Document text
Page 1 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802193
Page 2 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/18/2020
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802194
Page 3 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291127]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802195
Page 4 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802196
Page 5 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802197
Page 6 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802198
Page 7 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[drug allergies: restoril]
Start Date: UNK/UNK/1989
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diverticulitis]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[colon polyps]
Start Date: May/18/2020
Ongoing: NO
End Date:
May/18/2020
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hemorrhoids]
Start Date: May/UNK/2020
Ongoing: YES
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802199
Page 8 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[near sighted]
Start Date: UNK/UNK/2015
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gout]
Start Date: UNK/UNK/2013
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetes type 2]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[atrial fibrillation]
Start Date: UNK/UNK/2015
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802200
Page 9 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post traumatic stress disorder]
Start Date: UNK/UNK/2010
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tobacco user]
Start Date: UNK/UNK/1990
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anemia]
Start Date: Mar/16/2000
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802201
Page 10 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [188.8]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [27.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802202
Page 11 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [232246]
3.Randomization Group: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802203
Page 12 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BP5PFG]
5.bSample ID [BP5PFH]
5.cSample ID [BP5PFJ]
5.dSample ID [BLD10G]
5.eSample ID [BLD10H]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802204
Page 13 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/18/2020
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 [BMB56F]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802205
Page 14 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/18/2020 16:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802206
Page 15 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802207
Page 16 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802208
Page 17 of 369
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802209
Page 18 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN69JT]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802210
Page 19 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/8/2020 14:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802211
Page 20 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802212
Page 21 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BLB4SK]
5.bSample ID [BLB4SL]
5.cSample ID [BN69BH]
5.dSample ID [BN69BJ]
5.eSample ID [BN69BG]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802213
Page 22 of 369
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802214
Page 23 of 369
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:[Please reference samples recorded under Convalescent Visit A from
2March2021, completed the same day]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802215
Page 24 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802216
Page 25 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802217
Page 26 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802218
Page 27 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802219
Page 28 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802220
Page 29 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/1/2021
2.Date of First Symptom Started: Jan/16/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802221
Page 30 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.aSymptoms - Other Text: [fatigue]
5.bSymptoms - Other Text: [headache]
5.cSymptoms - Other Text: [lower back pain] Comments
5.dSymptoms - Other Text: [neck pain] Comments
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802222
Page 31 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/23/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802223
Page 32 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/23/2021
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: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA-certified lab]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802224
Page 33 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/1/2021
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 [CV58381]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802225
Page 34 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802226
Page 35 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802227
Page 36 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802228
Page 37 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Jan/20/2021 NO
Discharge Date:
Jan/26/2021
Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802229
Page 38 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/20/2021
4.Ongoing? NO
Discharge Date:
Jan/26/2021
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802230
Page 39 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802231
Page 40 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802232
Page 41 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
[Sepsis]
Date of Diagnosis:
Jan/20/2021
3.Toxicity Grade: 3
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802233
Page 42 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category of Clinical Event
:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802234
Page 43 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802235
Page 44 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.CLINICAL
CHEMISTR
Y Baptist Medical Center So
uth.
14550 St. Augustine Road
, Jacksonville, FL 32258-
2460 Jan/26/2
021 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosp
hatase_PX35 [ ]
21 Bilirubin_PX21
[ ]
47 Blood Urea Nitr
ogen_PX47 11
48 Creatinine_PX4
8 0.6
0 Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802236
Page 45 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
2.CLINICAL
CHEMISTR
Y Baptist Medical Center So
uth.
14550 St. Augustine Road
, Jacksonville, FL 32258-
2460 Jan/24/2
021 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prot
ein_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 101
28 Aspartate Amin
otransferase_PX
28 87
35 Alkaline Phosp
hatase_PX35 193
21 Bilirubin_PX21
1.9
47 Blood Urea Nitr
ogen_PX47 13
48 Creatinine_PX4
8 0.6
3 Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802237
Page 46 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Baptist Medical Center South.
14550 St. Augustine Road, Jacksonville, FL 32258-2460]
3.Collection Date: Jan/26/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802238
Page 47 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802239
Page 48 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [11]
Not Done:
LNMT Low
[7]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.60]
Not Done:
LNMT Low
[0.70]
High
[1.50]
Unit
mg/dL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802240
Page 49 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Baptist Medical Center South.
14550 St. Augustine Road, Jacksonville, FL 32258-2460]
3.Collection Date: Jan/24/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [101]
Not Done:
LNMT Low
[17]
High
[63]
Unit
U/L
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802241
Page 50 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [87]
Not Done:
LNMT Low
[15]
High
[41]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [193]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.9]
Not Done:
LNMT Low
[0.3]
High
[1.8]
Unit
mg/dL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802242
Page 51 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [13]
Not Done:
LNMT Low
[7]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.63]
Not Done:
LNMT Low
[0.70]
High
[1.50]
Unit
mg/dL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802243
Page 52 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY Baptist Medical Center Sout
h.
14550 St. Augustine Road, J
acksonville, FL 32258-2460 Jan/20/2
021 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 11.7
2 Hematocrit
_PX2 34.2
3 Erythrocyt
es_PX3 3.83
5 Platelets_P
X5 85
7 Leukocytes
_PX7 1.00
608 Neutrophil
s_PX608 .70
609 Eosinophil
s_PX609 [ ]
612 Monocytes
_PX612 11
610 Basophils_
PX610 [ ]
611 Lymphocyt
es_PX611 0.25
Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802244
Page 53 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category fo
r Lab TestVendor Name (DERIVED)Collecti
on Date:Specime
n TypeLab ResultForm Instan
ce
2.HEMATOL
OGY Baptist Medical Center Sout
h.
14550 St. Augustine Road, J
acksonville, FL 32258-2460 Jan/26/2
021 BLOOD
Sponsor-Defi
ned Identifie
rTest:Res
ult:
1 Hemoglobi
n_PX1 7.7
2 Hematocrit
_PX2 22.2
3 Erythrocyt
es_PX3 2.49
5 Platelets_P
X5 203
7 Leukocytes
_PX7 2.90
608 Neutrophil
s_PX608 1.8
609 Eosinophil
s_PX609 1
612 Monocytes
_PX612 14
610 Basophils_
PX610 1
611 Lymphocyt
es_PX611 23 Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802245
Page 54 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Baptist Medical Center South.
14550 St. Augustine Road, Jacksonville, FL 32258-2460]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [11.7]
Not Done:
LNMT Low
[13.3]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [34.2]
Not Done:
LNMT Low
[41.0]
High
[53.0]
Unit
%
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802246
Page 55 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [3.83]
Not Done:
LNMT Low
[4.30]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [85]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [1.00]
Not Done:
LNMT Low
[4.5]
High
[11.00]
Unit
10^3/uL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802247
Page 56 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [.70]
Not Done:
LNMT Low
[1.80]
High
[8.0]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [11]
Not Done:
LNMT Low
[3]
High
[15]
Unit
%
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802248
Page 57 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.25]
Not Done:
LNMT Low
[1.00]
High
[5.00]
Unit
10^3/uL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802249
Page 58 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Baptist Medical Center South.
14550 St. Augustine Road, Jacksonville, FL 32258-2460]
3.Collection Date: Jan/26/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [7.7]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [22.2]
Not Done:
LNMT Low
[41.0]
High
[53.0]
Unit
%
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802250
Page 59 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [2.49]
Not Done:
LNMT Low
[4.30]
High
[5.90]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [203]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [2.90]
Not Done:
LNMT Low
[4.50]
High
[11.00]
Unit
10^3/uL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802251
Page 60 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [1.8]
Not Done:
LNMT Low
[1.8]
High
[8.00]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [1]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [14]
Not Done:
LNMT Low
[3]
High
[15]
Unit
%
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802252
Page 61 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[2]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [23]
Not Done:
LNMT Low
[15]
High
[45]
Unit
%
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802253
Page 62 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
1. DELETED Jan/20/2021 Record Identifier: Systolic: Diastolic:
1 119 60 Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802254
Page 63 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
2.Jan/20/2021 Record Identifier: Systolic: Diastolic:
1 170 68 Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802255
Page 64 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Deleted, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [119]
Diastolic: [60]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [79]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802256
Page 65 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [170]
Diastolic: [68]
Respiratory Rate in
respirations/minute:[17]
Heart Rate in beats/minute: [97]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802257
Page 66 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
1.Jan/21/2021 Record Identifier: Oxygen Saturation
1 85.0 Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802258
Page 67 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Date: Vital Signs Details Form Instance
2.Jan/26/2021 Record Identifier: Oxygen Saturation
1 93.0 Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802259
Page 68 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [85.0]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802260
Page 69 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/26/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802261
Page 70 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802262
Page 71 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802263
Page 72 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#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 Amlodipine
Jan/21/
2021 Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802264
Page 73 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
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).[Amlodipine ]
5.Start Date: Jan/21/2021
6.Ongoing? YES
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802265
Page 74 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of A
ssessmentLocation of A
ssessmentImaging
MethodOverall AssessmentForm Instan
ce
1.Jan/20/202
1 OTHER
If other, spec
ify:
abdomen/p
elvis w/c
CT SCAN ABNORMAL
If abnormal, specify findings:
See form comment
Repeating
Pages
2.Jan/22/202
1 OTHER
If other, spec
ify:
abdominal
OTHER
If other, s
pecify:
MRCP
ABNORMAL
If abnormal, specify findings:
pancreatic ductal dilation. Calculus in the pancreatic duct
measures 7 mm. No biliary dilatation. Colonic diverticulo
sis
Repeating
Pages
3.Jan/20/202
1 CHEST X-RAY NORMAL Repeating
Pages
4.Jan/25/202
1 CHEST X-RAY NORMAL Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802266
Page 75 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: OTHER
If other, specify:
[abdomen/pelvis w/c]
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[See form comment]Comments
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802267
Page 76 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/22/2021
2.Location of Assessment: OTHER
If other, specify:
[abdominal]
3.Type of Imaging Exam: OTHER
If other, specify:
[MRCP]
4.Assessment: ABNORMAL
If abnormal, specify findings:
[pancreatic ductal dilation. Calculus in the pancreatic duct measures 7 mm. No
biliary dilatation. Colonic diverticulosis]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802268
Page 77 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802269
Page 78 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/25/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802270
Page 79 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/02/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802271
Page 80 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/02/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BMB5ND]
5.bSample ID [BMB5NF]
5.cSample ID [BMB5NG]
5.dSample ID [BMNCVH]
5.eSample ID [BMNCVJ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802272
Page 81 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802273
Page 82 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802274
Page 83 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802275
Page 84 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802276
Page 85 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802277
Page 86 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802278
Page 87 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Sepsis Jan/16/2021 UNK
:UNK NO
End Date Time:
Jan/26/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Pancytopenia Jan/20/2021 UNK
:UNK YES Repeating
Pages
3.ADVERSE EV
ENT 3 worsened hypertensi
on Jan/20/2021 UNK
:UNK YES Repeating
Pages
4.ADVERSE EV
ENT 4 neck pain Jan/16/2021 UNK
:UNK NO
End Date Time:
Jan/26/2021 UNK:UNK
Repeating
Pages
5.ADVERSE EV
ENT 5 intermittent lower ba
ck pain Jan/16/2021 UNK
:UNK NO
End Date Time:
Jan/16/2021 UNK:UNK
Repeating
Pages
6.ADVERSE EV
ENT 6 erosive gastropathy Jan/22/2021 UNK
:UNK YES Repeating
Pages
7.ADVERSE EV
ENT 7 Splenomegaly Jan/20/2021 UNK
:UNK YES Repeating
Pages
8.ADVERSE EV
ENT 8 Pancreatic Calculus Jan/20/2021 UNK
:UNK YES Repeating
Pages
9.ADVERSE EV
ENT 9 Gallstones Jan/22/2021 UNK
:UNK YES Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802279
Page 88 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[Sepsis]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802280
Page 89 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 Etiology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2021106956]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802281
Page 90 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pancytopenia]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
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
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802282
Page 91 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
[Due to sepsis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021106956]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802283
Page 92 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsened hypertension]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802284
Page 93 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802285
Page 94 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[neck pain]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[medical history of neck muscle spasms]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802286
Page 95 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802287
Page 96 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[intermittent lower back pain]
4.Start Date Time: Jan/16/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/16/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802288
Page 97 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802289
Page 98 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[erosive gastropathy]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[history of Gastroesophageal reflux disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802290
Page 99 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802291
Page 100 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Splenomegaly]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[etiology unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802292
Page 101 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802293
Page 102 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pancreatic Calculus]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[etiology unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802294
Page 103 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802295
Page 104 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Gallstones]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[etiology unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802296
Page 105 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802297
Page 106 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802298
Page 107 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802299
Page 108 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802300
Page 109 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: //
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802301
Page 110 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802302
Page 111 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802303
Page 112 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802304
Page 113 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802305
Page 114 of 369
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802306
Page 115 of 369
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802307
Page 116 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802308
Page 117 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802309
Page 118 of 369
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802310
Page 119 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802311
Page 120 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802312
Page 121 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802313
Page 122 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802314
Page 123 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802315
Page 124 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802316
Page 125 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802317
Page 126 of 369
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802318
Page 127 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802319
Page 128 of 369
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802320
Page 129 of 369
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802321
Page 130 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802322
Page 131 of 369
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802323
Page 132 of 369
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802324
Page 133 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-18-2020 17:46:33 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802325
Page 134 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5.cFeb-03-2021 14:21:39 (UTC-05:00) Eastern
Time (US & Canada)subject states pain was bone pain not muscular
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802326
Page 135 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5.dFeb-03-2021 14:22:06 (UTC-05:00) Eastern
Time (US & Canada)subject states pain was bone pain not muscular
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802327
Page 136 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormMar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802328
Page 137 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802329
Page 138 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802330
Page 139 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802331
Page 140 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802332
Page 141 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802333
Page 142 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6Mar-05-2021 12:49:56 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802334
Page 143 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormMar-05-2021 12:50:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802335
Page 144 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Mar-05-2021 12:50:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802336
Page 145 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Mar-05-2021 12:50:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802337
Page 146 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Mar-05-2021 12:50:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802338
Page 147 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Feb-04-2021 11:13:02 (UTC-05:00) Eastern
Time (US & Canada)CT findings compatible with chronic pancreatitis
with diffuse pancreatic atrophy and multiple
scattered pancreatic calcifications. 0.8 cm stone
in the pancreatic duct. Aortic and coronary artery
atherosclerosis. Splenomegaly. Colonic
diverticulosis
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802339
Page 148 of 369
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Alex Hill N/A Feb-02-2021 18:50:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Jan-21-2021 18:17:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, 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-14-2021 15:31:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Oct-22-2020 18:07:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, 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.
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802340
Page 149 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-18-2020 17:45:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020 17:45:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802341
Page 150 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 17:45:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/18/2020Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802342
Page 151 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 17:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11291127Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 17:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 17:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020 17:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020 17:46:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802343
Page 152 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 17:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802344
Page 153 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-18-2020 17:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 17:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 17:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802345
Page 154 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 17:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:drug allergies: r
estoril
Start Date: UNK/UNK/198
9
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
drug allergies: restorilInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-18-2020 17:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020 17:52:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802346
Page 155 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b
Date Location User Value Reason
Aug-18-2020 17:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:diverticulitis
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diverticulitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020 17:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-18-2020 17:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802347
Page 156 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-18-2020 17:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:3
Medical History
Term:colon polyps
Start Date: May/18/2020
Ongoing: NO
End Date:
May/18/2
020Transcription Error
Aug-18-2020 17:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History Te
rm:colon poly
ps
Start Date: May/18/20
20
Ongoing: NOInitial Entry
Aug-18-2020 17:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:colon poly
ps
Start Date:
Ongoing: NOInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802348
Page 157 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
colon polypsInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020 17:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/18/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020 17:58:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/18/2020Transcription Error
Aug-18-2020 17:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Aug-18-2020 17:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:hemorrhoids
Start Date: May/UNK/2
020Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802349
Page 158 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hemorrhoidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 17:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 17:55:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-18-2020 17:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:near sighted
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802350
Page 159 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
near sightedInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-18-2020 17:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-18-2020 17:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-18-2020 17:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:gout
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802351
Page 160 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
goutInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-18-2020 17:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-18-2020 17:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-18-2020 17:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:diabetes type
2
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802352
Page 161 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diabetes type 2Initial Entry
1.g Start Date:
Date Location User Value Reason
Aug-18-2020 17:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-18-2020 17:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-18-2020 17:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:atrial fibrillati
on
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802353
Page 162 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrillationInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-18-2020 17:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-18-2020 17:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-18-2020 17:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:insomnia
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802354
Page 163 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-18-2020 17:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-18-2020 17:57:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-18-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:post traumatic str
ess disorder
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802355
Page 164 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
post traumatic stress disorderInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-18-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-18-2020 17:57:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-18-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:tobacco user
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802356
Page 165 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Aug-18-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tobacco userInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-18-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-18-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Mar-10-2021 17:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Ter
m:anemia
Start Date: Mar/16/200
0
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802357
Page 166 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Mar-10-2021 17:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-12-2021 19:13:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Alex Hill Query 1: Answered Site confirms at Visit
1 subject reported no
to any "Receipt of
blood/plasma
products or
immunoglobulin,
from 0 days before
study intervention
administration or
planned receipt
throughout the
study."
Mar-11-2021 15:18:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Anemia
reported: Please
confirm if subject
has received any
blood products
within 60 days
before enrollment.
Mar-10-2021 17:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
anemiaInitial Entry
1.l Start Date:
Date Location User Value Reason
Mar-10-2021 17:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/16/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802358
Page 167 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-10-2021 17:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Mar-11-2021 12:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:13
Medical History T
erm:GERD
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802359
Page 168 of 369
***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, Answered Queries, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Mar-11-2021 12:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-11-2021 12:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.m Start Date:
Date Location User Value Reason
Mar-11-2021 12:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Mar-11-2021 12:45:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802360
Page 169 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 05:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-19-2020 10:33:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered non-clinically
significant
Aug-18-2020 17:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 188.8 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for
lb.
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
188.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 13:52:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-20-2020 13:52:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBTranscription Error
Aug-20-2020 13:52:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened kg is selected for
weight unit, then cm
is expected to be
selected for Height
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802361
Page 170 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
unit. Please check
and update data as
appropriate.
Aug-18-2020 17:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 17:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgTranscription Error
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened lb is selected for
weight unit, then in
is expected to be
selected for Height
unit. Please check
and update data as
appropriate.
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 13:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 13:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Transcription Error
Aug-20-2020 13:52:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Height 175.3 is
outside of Normal
Range 140 - 198 for
cm or 55 - 80 for in.
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
175.3Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802362
Page 171 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-20-2020 13:52:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inTranscription Error
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 07:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-20-2020 13:54:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Aug-20-2020 13:52:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.9Transcription Error
Aug-20-2020 13:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-20-2020 13:52:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-19-2020 22:54:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
can you review the
height/weight
combinations of this
subject as currently
the derived BMI is
much higher than
expected. Thanks
Aug-18-2020 17:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
61.4Transcription Error
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802363
Page 172 of 369
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.a
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.8
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020 17:47:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802364
Page 173 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 17:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 17:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
232246Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802365
Page 174 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 17:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 17:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 17:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 17:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PFGInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802366
Page 175 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 17:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PFGInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 17:25:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PFHInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 17:25:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PFHInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 17:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PFJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 17:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PFJInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 17:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD10GInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802367
Page 176 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 17:25:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD10GInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020 17:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD10HInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 17:26:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD10HInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802368
Page 177 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 17:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 17:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 17:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 17:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-19-2020 17:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 17:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMB56FInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802369
Page 178 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 17:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMB56FInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802370
Page 179 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/18/2020 16:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802371
Page 180 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-18-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802372
Page 181 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 03:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site confirmation
Sep-03-2020 09:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 09:52:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTTranscription Error
Sep-03-2020 03:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are not
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-18-2020 17:48:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802373
Page 182 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 16:44:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802374
Page 183 of 369
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.8
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802375
Page 184 of 369
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 16:45:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802376
Page 185 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 10:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 10:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 10:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 10:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-09-2020 10:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020 10:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN69JTInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802377
Page 186 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 10:45:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN69JTInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802378
Page 187 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 14:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802379
Page 188 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 16:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802380
Page 189 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 16:23:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802381
Page 190 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 16:29:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 16:29:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 16:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 16:29:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 16:29:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020 16:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB4SKInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802382
Page 191 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 16:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB4SKInitial Entry
5.b
Date Location User Value Reason
Oct-08-2020 16:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB4SLInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 16:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB4SLInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 16:29:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN69BHInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 16:29:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN69BHInitial Entry
5.d
Date Location User Value Reason
Oct-08-2020 16:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN69BJInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802383
Page 192 of 369
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Oct-08-2020 16:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN69BJInitial Entry
5.e
Date Location User Value Reason
Oct-08-2020 16:30:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN69BGInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-08-2020 16:30:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN69BGInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802384
Page 193 of 369
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 15:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2021Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802385
Page 194 of 369
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 15:24:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 15:24:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 15:29:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-03-2021 15:28:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Mar-03-2021 15:28:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 15:28:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802386
Page 195 of 369
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-03-2021 15:24:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-03-2021 15:24:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-03-2021 15:29:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Please reference samples recorde
d under Convalescent Visit A fro
m 2March2021, completed the sa
me dayInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802387
Page 196 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 10:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 07:16:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-03-2021 14:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-03-2021 14:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Feb-03-2021 14:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802388
Page 197 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-03-2021 14:18:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802389
Page 198 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-12-2021 12:09:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-11-2021 15:54:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-11-2021 15:54:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/16/2021Transcription Error
Feb-10-2021 13:12:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Source seems to
indicate that the
symptoms started
on 16 Jan 2021.
Please confirm.
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/10/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802390
Page 199 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802391
Page 200 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.c
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802392
Page 201 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.d Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-03-2021 14:19:47 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802393
Page 202 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NO
4.f Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802394
Page 203 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.h
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-03-2021 14:19:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802395
Page 204 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Feb-03-2021 14:20:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: fatigueInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 14:20:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
5.b
Date Location User Value Reason
Feb-03-2021 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: headacheInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
headacheInitial Entry
5.c
Date Location User Value Reason
Feb-03-2021 14:21:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Oth
er:lower back pa
inInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 14:21:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
lower back painInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (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-2021-5683-0802396
Page 205 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d
Date Location User Value Reason
Feb-03-2021 14:21:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: neck painInitial Entry
5.d Symptoms - Other Text:
Date Location User Value Reason
Feb-03-2021 14:21:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
neck painInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802397
Page 206 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802398
Page 207 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/23/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802399
Page 208 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
7. Test Result:
Date Location User Value Reason
Feb-03-2021 14:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-10-2021
03:42:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedQuery closed
data has been
updated
Feb-09-2021
09:09:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dTranscription
Error
Feb-09-2021
09:09:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
CLIA-cer
tified labTranscription
Error
Feb-09-2021
05:50:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedDM: Please
indicate
whether the test
was conducted
in a CLIA-
certified
laboratory by
including the
text ‘CLIA-
certified lab’ in
the required
field, Thank
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0802400
Page 209 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
you.
Feb-08-2021
03:25:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Feb-05-2021
16:42:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dTranscription
Error
Feb-05-2021
16:42:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
CLIA 10
D026874
8Transcription
Error
Feb-05-2021
02:45:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
Openedbmcj laboratory
is not indicated
on the FDA
cleared
(including
Emergency Use
Authorization)
diagnostic list
and is not
indicated as
CLIA certified
lab or ISO
15189
accredited lab .
Please verify
and update as
appropriate.
Otherwise,
please provide
clarification.
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802401
Page 210 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-03-2021
14:50:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
BMCJ L
aboratoryInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0802402
Page 211 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 10:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 10:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 10:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 10:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV58381Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802403
Page 212 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 10:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CV58381Initial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802404
Page 213 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-04-2021 11:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
self swab collectedInitial Entry
090177e196ae30b1\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802405
Page 214 of 369
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291127 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Feb-03-2021 14:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
one
…[truncated]