Document text
Page 1 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932886
Page 2 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec/8/2020
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932887
Page 3 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11251243]
2.Birth Date: 2003
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932888
Page 4 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932889
Page 5 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932890
Page 6 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathDec/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932891
Page 7 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:[Seasonal allergies]
Start Date: UNK/UNK/2004
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932892
Page 8 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932893
Page 9 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Dec/8/2020
2.Weight: [132.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [22.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932894
Page 10 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/8/2020
2.Randomization Number: [112420]
3.Randomization Group: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932895
Page 11 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
Dec/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7CHW]
5.bSample ID [BR7CHX]
5.cSample ID [BMPGMT]
5.dSample ID [BS5H14]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932896
Page 12 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
Dec/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTN04]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932897
Page 13 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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: Dec/8/2020 18:03
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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932898
Page 14 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932899
Page 15 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932900
Page 16 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932901
Page 17 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932902
Page 18 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Dec/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932903
Page 19 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
Dec/30/2020
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 [BPTN0Y]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932904
Page 20 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932905
Page 21 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932906
Page 22 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
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?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932907
Page 23 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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?Not Done Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932908
Page 24 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
Jan/29/2021
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 [BPTN6T]
5.bSample ID [BPTN6V]
5.cSample ID [BMPGRC]
5.dSample ID [BS5H3K]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932909
Page 25 of 202
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932910
Page 26 of 202
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932911
Page 27 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932912
Page 28 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932913
Page 29 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932914
Page 30 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932915
Page 31 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932916
Page 32 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932917
Page 33 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932918
Page 34 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932919
Page 35 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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?
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932920
Page 36 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932921
Page 37 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932922
Page 38 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932923
Page 39 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932924
Page 40 of 202
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932925
Page 41 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Grade 3 Pain at Inject
ion site Dec/9/2020 UNK
:UNK NO
End Date Time:
Dec/9/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Grade 3 Headache Dec/9/2020 UNK
:UNK NO
End Date Time:
Dec/9/2020 UNK:UNK
Repeating
Pages
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932926
Page 42 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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)[Grade 3 Pain at Injection site]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932927
Page 43 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932928
Page 44 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Grade 3 Headache]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932929
Page 45 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932930
Page 46 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932931
Page 47 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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[ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932932
Page 48 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932933
Page 49 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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: //
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932934
Page 50 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932935
Page 51 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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?
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932936
Page 52 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932937
Page 53 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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?
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932938
Page 54 of 202
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932939
Page 55 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932940
Page 56 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932941
Page 57 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932942
Page 58 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
Dec/10/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932943
Page 59 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Dec/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932944
Page 60 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Dec/10/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932945
Page 61 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.cSymptom: HEADACHE
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: YES
Symptom Grade:
1
Event related to Study Treament?
YES
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: YES
Symptom Grade:
1
Event related to Study Treament?
YES
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932946
Page 62 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932947
Page 63 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932948
Page 64 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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?
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932949
Page 65 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932950
Page 66 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932951
Page 67 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932952
Page 68 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932953
Page 69 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932954
Page 70 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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 [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932955
Page 71 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/9/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932956
Page 72 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932957
Page 73 of 202
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932958
Page 74 of 202
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932959
Page 75 of 202
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932960
Page 76 of 202
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932961
Page 77 of 202
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932962
Page 78 of 202
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/9/2020
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932963
Page 79 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932964
Page 80 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles Harper Approved Feb-24-2021 00:30:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932965
Page 81 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormDec-09-2020 08:44:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932966
Page 82 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
FormFeb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
FormDec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932967
Page 83 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
1Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
1Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932968
Page 84 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
2Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
2Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932969
Page 85 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada) )Not Done
3Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
3Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada) )Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932970
Page 86 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
4Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
4Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932971
Page 87 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
5Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
5Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932972
Page 88 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
6Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
6Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932973
Page 89 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
7Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
7Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932974
Page 90 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
8Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
8Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932975
Page 91 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
9Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
9Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932976
Page 92 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
10Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
10Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
10Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932977
Page 93 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
11Feb-22-2021 18:09:52 (UTC-06:00) Central
Time (US & Canada)Not Done
11Feb-22-2021 18:08:11 (UTC-06:00) Central
Time (US & Canada)
11Dec-30-2020 15:03:13 (UTC-06:00) Central
Time (US & Canada)Second vaccination withheld due to subject
having severe reactions to first vaccination
Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932978
Page 94 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932979
Page 95 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Feb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932980
Page 96 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.aFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932981
Page 97 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.bFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932982
Page 98 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.cFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932983
Page 99 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.dFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932984
Page 100 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.eFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932985
Page 101 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2 fFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932986
Page 102 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2.gFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932987
Page 103 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2 hFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932988
Page 104 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Feb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932989
Page 105 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Feb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932990
Page 106 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932991
Page 107 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932992
Page 108 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cFeb-22-2021 08:24:28 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0932993
Page 109 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Charles Harper Approved Feb-24-2021 00:30:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-17-2021 15:36:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Feb-09-2021 22:52:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-29-2021 15:42:14 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932994
Page 110 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Charles Harper Approved Jan-09-2021 11:28:32 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-31-2020 09:48:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Dec-30-2020 23:18:43 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-30-2020 14:59:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Charles Harper Approved Dec-14-2020 22:48:40 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932995
Page 111 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, CharlesHarper, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0932996
Page 112 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec-09-2020 08:43:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Dec-09-2020 08:43:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932997
Page 113 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-09-2020 08:44:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/8/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932998
Page 114 of 202
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-09-2020 08:42:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11251243Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Dec-09-2020 08:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2003Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-09-2020 08:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-09-2020 08:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-09-2020 08:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0932999
Page 115 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-09-2020 08:44:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933000
Page 116 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec-09-2020 08:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-09-2020 08:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-09-2020 08:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933001
Page 117 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Dec-09-2020 08:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Seasonal aller
gies
Start Date: UNK/UNK/2
004
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-09-2020 08:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-09-2020 08:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Dec-09-2020 08:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-09-2020 08:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933002
Page 118 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b
Date Location User Value Reason
Dec-09-2020 08:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Tonsillitis
Start Date: UNK/UNK/20
05
Ongoing: NO
End Date:
UNK/UNK/
2005Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933003
Page 119 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Dec-09-2020 08:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-09-2020 08:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TonsillitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Dec-09-2020 08:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-09-2020 08:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.c
Date Location User Value Reason
Dec-09-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Tonsillectomy
Start Date: UNK/UNK/20
05Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933004
Page 120 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: NO
End Date:
UNK/UNK/
2005
1.c Line/MH Number:
Date Location User Value Reason
Dec-09-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-09-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TonsillectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-09-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Dec-09-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933005
Page 121 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Dec-09-2020 08:47:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933006
Page 122 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
132.0Initial Entry
3. Unit:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.0Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933007
Page 123 of 202
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
7.a
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Dec-09-2020 08:51:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933008
Page 124 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-09-2020 08:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-09-2020 08:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
112420Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933009
Page 125 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 08:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 08:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020 17:04:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 08:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-09-2020 08:52:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020 17:04:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7CHWInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933010
Page 126 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Dec-09-2020 17:04:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR7CHWInitial Entry
5.b
Date Location User Value Reason
Dec-09-2020 17:05:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7CHXInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-09-2020 17:05:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR7CHXInitial Entry
5.c
Date Location User Value Reason
Dec-09-2020 17:05:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMPGMTInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-09-2020 17:05:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMPGMTInitial Entry
5.d
Date Location User Value Reason
Dec-09-2020 17:05:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS5H14Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933011
Page 127 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d Sample ID
Date Location User Value Reason
Dec-09-2020 17:05:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS5H14Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933012
Page 128 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 08:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 08:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020 17:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 08:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-09-2020 08:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020 17:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTN04Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933013
Page 129 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Sample ID
Date Location User Value Reason
Dec-09-2020 17:04:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTN04Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933014
Page 130 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-14-2020
00:52:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedUnplanned visit
added
Dec-11-2020
16:57:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
deCRF added
Dec-11-2020
00:09:24
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPDQ: Subject
has reported
with Severe
symptoms
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933015
Page 131 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US &
Canada)reactions on
2020 12 09 .
Per protocol,
subjects
experiencing
Grade 3 local
reactions
should be
contacted.
Please confirm
if an
UNPLANNED
CONTACT
was made and
update the
corresponding
form as
appropriate.
Dec-09-2020
08:53:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
Dec/8/20
20 18:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933016
Page 132 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-09-2020 08:53:31
(UTC-06:00) Central
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
Dec-09-2020 08:53:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933017
Page 133 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec-09-2020 08:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933018
Page 134 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-30-2020 14:59:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933019
Page 135 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
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
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933020
Page 136 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933021
Page 137 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.c Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933022
Page 138 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933023
Page 139 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.f Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933024
Page 140 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933025
Page 141 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933026
Page 142 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-30-2020 15:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933027
Page 143 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020Initial Entry
2.a
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.4
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933028
Page 144 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.a Temperature Location:
Date Location User Value Reason
Dec-30-2020 15:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933029
Page 145 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-30-2020 15:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-30-2020 15:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-31-2020 09:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-30-2020 23:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-30-2020 15:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-30-2020 15:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/30/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933030
Page 146 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Dec-31-2020 09:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTN0YInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-31-2020 09:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTN0YInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933031
Page 147 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Feb-23-2021 10:28:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Feb-22-2021 18:10:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Feb-05-2021 14:37:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Opened CLINQUERY: If
second dose will not
be given (not just
delayed), please
capture events in
AE listing since
related to end of
treatment. EOT
page then also needs
updating to match
date and reason for
Rx discontinuation
Feb-05-2021 09:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Second dose was
withheld due to
subject reporting
severe side effects
to first vaccine,
including headache
and injection site
pain.
Feb-05-2021 06:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY:
Please clarify why
second dose of
study vax was not
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933032
Page 148 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
given. There is no
AE or other data in
CRF. EOT status
should match to the
reason why
treatment was
discontinued.
Jan-04-2021 02:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
response.
Dec-31-2020 09:49:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per PI patient to not
receive 2nd vaccine
Dec-31-2020 04:19:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please confirm
if Comment entered
needs to be recorded
in appropriate data
point. Please
confirm and correct
else clarify, thank
you.
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933033
Page 149 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933034
Page 150 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933035
Page 151 of 202
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-22-2021 18:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 18:08:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-30-2020 15:03:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933036
Page 152 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021 04:05:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-01-2021 09:32:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-01-2021 03:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete EOT
visit. Thank you.
Jan-29-2021 15:42:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933037
Page 153 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Feb-23-2021 01:30:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Data updated by
site.
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:21:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-22-2021 08:21:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-09-2021 06:53:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary: Vaccination
2 is ‘Not Done’ and
eDiary data not
available however
corresponding
‘Symptom Resolved
CRF’ in visit 3 is
entered with data.
Kindly verify and
consider updating
form level comment
as Not Applicable.
Thanks!
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FEInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933038
Page 154 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Do
ne
Feb-22-2021 08:21:50
(UTC-06:00) Central
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?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:21:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0933039
Page 155 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Do
neInitial Entry
Feb-22-2021 08:22:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933040
Page 156 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.b Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:22:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
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?:Not
Don
eInitial Entry
Feb-22-2021 08:22:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HETranscription Error
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933041
Page 157 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
2.c Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:22:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILLInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0933042
Page 158 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
S
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Do
ne
Feb-22-2021 08:22:55
(UTC-06:00) Central
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?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933043
Page 159 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.d Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:22:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
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?:Not
Don
eInitial Entry
Feb-22-2021 08:23:06
(UTC-06:00) Central
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?:Transcription Error
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0933044
Page 160 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:23:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
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?:Not
Don
eInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933045
Page 161 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 08:23:15
(UTC-06:00) Central
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?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
2.f Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:23:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933046
Page 162 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
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?:Not DoneInitial Entry
Feb-22-2021 08:23:26
(UTC-06:00) Central
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?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933047
Page 163 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.g Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:23:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:Not DoneInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933048
Page 164 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
2.h
Date Location User Value Reason
Feb-22-2021 08:23:38
(UTC-06:00) Central
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?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933049
Page 165 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
2.h Symptom:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:23:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:21:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933050
Page 166 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 08:23:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Not
Don
eInitial Entry
Feb-22-2021 08:23:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0933051
Page 167 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:23:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:Not
Don
eInitial Entry
Feb-22-2021 08:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
INGInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0933052
Page 168 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
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
Diary was completed
?:Not Do
neInitial Entry
Feb-22-2021 08:24:18
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0933053
Page 169 of 202
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject
Diary was completed
?:
Jan-29-2021 15:45:32
(UTC-06:00) Central
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
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-22-2021 08:24:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-22-2021 08:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-29-2021 15:45:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933054
Page 170 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 15:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 15:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-31-2021 21:09:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-29-2021 15:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-29-2021 15:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0933055
Page 171 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Feb-01-2021 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTN6TInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-01-2021 15:00:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTN6TInitial Entry
5.b
Date Location User Value Reason
Feb-01-2021 15:00:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTN6VInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-01-2021 15:00:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTN6VInitial Entry
5.c
Date Location User Value Reason
Feb-01-2021 15:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMPGRCInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-01-2021 15:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMPGRCInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933056
Page 172 of 202
***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, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d
Date Location User Value Reason
Feb-01-2021 15:00:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS5H3KInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-01-2021 15:00:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS5H3KInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933057
Page 173 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933058
Page 174 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933059
Page 175 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Grade 3 Pain at Injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933060
Page 176 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933061
Page 177 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 17:42:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933062
Page 178 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Grade 3 HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933063
Page 179 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933064
Page 180 of 202
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-22-2021 17:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933065
Page 181 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-11-2020 16:17:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020Transcription Error
Dec-11-2020 16:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/11/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933066
Page 182 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Assessments
Date Location User Value Reason
Dec-11-2020 16:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-11-2020 16:17:21
(UTC-06:00) Central
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.
Dec-11-2020 16:17:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933067
Page 183 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Contact Type:
Date Location User Value Reason
Dec-11-2020 16:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Dec-11-2020 16:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-11-2020 16:17:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-11-2020 16:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but
no 'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL
REACTION' form(s)
is/are entered. Please
review and update as
appropriate.
Dec-11-2020 16:17:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Contact
10/Dec/2020 is not
equal to the Date of
Visit 11/Dec/2020
within same
unplanned visit.
Please review and
update as
appropriate.
Dec-11-2020 16:17:40 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0933068
Page 184 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00) Central
Time (US & Canada)YES
Date of Contact:
Dec/10/2020
Contact Outcome:
VISIT ARRANGED
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0933069
Page 185 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020Initial Entry
2.a
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.0
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0933070
Page 186 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Dec-11-2020 16:18:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933071
Page 187 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-11-2020 16:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/10/2020Initial Entry
2. Injection Site Location
Date Location User Value Reason
Dec-11-2020 16:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Dec-11-2020 16:31:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
4.a
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: REDNESS
Reaction Present:: NOInitial Entry
4.a Reaction:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933072
Page 188 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Reaction:: SWELLING
Reaction Present:: NOInitial Entry
4.b Reaction:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:PAIN AT INJECTIO
N SITE
Symptom
Present::YES
Symptom Grade:
3
Event related to St
udy Treament?
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933073
Page 189 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Symptom Grade:
3
Event related to Study Treament
?
YESInitial Entry
5.b
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:FATIGUE/TIREDN
ESS
Symptom
Present::YES
Symptom Grade:
3
Event related to St
udy Treament?
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933074
Page 190 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Symptom Grade:
3
Event related to Study Treament
?
YESInitial Entry
5.c
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:HEADACHE
Symptom
Present::YES
Symptom Grade:
3
Event related to St
udy Treament?
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933075
Page 191 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Symptom Grade:
3
Event related to Study Treament
?
YESInitial Entry
5.d
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VOMITIN
G
Symptom Present:
:NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933076
Page 192 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.e
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIARRHE
A
Symptom Present:
:NOInitial Entry
5.e Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933077
Page 193 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
::NEW OR WORSEN
ED MUSCLE PAIN
Symptom
Present::YES
Symptom Grade:
1
Event related to Stu
dy Treament?
YESInitial Entry
5.f Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Symptom Grade:
1
Event related to Study Treament
?
YESInitial Entry
5.g
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:NEW OR WORSE
NED JOINT PAIN
Symptom
Present::NOInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933078
Page 194 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.g Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.h
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:
:CHILLS
Symptom
Present::YES
Symptom Grade:
1
Event related to St
udy Treament?
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933079
Page 195 of 202
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/10/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.h Symptom:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Dec-11-2020 16:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Symptom Grade:
1
Event related to Study Treament
?
YESInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933080
Page 196 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 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
Feb-22-2021 18:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 18:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2020Transcription Error
Feb-22-2021 18:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date of
Completion/Discontinuation
/Death" 09/Dec/2021 is a
future date relative to when
it was entered on 22/Feb
/2021. Please correct.
Feb-22-2021 18:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2021Transcription Error
Feb-22-2021 18:08:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date of
Completion/Discontinuation
/Death" 29/Dec/2021 is a
future date relative to when
it was entered on 22/Feb
/2021. Please correct.
Feb-22-2021 18:08:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/29/2021New Information
Feb-01-2021 09:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-01-2021 09:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933081
Page 197 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3. Status:
Date Location User ValueReason
Feb-23-2021
11:00:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
3: Clo
sedResponse satisfies
query
Feb-23-2021
10:09:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: An
swere
dPer query
Feb-23-2021
10:09:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ADV
ERSE
EVE
NTPer query
Feb-23-2021
05:29:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
3: Op
enedCLINQUERY: AEs
are listed reporting
DRUG
WITHDRAWN in
response to the
events. If correct,
please amend status
selection on this end
of treatment page to
be ADVERSE
EVENT to match to
the AE entries
Feb-22-2021
18:09:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Feb-22-2021
18:09:29ACV0PFEINFP6000 Data
EntryNew Information
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933082
Page 198 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-06:00)
Central Time
(US &
Canada):
PHYS
ICIA
N DE
CISIO
N
Feb-17-2021
20:53:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_23
Feb-17-2021
15:36:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
enedResponse to "Status"
is OTHER but
"Specify Status" is
missing.
Feb-17-2021
15:36:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-17-2021
15:36:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
OTH
ERTranscription Error
Feb-03-2021
03:00:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dPlease update Status
as per your response
'subject had second
vaccination
withheld'. Kindly
reach out to CRA if
assistance is
required.
Feb-02-2021
17:36:13
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query
1: An
swere
dsubject had second
vaccination withheld
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933083
Page 199 of 202
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US &
Canada)
Feb-02-2021
05:15:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7086116;Status
on the Disposition -
Treatment form is
COMPLETED but at
least one Dose Date
is missing. Please
review and update as
appropriate.
Feb-01-2021
09:32:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
COM
PLET
EDInitial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933084
Page 200 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-23-2021 10:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDPer query
Feb-22-2021 18:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDNew Information
Feb-17-2021 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Feb-01-2021 09:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Dec-09-2020 08:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Dec-09-2020 08:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-23-2021 10:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2020Per query
Feb-22-2021 18:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2020New Information
Feb-22-2021 18:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2020Transcription Error
Feb-22-2021 18:09:00
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/9/2021Transcription Error
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933085
Page 201 of 202
***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: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
Feb-22-2021 18:08:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/29/2021New Information
Feb-17-2021 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/29/2021Transcription Error
Feb-01-2021 09:32:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/29/2021Initial Entry
Dec-09-2020 08:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/8/2020Initial Entry
Dec-09-2020 08:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/8/2020Initial Entry
090177e196ae3d1f\Final\Final On: 01-Apr-2021 04:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933086
Page 202 of 202
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1125 Site Name: (1125) Meridian Clinical Research
Subject No: 11251243 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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1. Casebook Signature
Date Location User Value Reason
Dec-10-2020 17:29:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
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09017
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