Document text
Page 1 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911095
Page 2 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911096
Page 3 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10461175]
2.Birth Date: 1988
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911097
Page 4 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911098
Page 5 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911099
Page 6 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911100
Page 7 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ADHD]
Start Date: UNK/UNK/2011
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kidney Stones]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pre-Diabetes]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911101
Page 8 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D Deficiency]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911102
Page 9 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [280.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [52.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911103
Page 10 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911104
Page 11 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [79261]
3.Randomization Group: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911105
Page 12 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BPTM5G]
5.bSample ID [BPTM5H]
5.cSample ID [BPTM5J]
5.dSample ID [BNTPB2]
5.eSample ID [BNTPB3]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911106
Page 13 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BPTM59]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911107
Page 14 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/3/2020 09:30
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
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911108
Page 15 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911109
Page 16 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911110
Page 17 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911111
Page 18 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911112
Page 19 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW2FH]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911113
Page 20 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/22/2020 12:35
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
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911114
Page 21 of 386
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911115
Page 22 of 386
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[After multiple attempts, it was unsuccessful]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911116
Page 23 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911117
Page 24 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911118
Page 25 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911119
Page 26 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911120
Page 27 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911121
Page 28 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911122
Page 29 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911123
Page 30 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/14/2021
2.Date of First Symptom Started: Jan/14/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/25/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911124
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/14/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
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(b) (4)
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Page 33 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/14/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [unknown]
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FDA-CBER-2021-5683-0911127
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[The subject did not do a self swab at the beginning and only did a swab at the
pcp. I was instructed by my monitor for the subject to perform a nasal swab
anyway even though she was recovered.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV12327]
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Page 35 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject had swab at pcp. Refused home swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
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Page 36 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911130
Page 37 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Jan/22/2021 NO
Discharge Date:
Jan/25/2021
Repeating Pages
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(b) (4)
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Page 38 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/22/2021
4.Ongoing? NO
Discharge Date:
Jan/25/2021
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Page 39 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment
IdentifierCon Non-Drug Tre
atments Pre-specifi
edTreatment TreatmentStart
DateForm Insta
nce
1.1 YES NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON NON-INVASIVE POSITIV
E PRESSURE VENTILATI
ON Jan/21
/2021 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0911133
Page 40 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1] Comments
2.Concomitant Non-drug Treatment
Pre-specified:YES Comments
3.Treatment: NON-INVASIVE POSITIVE PRESSURE VENTILATION Comments
4.Treatment: [NON-INVASIVE POSITIVE PRESSURE VENTILATION] Comments
5.Start Date: Jan/21/2021 Comments
6.Ongoing? NO
End Date:
Jan/25/2021Comments
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(b) (4)
FDA-CBER-2021-5683-0911134
Page 41 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[CoVid19]
Date of Diagnosis:
Jan/14/2021
3.Toxicity Grade: 2
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0911136
Page 43 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
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Page 44 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY Huntsville Hospital 101 Sivley
Rd SW, Huntsville, AL 35801 Jan/25/2
021 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
329 Not
Done
0.6
30 Not
Done
28
28 Not
Done
22
35 Not
Done
59
21 Not
Done
0.3
47 Not
Done
17
48 Not
Done
0.6 Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911138
Page 45 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Huntsville Hospital 101 Sivley Rd SW, Huntsville, AL 35801] Comments
3.Collection Date: Jan/25/2021 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [0.6] Comments
Not Done: Comments
LNMT Low
[0]
High
[>0.5]
Unit
mg/dLComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [28] Comments
Not Done: Comments
LNMT Low
[0]
High
[<32]
Unit
U/LComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911139
Page 46 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [22] Comments
Not Done: Comments
LNMT Low
[0]
High
[<33]
Unit
U/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [59] Comments
Not Done: Comments
LNMT Low
[39]
High
[119]
Unit
U/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [0.3] Comments
Not Done: Comments
LNMT Low
[0]
High
[<1.0]
Unit
mg/dLComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911140
Page 47 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [17] Comments
Not Done: Comments
LNMT Low
[6]
High
[20]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [0.6] Comments
Not Done: Comments
LNMT Low
[0.5]
High
[1.0]
Unit
mg/dLComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911141
Page 48 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY Huntsville Hospital 101 Sivley
Rd SW, Huntsville, AL 35801 Jan/25/2
021 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Not
Done 12.8
2 Not
Done 40.0
3 Not
Done 5.11
5 Not
Done 458
7 Not
Done 10.3
9
608 Not
Done 66.4
609 Not
Done 0.0
612 Not
Done 10.3
610 Not
Done 0.0
611 Not
Done 16.4
Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0911142
Page 49 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY Comments
2.Laboratory Name and Address [Huntsville Hospital 101 Sivley Rd SW, Huntsville, AL 35801] Comments
3.Collection Date: Jan/25/2021 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [12.8] Comments
Not Done: Comments
LNMT Low
[11.5]
High
[14.7]
Unit
g/LComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [40.0] Comments
Not Done: Comments
LNMT Low
[35.2]
High
[44.0]
Unit
%Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911143
Page 50 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [5.11] Comments
Not Done: Comments
LNMT Low
[4.00]
High
[4.90]
Unit
10^6/cu mmComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [458] Comments
Not Done: Comments
LNMT Low
[137]
High
[352]
Unit
10^3/uLComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [10.39] Comments
Not Done: Comments
LNMT Low
[4.10]
High
[12.20]
Unit
10^3/uLComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911144
Page 51 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [66.4] Comments
Not Done: Comments
LNMT Low
[0]
High
[0]
Unit
10^9/LComments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [0.0] Comments
Not Done: Comments
LNMT Low
[0]
High
[0]
Unit
10^9/LComments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [10.3] Comments
Not Done: Comments
LNMT Low
[0]
High
[0]
Unit
10^9/LComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911145
Page 52 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [0.0] Comments
Not Done: Comments
LNMT Low
[0]
High
[0]
Unit
10^9/LComments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [16.4] Comments
Not Done: Comments
LNMT Low
[0]
High
[0]
Unit
10^9/LComments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911146
Page 53 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Jan/21/2021 Record Identifier: Systolic: Diastolic:
Not Done 125 83 Repeating Pages
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(b) (4)
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Page 54 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021 Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125] Comments
Diastolic: [83] Comments
Respiratory Rate in
respirations/minute:[26] Comments
Heart Rate in beats/minute: [90] Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911148
Page 55 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Jan/21/2021 Record Identifier: Oxygen Saturation
Not Done 93.0 Repeating Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911149
Page 56 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021 Comments
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0] Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911150
Page 57 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Jan/24/2021 16:01 28 Not Done Repeating Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911151
Page 58 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Jan/24/2021 16:01 Comments
2.Arterial Blood Gases PaO2
(mmHg):[28] Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911152
Page 59 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for Medicatio
nConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. DELETED 1 GENERAL CONCOMIT
ANT MEDICATIONS NO Remdesivir Jan/21/
2021 Repeating
Pages
2. DELETED 2 GENERAL CONCOMIT
ANT MEDICATIONS NO Dexametha
sone Jan/21/
2021 Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911153
Page 60 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1] Comments
2.Category: GENERAL CONCOMITANT MEDICATIONS Comments
3.Concomitant Medications
Pre-specified:NO Comments
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).[Remdesivir ] Comments
5.Start Date: Jan/21/2021 Comments
6.Ongoing? NO
End Date:
Jan/25/2021Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911154
Page 61 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: GENERAL CONCOMITANT MEDICATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Dexamethasone ]
5.Start Date: Jan/21/2021
6.Ongoing? NO
End Date:
Jan/25/2021
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911155
Page 62 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessme
ntLocation of Assessme
ntImaging Meth
odOverall Assessment Form Instance
1.Jan/21/2021 CHEST CT SCAN ABNORMAL
If abnormal, specify findings:
pneumonia compatible with CoVi
d19
Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911156
Page 63 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/21/2021 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: CT SCAN Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[pneumonia compatible with CoVid19]Comments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911157
Page 64 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911158
Page 65 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/23/2021
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 [BJS6WW]
5.bSample ID [BJS6WX]
5.cSample ID [BJS6WY]
5.dSample ID [BPJ20W]
5.eSample ID [BPJ20X]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911159
Page 66 of 386
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911160
Page 67 of 386
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911161
Page 68 of 386
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911162
Page 69 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911163
Page 70 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911164
Page 71 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911165
Page 72 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 CoVid19 Jan/14/2021 08:
00 NO
End Date Time:
Jan/25/2021 14:00
Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911166
Page 73 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CoVid19]
4.Start Date Time: Jan/14/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/25/2021 14:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911167
Page 74 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021178864]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911168
Page 75 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911169
Page 76 of 386
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911170
Page 77 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911171
Page 78 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911172
Page 79 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911173
Page 80 of 386
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911174
Page 81 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911175
Page 82 of 386
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911176
Page 83 of 386
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911177
Page 84 of 386
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911178
Page 85 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911179
Page 86 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911180
Page 87 of 386
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911181
Page 88 of 386
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911182
Page 89 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911183
Page 90 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911184
Page 91 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911185
Page 92 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911186
Page 93 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911187
Page 94 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911188
Page 95 of 386
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911189
Page 96 of 386
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911190
Page 97 of 386
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911191
Page 98 of 386
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911192
Page 99 of 386
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911193
Page 100 of 386
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911194
Page 101 of 386
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911195
Page 102 of 386
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911196
Page 103 of 386
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911197
Page 104 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/21/2020
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911198
Page 105 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911199
Page 106 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ernest Hendrix Approved Mar-11-2021 15:27:43 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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.
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911200
Page 107 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-03-2020 14:39:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911201
Page 108 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911202
Page 109 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911203
Page 110 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911204
Page 111 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911205
Page 112 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911206
Page 113 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
5Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911207
Page 114 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-09-2021 12:35:28 (UTC-06:00) Central
Time (US & Canada)
6Jan-15-2021 18:02:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911208
Page 115 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:37:33 (UTC-06:00) Central
Time (US & Canada)Not Done
FormFeb-09-2021 12:37:11 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:02:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911209
Page 116 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 12:37:33 (UTC-06:00) Central
Time (US & Canada)Not Done
1Feb-09-2021 12:37:11 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:02:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911210
Page 117 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 12:37:33 (UTC-06:00) Central
Time (US & Canada)Not Done
2Feb-09-2021 12:37:11 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:02:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911211
Page 118 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 12:37:33 (UTC-06:00) Central
Time (US & Canada)Not Done
3Feb-09-2021 12:37:11 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:02:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911212
Page 119 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 12:37:33 (UTC-06:00) Central
Time (US & Canada)Not Done
4Feb-09-2021 12:37:11 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:02:41 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911213
Page 120 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911214
Page 121 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911215
Page 122 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911216
Page 123 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911217
Page 124 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911218
Page 125 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911219
Page 126 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911220
Page 127 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911221
Page 128 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911222
Page 129 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911223
Page 130 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911224
Page 131 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911225
Page 132 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911226
Page 133 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911227
Page 134 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911228
Page 135 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911229
Page 136 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911230
Page 137 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911231
Page 138 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911232
Page 139 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911233
Page 140 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911234
Page 141 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911235
Page 142 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911236
Page 143 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911237
Page 144 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911238
Page 145 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911239
Page 146 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911240
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911241
Page 148 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911242
Page 149 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911243
Page 150 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911244
Page 151 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911245
Page 152 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:37:51 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:02:54 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911246
Page 153 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911247
Page 154 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911248
Page 155 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911249
Page 156 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911250
Page 157 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911251
Page 158 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911252
Page 159 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911253
Page 160 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911254
Page 161 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.aJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911255
Page 162 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911256
Page 163 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911257
Page 164 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911258
Page 165 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.bJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911259
Page 166 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911260
Page 167 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911261
Page 168 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911262
Page 169 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.cJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911263
Page 170 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911264
Page 171 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911265
Page 172 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911266
Page 173 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.dJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911267
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911268
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911269
Page 176 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911270
Page 177 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.eJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911271
Page 178 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911272
Page 179 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911273
Page 180 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911274
Page 181 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 fJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911275
Page 182 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911276
Page 183 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911277
Page 184 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911278
Page 185 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.gJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911279
Page 186 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 hJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911280
Page 187 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 hJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911281
Page 188 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 hJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911282
Page 189 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5 hJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911283
Page 190 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.iJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911284
Page 191 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.iJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911285
Page 192 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.iJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911286
Page 193 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.iJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911287
Page 194 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.jJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911288
Page 195 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.jJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911289
Page 196 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.jJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911290
Page 197 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-09-2021 12:48:45 (UTC-06:00) Central
Time (US & Canada)
5.jJan-15-2021 18:03:08 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911291
Page 198 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911292
Page 199 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911293
Page 200 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
2.aJan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911294
Page 201 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
2.aJan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911295
Page 202 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
2.aJan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911296
Page 203 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 13:01:21 (UTC-06:00) Central
Time (US & Canada)
2.aJan-15-2021 18:03:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911297
Page 204 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:02:16 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:03:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911298
Page 205 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 13:02:16 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:03:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911299
Page 206 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-09-2021 13:02:16 (UTC-06:00) Central
Time (US & Canada)
2.aJan-15-2021 18:03:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911300
Page 207 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:05:42 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:03:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911301
Page 208 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 13:05:42 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:03:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911302
Page 209 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 13:05:42 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:03:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911303
Page 210 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 13:08:56 (UTC-06:00) Central
Time (US & Canada)Not Done
3Feb-09-2021 13:05:42 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:03:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911304
Page 211 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911305
Page 212 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911306
Page 213 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911307
Page 214 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911308
Page 215 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911309
Page 216 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
5Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911310
Page 217 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Feb-09-2021 13:09:31 (UTC-06:00) Central
Time (US & Canada)
6Jan-15-2021 18:03:57 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911311
Page 218 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-09-2021 13:21:41 (UTC-06:00) Central
Time (US & Canada)
FormJan-15-2021 18:04:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911312
Page 219 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-09-2021 13:21:41 (UTC-06:00) Central
Time (US & Canada)
1Jan-15-2021 18:04:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911313
Page 220 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-09-2021 13:21:41 (UTC-06:00) Central
Time (US & Canada)
2Jan-15-2021 18:04:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911314
Page 221 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-09-2021 13:21:41 (UTC-06:00) Central
Time (US & Canada)
3Jan-15-2021 18:04:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911315
Page 222 of 386
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/14/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-09-2021 13:21:41 (UTC-06:00) Central
Time (US & Canada)
4Jan-15-2021 18:04:09 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911316
Page 223 of 386
***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: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Ernest Hendrix Approved Mar-11-2021 15:27:43 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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-15-2021 18:00:37 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Ernest Hendrix Approved Oct-27-2020 13:44:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ErnestHendrix, 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.
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0911317
Page 224 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 12:07:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 12:07:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911318
Page 225 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 12:07:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911319
Page 226 of 386
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 12:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10461175Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 12:06:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1988Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 12:07:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 12:07:24
(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
Sep-03-2020 12:07:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(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-2021-5683-0911320
Page 227 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 12:07:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911321
Page 228 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 12:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 12:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 12:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911322
Page 229 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 12:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:ADHD
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 12:08:37
(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
Sep-03-2020 12:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ADHDInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 12:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 12:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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-2021-5683-0911323
Page 230 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Sep-03-2020 12:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:GERD
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 12:09:09
(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
Sep-03-2020 12:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 12:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 12:09:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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-2021-5683-0911324
Page 231 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-03-2020 12:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Kidney Stone
s
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 12:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 12:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Kidney StonesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 12:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 12:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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-2021-5683-0911325
Page 232 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-03-2020 12:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Pre-Diabetes
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 12:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 12:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Pre-DiabetesInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 12:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 12:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 12:10:31
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 5Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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-2021-5683-0911326
Page 233 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) er:
Medical History
Term:Vitamin D Defi
ciency
Start Date: UNK/UNK/200
9
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 12:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 12:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vitamin D DeficiencyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020 12:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020 12:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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-2021-5683-0911327
Page 234 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
280.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
52.9Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911328
Page 235 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 12:11:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911329
Page 236 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911330
Page 237 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020 12:11:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911331
Page 238 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 14:40:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 14:40:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
79261Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911332
Page 239 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 12:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 12:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 14:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 12:11:35
(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.
Sep-03-2020 12:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 14:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTM5GInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911333
Page 240 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 14:41:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTM5GInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 14:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTM5HInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 14:41:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTM5HInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 14:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTM5JInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 14:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTM5JInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020 14:42:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTPB2Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911334
Page 241 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 14:42:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTPB2Initial Entry
5.e
Date Location User Value Reason
Sep-03-2020 14:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNTPB3Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 14:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNTPB3Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911335
Page 242 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 12:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 12:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 14:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 12:11:42
(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.
Sep-03-2020 12:11:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 14:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTM59Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911336
Page 243 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 14:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTM59Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911337
Page 244 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 12:11:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 14:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 14:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 14:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 09:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 14:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 14:41:16
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0911338
Page 245 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-03-2020 14:41:16
(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
Sep-03-2020 14:41:16
(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
Sep-03-2020 12:11:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911339
Page 246 of 386
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 12:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911340
Page 247 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020 12:34:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911341
Page 248 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911342
Page 249 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-22-2020 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911343
Page 250 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911344
Page 251 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020 12:34:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911345
Page 252 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 12:35:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 12:35:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 12:35:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 12:35:04
(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.
Sep-22-2020 12:35:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 12:35:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPW2FHInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911346
Page 253 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 12:35:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPW2FHInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911347
Page 254 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 12:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020 12:35:31
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0911348
Page 255 of 386
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-22-2020 12:35:31
(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
Sep-22-2020 12:35:31
(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
Sep-22-2020 12:35:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911349
Page 256 of 386
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 15:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911350
Page 257 of 386
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 15:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 15:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 15:43:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-21-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Oct-21-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 15:43:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
090177e196ae4031\Final\Final On: 01-Apr-2021 05:32 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911351
Page 258 of 386
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1046 Site Name: (1046) North Alabama Research Center, LLC
Subject No: 10461175 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-21-2020 15:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 15:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
4. If no sample was collect
…[truncated]