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPR8P5Initial Entry
5.d
Date Location User Value Reason
Oct-09-2020
12:50:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7TPLInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-09-2020
12:50:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS7TPLInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932428
Page 189 of 250
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-08-2020
10:08:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020
10:08:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020
10:08:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932429
Page 190 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932430
Page 191 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932431
Page 192 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932432
Page 193 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932433
Page 194 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Mar-09-2021
11:14:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932434
Page 195 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021
10:04:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Cl
osedThank you. Clinical will
FU at a later date.
Mar-09-2021
17:00:07
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query 2: An
sweredwe have not received
records to update data at
this time
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0932435
Page 196 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada)
Mar-09-2021
03:45:18
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedPer PSSR comment
'Subject's gender is updated
to female in the Safety
Database- Discrepancy is
resolved'
Mar-08-2021
01:38:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Re
issued:Cand
idatefor PSSR review
Mar-04-2021
18:02:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Op
enedMedical Monitor_ Missing
details on symptoms of
onset, workup, treatment
on safety report. Pls
provide additional
information on hospital
course. Thanks
Mar-04-2021
14:24:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: An
sweredthe check box for female is
marked for this patient
Mar-01-2021
01:53:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#2021203036
,the gender was reported as
MALE in Safety database
but was recorded as
FEMALE in AE CRF.
Please confirm gender. If
safety update is required,
please submit a follow-up
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0932436
Page 197 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
form.
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
traumatic br
ain injuryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021
13:42:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-23-2021
13:42:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 UNK:U
NKTranscription
Error
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For traumatic
brain injury
Start Date
23/Dec/2021, is
a future date
relative to when
it was entered
on 23/Feb
/2021. Please
correct.
Feb-23-2021
13:41:54ACV0PFEINFP6000 Data Entry:
Dec/23/2021 UNK:UInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932437
Page 198 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)NK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021
11:10:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK
:UNKNew
Information
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932438
Page 199 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Feb-24-2021
05:21:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed
internally
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
traumatic
brain injury :
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bir
th defect?
NO
Did this serious even
t result in death?Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932439
Page 200 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
NO
Did this serious even
t require or prolong
hospitalization?
YES
Did this serious even
t result in persistent
or significant disabil
ity/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically imp
ortant 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.
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932440
Page 201 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021
12:35:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-09-2021
11:15:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Added AE for
fall from stairs
Mar-04-2021
18:06:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened If the traumatic
accident was a
fall, then fall
needs to be
reported
recorded as AEs
as well, even if
an injury did not
result. See
specific CRF
completion
guidelines
(8.50.2.2./falls).
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s), t
his event is due to:
OTHERInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0932441
Page 202 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
If Other, specify
:
fall
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932442
Page 203 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-12-2021
08:57:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedSAE RECON:AER#2021203036
,outcome was updated to
RECOVERED/RESOLVED on AE
CRF while reported as
Recovering/resolving in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Mar-09-2021
11:11:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Mar-09-2021
11:11:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RED/
RESO
LVE
DNew Information
Mar-09-2021
11:10:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedFor AE traumatic brain injury :
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932443
Page 204 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-02-2021
03:04:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Mar-01-2021
14:42:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Mar-01-2021
14:42:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGTranscription Error
Feb-25-2021
20:13:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2021203036,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-23-2021 ACV0PFEINFP6000 DataInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0932444
Page 205 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
13:41:54
(UTC-06:00)
Central Time
(US &
Canada)Entry
:
NOT
REC
OVE
RED/
NOT
RESO
LVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021
13:41:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-25-2021
20:07:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021203036Initial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932445
Page 206 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Skull FractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932446
Page 207 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021
11:11:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:
UNKNew
Information
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932447
Page 208 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-09-2021
12:36:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-09-2021
11:15:15ACV0PFEINFP6000 Query 1: Answered Added AE for
fall from stairs
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932448
Page 209 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time (US
& Canada)
Mar-05-2021
11:18:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls
enter separate
AE term for
'fall' as per
CRF
guidelines.
Thanks
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), thi
s event is due to:
OTHER
If Other, specify:
fallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932449
Page 210 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
11:12:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-09-2021
11:12:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/
RESOLVEDNew Information
Mar-09-2021
11:11:51
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opene
dFor AE Skull Fracture:
Response to "What
was the outcome of
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932450
Page 211 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Central Time
(US & Canada)this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/
RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021
08:45:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932451
Page 212 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Cervical Spine fractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932452
Page 213 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932453
Page 214 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
FallInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932454
Page 215 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932455
Page 216 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021
08:47:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932456
Page 217 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Rib FracturesInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932457
Page 218 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/23/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/21/2021 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932458
Page 219 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
FallInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932459
Page 220 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932460
Page 221 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021
08:55:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d20\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932461
Page 222 of 250
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021
11:14:14
(UTC-06:00)
Central Time (
…[truncated]