Document text
Page 1 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798691
Page 2 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/5/2020
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798692
Page 3 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11201059]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798693
Page 4 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/5/2020
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798694
Page 5 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798695
Page 6 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798696
Page 7 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:[post traumatic stress disorder]
Start Date: UNK/UNK/2001
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/1994
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[endometriosis]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1994
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/1997
Ongoing: YES
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798697
Page 8 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2014
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataract]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798698
Page 9 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [74.9]
3.Unit: kg
4.Height: [158.0]
5.Unit: cm
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798699
Page 10 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798700
Page 11 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222719]
3.Randomization Group: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798701
Page 12 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/5/2020
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 [BP5R8X]
5.bSample ID [BP5R8Y]
5.cSample ID [BP5R8Z]
5.dSample ID [BPR2Y6]
5.eSample ID [BPR2Y7]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798702
Page 13 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/5/2020
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 [BP5R8P]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798703
Page 14 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/5/2020 13:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798704
Page 15 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798705
Page 16 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798706
Page 17 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798707
Page 18 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798708
Page 19 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798709
Page 20 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/26/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE Comments
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798710
Page 21 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/26/2020
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 [BP8VJ3]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798711
Page 22 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/26/2020 11:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798712
Page 23 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798713
Page 24 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798714
Page 25 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798715
Page 26 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/2/2020
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 [BMN7YY]
5.bSample ID [BMN7YZ]
5.cSample ID [BP8WMT]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798716
Page 27 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798717
Page 28 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/17/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHVSVL]
5.bSample ID [BHDKJK]
5.cSample ID [BHDKJL]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798718
Page 29 of 165
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798719
Page 30 of 165
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798720
Page 31 of 165
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798721
Page 32 of 165
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798722
Page 33 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798723
Page 34 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798724
Page 35 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798725
Page 36 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798726
Page 37 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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?
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798727
Page 38 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798728
Page 39 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798729
Page 40 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798730
Page 41 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798731
Page 42 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798732
Page 43 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/31/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798733
Page 44 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798734
Page 45 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798735
Page 46 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798736
Page 47 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798737
Page 48 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 breast cancer
Nov/5/2020 UNK:U
NK NO
End Date Time:
Dec/2/2020 UNK:UNK
Repeating
Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798738
Page 49 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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)[breast cancer]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798739
Page 50 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021201046]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798740
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798741
Page 52 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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[ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798742
Page 53 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798743
Page 54 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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: //
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798744
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798745
Page 56 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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?
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798746
Page 57 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798747
Page 58 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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?
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798748
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798749
Page 60 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798750
Page 61 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798751
Page 62 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798752
Page 63 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798753
Page 64 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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?
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798754
Page 65 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798755
Page 66 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798756
Page 67 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798757
Page 68 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798758
Page 69 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798759
Page 70 of 165
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 [ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798760
Page 71 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798761
Page 72 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798762
Page 73 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798763
Page 74 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Done
//Comments
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798764
Page 75 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Done
//Comments
Cause of Death
2.Cause of Death Status: Not Done
Cause of Death: Not Done
[ ]
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798765
Page 76 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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/2/2020
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798766
Page 77 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798767
Page 78 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798768
Page 79 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-06-2020 15:15:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798769
Page 80 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6.aAug-26-2020 13:58:18 (UTC-05:00) Eastern
Time (US & Canada)Test was not done
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798770
Page 81 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-28-2021 11:03:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798771
Page 82 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-28-2021 11:03:41 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798772
Page 83 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-28-2021 11:03:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798773
Page 84 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Jan-28-2021 11:03:54 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798774
Page 85 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-28-2021 11:03:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Bradley Approved Oct-12-2020 12:19:30 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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 Sep-29-2020 14:25:55 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Bradley Approved Sep-17-2020 15:33:57 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulBradley, 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.
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798775
Page 86 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-06-2020 15:14:58
(UTC-05:00) Eastern
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-06-2020 15:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798776
Page 87 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-06-2020 15:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798777
Page 88 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-06-2020 15:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11201059Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-06-2020 15:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-06-2020 15:15:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-06-2020 15:15:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020 10:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798778
Page 89 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-06-2020 15:15:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798779
Page 90 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-06-2020 15:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-06-2020 15:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-06-2020 15:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798780
Page 91 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020 15:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:post traumatic str
ess disorder
Start Date: UNK/UNK/2001
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:16:22
(UTC-05:00) Eastern
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-06-2020 15:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
post traumatic stress disorderInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-06-2020 15:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-06-2020 15:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798781
Page 92 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b
Date Location User Value Reason
Aug-06-2020 15:16:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:hysterectomy
Start Date: UNK/UNK/199
4
Ongoing: NO
End Date:
UNK/UNK/
1994Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798782
Page 93 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:16:37
(UTC-05:00) Eastern
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-06-2020 15:16:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020 15:16:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020 15:16:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.c
Date Location User Value Reason
Aug-06-2020 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:endometriosis
Start Date: UNK/UNK/199
1Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798783
Page 94 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date:
UNK/UNK/
1994
1.c Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:16:55
(UTC-05:00) Eastern
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-06-2020 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
endometriosisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-06-2020 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1991Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-06-2020 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.d
Date Location User Value Reason
Aug-06-2020 15:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798784
Page 95 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical Hist
ory Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/1997
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:17:06
(UTC-05:00) Eastern
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-06-2020 15:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gastroesophageal Reflux DiseaseInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-06-2020 15:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-06-2020 15:17:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-06-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:hypothyroidis
mInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798785
Page 96 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Start Date: UNK/UNK/2
014
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:17:23
(UTC-05:00) Eastern
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
Aug-06-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-06-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-06-2020 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-06-2020 15:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:cataract
Start Date: UNK/UNK/2
015Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798786
Page 97 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-06-2020 15:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 15:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cataractInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-06-2020 15:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-06-2020 15:17:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798787
Page 98 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
74.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
158.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798788
Page 99 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.9
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-06-2020 15:17:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798789
Page 100 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798790
Page 101 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-06-2020 15:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798791
Page 102 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-06-2020 15:18:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-06-2020 15:18:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
222719Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798792
Page 103 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 09:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 09:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User ValueReason
Aug-12-2020
15:06:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_04
Aug-12-2020
11:18:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dChanged Information
Aug-12-2020
11:18:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YES
Date
of C
ollec
tion:
AuChanged Information
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798793
Page 104 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
g/5
/20
20
Aug-11-2020
05:56:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Op
enedDMW4171035;Date
of Collection is
earlier or more than 1
day after Date of
Visit. Please clarify
or correct.
Aug-07-2020
09:14:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Del
etedClose Auto Query
Aug-07-2020
09:14:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ca
ndidat
e'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-07-2020
09:14:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YES
Date
of C
ollec
tion:
Jul
/5/
20
20Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020 09:14:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5R8XInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798794
Page 105 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 09:14:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5R8XInitial Entry
5.b
Date Location User Value Reason
Aug-07-2020 09:14:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5R8YInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-07-2020 09:14:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5R8YInitial Entry
5.c
Date Location User Value Reason
Aug-07-2020 09:14:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5R8ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-07-2020 09:14:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5R8ZInitial Entry
5.d
Date Location User Value Reason
Aug-07-2020 09:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR2Y6Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798795
Page 106 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d Sample ID
Date Location User Value Reason
Aug-07-2020 09:15:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR2Y6Initial Entry
5.e
Date Location User Value Reason
Aug-07-2020 09:15:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPR2Y7Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-07-2020 09:15:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPR2Y7Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798796
Page 107 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020 09:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020 09:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020 09:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-07-2020 09:13:29
(UTC-05:00) Eastern
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.
Aug-07-2020 09:13:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/5/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020 09:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5R8PInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798797
Page 108 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Aug-07-2020 09:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5R8PInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798798
Page 109 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/5/2020 13:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798799
Page 110 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-06-2020 15:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798800
Page 111 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-06-2020 15:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798801
Page 112 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-26-2020 13:54:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798802
Page 113 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798803
Page 114 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798804
Page 115 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798805
Page 116 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798806
Page 117 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798807
Page 118 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED 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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798808
Page 119 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798809
Page 120 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
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
Aug-26-2020 13:55:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798810
Page 121 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2.a
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 37.0
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798811
Page 122 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 13:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798812
Page 123 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798813
Page 124 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-26-2020 14:11:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEChanged
Information
Aug-26-2020 13:56:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done:: NOT DONEInitial Entry
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 13:56:01
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798814
Page 125 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) 3
6.a Result:
Date Location User Value Reason
Aug-26-2020 14:11:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Aug-26-2020 13:56:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-26-2020 14:11:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 13:56:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Not Done is
indicated however
result is provided.
Please correct or
clarify.
Aug-26-2020 13:56:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798815
Page 126 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 13:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 13:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 18:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Aug-27-2020 18:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 18:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-27-2020 18:06:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/26/2020Changed
Information
Aug-27-2020 18:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No
and 'If no sample
was collected or
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798816
Page 127 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
sample was not
collected according
to protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Aug-27-2020 18:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 13:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?'
is marked as No
and 'If no sample
was collected or
sample was not
collected according
to protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Aug-26-2020 13:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-27-2020 18:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Aug-27-2020 18:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
self swab was collectedInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020 18:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8VJ3Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798817
Page 128 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 18:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8VJ3Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798818
Page 129 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 07:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed unpl updated
Sep-04-2020 14:35:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Sep-02-2020 01:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened PDQ: RQ1: Thank
you for response
Contact was made
documented in
source. Per section
8.43 of CRF
Completion
Requirements, please
consider updating
"Was contact made?"
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798819
Page 130 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
as 'Yes' and select
appropriate Contact
Outcome option
present on
UNPLANNED
VISIT (UNPL).
Sep-01-2020 08:27:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Contact was made
documented in
source
Sep-01-2020 07:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Subject has
reported severe
symptoms/reaction in
eDiary data on
30Aug2020. Please
confirm if an
UNPLANNED
contact was made
and update the data
as appropriate.
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020 11:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798820
Page 131 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 18:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798821
Page 132 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-07-2020 08:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-07-2020 07:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Oct-06-2020 09:05:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Date is correct
Oct-06-2020 09:04:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-06-2020 07:17:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (2 day) from
DOV (26/Aug/2020)
at V2_VAX2_L.
Please reconcile and
update accordingly,
else confirm date is
correct as is.
Oct-06-2020 04:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete
‘Immunogenicity
form' at this visit.
Thank you.
Oct-02-2020 15:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798822
Page 133 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798823
Page 134 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798824
Page 135 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798825
Page 136 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798826
Page 137 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED 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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798827
Page 138 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798828
Page 139 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798829
Page 140 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:29:37
(UTC-05:00) Eastern
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-02-2020 15:29:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798830
Page 141 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 09:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 09:02:52
(UTC-05:00) Eastern
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-06-2020 09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 09:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMN7YYInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798831
Page 142 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 09:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMN7YYInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 09:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMN7YZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 09:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMN7YZInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 09:03:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8WMTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 09:03:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8WMTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798832
Page 143 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 09:40:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798833
Page 144 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 09:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 09:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 09:41:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 09:40:57
(UTC-05:00) Eastern
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.
Mar-09-2021 09:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Mar-09-2021 09:41:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHVSVLInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798834
Page 145 of 165
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Mar-09-2021 09:41:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BHVSVLInitial Entry
5.b
Date Location User Value Reason
Mar-09-2021 09:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHDKJKInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-09-2021 09:41:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BHDKJKInitial Entry
5.c
Date Location User Value Reason
Mar-09-2021 09:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BHDKJLInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-09-2021 09:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BHDKJLInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798835
Page 146 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-04-2020 14:33:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798836
Page 147 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Assessments
Date Location User Value Reason
Sep-04-2020 14:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form
is not entered.
Please review and
update as
appropriate.
Sep-04-2020 14:33:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798837
Page 148 of 165
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/31/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-04-2020 14:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-04-2020 14:35:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Aug/31/2020
Contact Outcome:
VISIT NOT ARRANGED, R
EACTION NO LONGER PR
ESENTInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798838
Page 149 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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-09-2020 16:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-09-2020 12:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-09-2020 12:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
Oct-09-2020 07:28:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please
review and update
missing date of
EOT (as per below
query) and Phase of
Disposition since
visit 3 is complete.
Thanks
Oct-08-2020 10:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-08-2020 10:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-07-2020 15:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
update date of EOT
to match the date
the Visit 3(1 month)
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798839
Page 150 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
visit was
completed.
Sep-29-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 12:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
Oct-08-2020 10:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed
Information
Sep-29-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-29-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798840
Page 151 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798841
Page 152 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
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-08-2021 18:06:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Mar-05-2021 17:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Lump found in
breast during routine
exam
Mar-04-2021 17:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened Medical Monitor_
Pls advise
symptoms of onset
that prompted the
diagnosis. Thanks
Feb-26-2021 19:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-26-2021 16:39:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered THIS WAS
REPORTED FOR
SAE AND
RECORDS HAVE
BEEN
REQUESTED
Feb-22-2021 08:40:50 ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0798842
Page 153 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)what stage the
breast cancer is,
review seriousness
criteria and confirm
this is not an
SAE/IME or notify
sponsor
immediately.
Thanks
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
breast cancerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 17:23:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/5/2020 UNK:UNKNew Information
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 16:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKNew Information
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798843
Page 154 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 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).
Date Location User Value Reason
Mar-01-2021 05:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-01-2021 05:00:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-26-2021 16:37:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE breast cancer:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-26-2021 16:37:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-26-2021 16:37:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event resultNew Information
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798844
Page 155 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
YES
Other medically important
serious event
NO
Feb-26-2021 04:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021201046
breast cancer(onset date:--
Nov2020)was reported as
serious in Safety database
but nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
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
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798845
Page 156 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-26-2021 19:03:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-26-2021 16:41:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered MEDICATIONS
WERE GIVEN
AND ADDED IN
SAE
Feb-22-2021 08:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
what medication
given. Thanks
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-26-2021 16:38:41
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798846
Page 157 of 165
***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: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
Feb-26-2021 16:38:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-26-2021 16:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE breast
cancer: Response to
"What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-19-2021 08:31:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-01-2021 05:00:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021201046Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798847
Page 158 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 11:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798848
Page 159 of 165
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-28-2021 11:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 11:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-28-2021 11:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798849
Page 160 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-28-2021 11:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-28-2021 11:03:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798850
Page 161 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-28-2021 11:03:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798851
Page 162 of 165
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-28-2021 11:03:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798852
Page 163 of 165
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-10-2021 04:27:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-09-2021 12:44:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Mar-09-2021 03:03:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Visit 4 is
overdue based on
expected visit
window. Please
enter data or, if
visit will never
occur, mark Date
of Visit as ‘Not
Done’ with form
level comment. If
subject is no longer
in the trial,
complete the
Disposition FUP
form.
Sep-29-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-06-2020 15:18:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-06-2020 15:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 12:51:56
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798853
Page 164 of 165
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
Oct-08-2020 10:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/5/2020Changed
Information
Sep-29-2020 14:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
Aug-06-2020 15:18:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
Aug-06-2020 15:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/5/2020Initial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798854
Page 165 of 165
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1120 Site Name: (1120) Meridian Clinical Research
Subject No: 11201059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-16-2020 09:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae4000\Final\Final On: 01-Apr-2021 05:27 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798855