125742 S1 M5 CRF c4591001 1109 11091448

Document text

Page 1 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978144
Page 2 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978145
Page 3 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11091448]
2.Birth Date: 1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0978146
Page 4 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978147
Page 5 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978148
Page 6 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978149
Page 7 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POSTMENOPAUSAL]
Start Date: UNK/UNK/2006
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYSTERECTOMY]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FIBROMYALGIA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO AUGMENTIN]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978150
Page 8 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO BIAXIN]
Start Date: UNK/UNK/2005
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO KEFLEX]
Start Date: UNK/UNK/1995
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO SEPTRA]
Start Date: UNK/UNK/2008
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO LATEX]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemiplegic Migraine]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978151
Page 9 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Headaches]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978152
Page 10 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [182.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [29.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978153
Page 11 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978154
Page 12 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [84116]
3.Randomization Group: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978155
Page 13 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
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 [BMNGPG]
5.bSample ID [BMNGPH]
5.cSample ID [BPXSR2]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978156
Page 14 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [BPXSRG]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978157
Page 15 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 15:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978158
Page 16 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978159
Page 17 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978160
Page 18 of 343
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978161
Page 19 of 343
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978162
Page 20 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
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 [BPXTHJ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978163
Page 21 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/28/2020 08:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978164
Page 22 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978165
Page 23 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [BR84VN]
5.bSample ID [BS6C3S]
5.cSample ID [BS6C3T]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978166
Page 24 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978167
Page 25 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/28/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978168
Page 26 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978169
Page 27 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/21/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978170
Page 28 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/21/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [NALT Unknown] Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978171
Page 29 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Oct/9/2020Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV07005]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978172
Page 30 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978173
Page 31 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978174
Page 32 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.[ ]      [ ]    Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978175
Page 33 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978176
Page 34 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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:
[COVID-19 Infection]
Date of Diagnosis:
Oct/21/2020
3.Toxicity Grade: 3
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978177
Page 35 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978178
Page 36 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978179
Page 37 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978180
Page 38 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978181
Page 39 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978182
Page 40 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978183
Page 41 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978184
Page 42 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978185
Page 43 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978186
Page 44 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978187
Page 45 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978188
Page 46 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978189
Page 47 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978190
Page 48 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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.Start Date: //
6.Ongoing?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978191
Page 49 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978192
Page 50 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978193
Page 51 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978194
Page 52 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Done
//Comments
2.Date of First Symptom Started: Not Done
//Comments
3.Symptoms Ongoing? Not Done Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Done Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Done Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Done Comments
4.dSymptoms: CHILLS
Was symptom present? Not Done Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Done Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Done Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978195
Page 53 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Done Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Done Comments
4.iSymptoms: VOMITING
Was symptom present? Not Done Comments
Symptoms - Other
5.Symptoms - Other Text: Not Done
[ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978196
Page 54 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978197
Page 55 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978198
Page 56 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978199
Page 57 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978200
Page 58 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Done Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Done Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Done Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Done Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Done Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Done Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Done
[ ]Comments
Health Care Utilization
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978201
Page 59 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Done Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978202
Page 60 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978203
Page 61 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978204
Page 62 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Done Comments
3.Toxicity Grade: Not Done Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978205
Page 63 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978206
Page 64 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978207
Page 65 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978208
Page 66 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978209
Page 67 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978210
Page 68 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978211
Page 69 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978212
Page 70 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978213
Page 71 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978214
Page 72 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978215
Page 73 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978216
Page 74 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978217
Page 75 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978218
Page 76 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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.Start Date: //
6.Ongoing?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978219
Page 77 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978220
Page 78 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978221
Page 79 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978222
Page 80 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/06/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BR84WZ]
5.bSample ID [BS6C83]
5.cSample ID [BS6C84]
5.dSample ID [BSGWP8]
5.eSample ID [BSGWP9]
5.fSample ID [BS6C84]
5.gSample ID [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978223
Page 81 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/20/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Done Comments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978224
Page 82 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978225
Page 83 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978226
Page 84 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978227
Page 85 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978228
Page 86 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978229
Page 87 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Oct/23/2020Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: COVID_AR1
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978230
Page 88 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Oct/23/2020Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
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 [BR84RN]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978231
Page 89 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instance
 1.ADVERSE EV
ENT 1  Hemiplegic Migr
aine Oct/20/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978232
Page 90 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Hemiplegic Migraine]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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
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:
[Related to subjects history of headaches]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978233
Page 91 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?: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[2020413365]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978234
Page 92 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978235
Page 93 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978236
Page 94 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978237
Page 95 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: //
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978238
Page 96 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978239
Page 97 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978240
Page 98 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978241
Page 99 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978242
Page 100 of 343
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978243
Page 101 of 343
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978244
Page 102 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978245
Page 103 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978246
Page 104 of 343
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978247
Page 105 of 343
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978248
Page 106 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978249
Page 107 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978250
Page 108 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978251
Page 109 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978252
Page 110 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978253
Page 111 of 343
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978254
Page 112 of 343
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978255
Page 113 of 343
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978256
Page 114 of 343
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978257
Page 115 of 343
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978258
Page 116 of 343
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978259
Page 117 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978260
Page 118 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978261
Page 119 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978262
Page 120 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormSep-08-2020 16:06:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978263
Page 121 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978264
Page 122 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978265
Page 123 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978266
Page 124 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978267
Page 125 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978268
Page 126 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
5Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978269
Page 127 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
6Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978270
Page 128 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
7Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978271
Page 129 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
8Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
8Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978272
Page 130 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
9Oct-29-2020 11:04:14 (UTC-05:00) Eastern
Time (US & Canada)
9Oct-14-2020 10:14:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978273
Page 131 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-09-2020 16:07:04 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-09-2020 16:04:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978274
Page 132 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-09-2020 16:07:04 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-09-2020 16:04:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978275
Page 133 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-09-2020 16:07:04 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-09-2020 16:04:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978276
Page 134 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-09-2020 16:07:04 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-09-2020 16:04:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978277
Page 135 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-09-2020 16:07:04 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-09-2020 16:04:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978278
Page 136 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-30-2020 09:37:33 (UTC-05:00) Eastern
Time (US & Canada)Not Done
FormOct-29-2020 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-09-2020 16:06:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978279
Page 137 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-30-2020 09:37:33 (UTC-05:00) Eastern
Time (US & Canada)Not Done
1Oct-29-2020 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-09-2020 16:06:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978280
Page 138 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-30-2020 09:37:33 (UTC-05:00) Eastern
Time (US & Canada)Not Done
2Oct-29-2020 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-09-2020 16:06:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978281
Page 139 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-30-2020 09:37:33 (UTC-05:00) Eastern
Time (US & Canada)Not Done
3Oct-29-2020 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-09-2020 16:06:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978282
Page 140 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-30-2020 09:37:33 (UTC-05:00) Eastern
Time (US & Canada)Not Done
4Oct-29-2020 10:59:31 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-09-2020 16:06:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978283
Page 141 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:08:54 (UTC-05:00) Eastern
Time (US & Canada)All information was moved from this illness
visit to the one that occurred on 09Oct2020 due
to be within 4 days of end of symptoms per
protocol.
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978284
Page 142 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978285
Page 143 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978286
Page 144 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978287
Page 145 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978288
Page 146 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.aOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978289
Page 147 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.bOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978290
Page 148 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.cOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978291
Page 149 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.dOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978292
Page 150 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.eOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978293
Page 151 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4 fOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978294
Page 152 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.gOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978295
Page 153 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4 hOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978296
Page 154 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4.iOct-29-2020 11:07:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978297
Page 155 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978298
Page 156 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978299
Page 157 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978300
Page 158 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978301
Page 159 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978302
Page 160 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978303
Page 161 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
6Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978304
Page 162 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
7Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978305
Page 163 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
8Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978306
Page 164 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
9Oct-29-2020 11:06:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978307
Page 165 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-23-2020 16:40:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978308
Page 166 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-23-2020 16:40:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978309
Page 167 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-23-2020 16:40:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978310
Page 168 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-23-2020 16:40:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978311
Page 169 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Oct-23-2020 16:40:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978312
Page 170 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormMar-03-2021 16:46:56 (UTC-05:00) Eastern
Time (US & Canada)This visit was moved to the first COVID illness
visit as it occurred within 4 days from stop of
last symptom from first visit.
Not Done
FormNov-09-2020 18:01:47 (UTC-05:00) Eastern
Time (US & Canada)
FormOct-29-2020 11:02:20 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978313
Page 171 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Mar-03-2021 16:46:56 (UTC-05:00) Eastern
Time (US & Canada)This visit was moved to the first COVID illness
visit as it occurred within 4 days from stop of last
symptom from first visit.
Not Done
1Nov-09-2020 18:01:47 (UTC-05:00) Eastern
Time (US & Canada)
1Oct-29-2020 11:02:20 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978314
Page 172 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Mar-03-2021 16:46:56 (UTC-05:00) Eastern
Time (US & Canada)This visit was moved to the first COVID illness
visit as it occurred within 4 days from stop of last
symptom from first visit.
Not Done
2Nov-09-2020 18:01:47 (UTC-05:00) Eastern
Time (US & Canada)
2Oct-29-2020 11:02:20 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978315
Page 173 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Mar-03-2021 16:46:56 (UTC-05:00) Eastern
Time (US & Canada)This visit was moved to the first COVID illness
visit as it occurred within 4 days from stop of last
symptom from first visit.
Not Done
3Nov-09-2020 18:01:47 (UTC-05:00) Eastern
Time (US & Canada)
3Oct-29-2020 11:02:20 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978316
Page 174 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Mar-03-2021 16:46:56 (UTC-05:00) Eastern
Time (US & Canada)This visit was moved to the first COVID illness
visit as it occurred within 4 days from stop of last
symptom from first visit.
Not Done
4Nov-09-2020 18:01:47 (UTC-05:00) Eastern
Time (US & Canada)
4Oct-29-2020 11:02:20 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978317
Page 175 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
5.aNov-09-2020 18:02:23 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978318
Page 176 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978319
Page 177 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1.aOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978320
Page 178 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1.bOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978321
Page 179 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1.cOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978322
Page 180 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1.dOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978323
Page 181 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1.eOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978324
Page 182 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1 fOct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978325
Page 183 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978326
Page 184 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-29-2020 11:03:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978327
Page 185 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/23/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormOct-29-2020 11:07:49 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978328
Page 186 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Oct-29-2020 11:07:49 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978329
Page 187 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Oct-29-2020 11:07:49 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978330
Page 188 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Oct-29-2020 11:07:49 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978331
Page 189 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Dec-17-2020 10:17:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978332
Page 190 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormDec-17-2020 10:18:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978333
Page 191 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
1Dec-17-2020 10:18:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978334
Page 192 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
2Dec-17-2020 10:18:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978335
Page 193 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
3Dec-17-2020 10:18:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978336
Page 194 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
4Dec-17-2020 10:18:08 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978337
Page 195 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-09-2021 15:01:06 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Jan-20-2021 14:00:23 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-16-2020 07:43:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Nov-24-2020 16:54:58 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0978338
Page 196 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
 N/A Nov-20-2020 09:11:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Nov-10-2020 08:47:29 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-07-2020 13:18:19 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Nov-06-2020 18:27:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-06-2020 13:17:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0978339
Page 197 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Bruce Rankin  Approved Nov-02-2020 12:17:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-26-2020 16:13:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Oct-26-2020 12:50:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, BruceRankin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-23-2020 16:31:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Bruce Rankin  Approved Oct-16-2020 15:14:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0978340
Page 198 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, BruceRankin, 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.
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978341
Page 199 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-08-2020 16:05:19
(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
Sep-08-2020 16:05:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978342
Page 200 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020 16:05:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/8/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978343
Page 201 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-08-2020 16:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11091448Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020 16:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020 16:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 16:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-08-2020 16:05:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
FDA-CBER-2021-5683-0978344
Page 202 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 16:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978345
Page 203 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-08-2020 16:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020 16:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020 16:09:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978346
Page 204 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Sep-08-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:POSTMENOPA
USAL
Start Date: UNK/UNK/200
6
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:10:02
(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
Sep-08-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSTMENOPAUSALInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-08-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-08-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978347
Page 205 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b
Date Location User Value Reason
Sep-08-2020 16:10:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:HYSTERECTO
MY
Start Date: UNK/UNK/200
6
Ongoing: NO
End Date:
UNK/UNK/
2006Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978348
Page 206 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:10:44
(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
Sep-08-2020 16:10:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYSTERECTOMYInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-08-2020 16:10:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-08-2020 16:10:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.c
Date Location User Value Reason
Sep-08-2020 16:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:FIBROMYAL
GIA
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978349
Page 207 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.c Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:11:09
(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
Sep-08-2020 16:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FIBROMYALGIAInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-08-2020 16:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-08-2020 16:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-08-2020 16:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:ALLERGY TO A
UGMENTIN
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978350
Page 208 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:12:53
(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
Sep-08-2020 16:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO AUGMENTINInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-08-2020 16:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-08-2020 16:12:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-08-2020 16:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:ALLERGY TO
BIAXIN
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978351
Page 209 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:13:12
(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
Sep-08-2020 16:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO BIAXINInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-08-2020 16:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-08-2020 16:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-08-2020 16:13:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:ALLERGY TO
KEFLEX
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978352
Page 210 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:13:36
(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
Sep-08-2020 16:13:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO KEFLEXInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-08-2020 16:13:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-08-2020 16:13:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-08-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:ALLERGY TO S
EPTRA
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978353
Page 211 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:13:59
(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
Sep-08-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO SEPTRAInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-08-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-08-2020 16:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-08-2020 16:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:ALLERGY TO
LATEX
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978354
Page 212 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.h Line/MH Number:
Date Location User Value Reason
Sep-08-2020 16:14:19
(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
Nov-02-2020 06:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Closed Response satisfies
query
Oct-30-2020 10:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-30-2020 01:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:Hemiplegic
Migraine: Question 9
states this is related to
subjects medhx of
headaches but this is
not listed in subjects'
medhx. Please
review/update as
appropriate. Thanks
Sep-08-2020 16:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO LATEXInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-08-2020 16:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-08-2020 16:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978355
Page 213 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.i
Date Location User Value Reason
Oct-30-2020 10:08:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Hemiplegic Mi
graine
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Oct-30-2020 10:08:35
(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
Oct-30-2020 10:08:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hemiplegic MigraineInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-30-2020 10:08:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-30-2020 10:08:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978356
Page 214 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-30-2020 10:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History T
erm:Headaches
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
FDA-CBER-2021-5683-0978357
Page 215 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Oct-30-2020 10:08:56
(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
Oct-30-2020 10:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HeadachesInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-30-2020 10:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-30-2020 10:08:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978358
Page 216 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
182.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.4Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978359
Page 217 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 99.1
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 16:24:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978360
Page 218 of 343
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020 16:24:19 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978361
Page 219 of 343
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 16:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978362
Page 220 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-08-2020 16:31:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-08-2020 16:31:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
84116Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978363
Page 221 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 07:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 04:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Sep-08-2020 16:32:08
(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-08-2020 16:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978364
Page 222 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Sep-09-2020 07:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNGPGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 07:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNGPGInitial Entry
5.b
Date Location User Value Reason
Sep-09-2020 07:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNGPHInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-09-2020 07:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNGPHInitial Entry
5.c
Date Location User Value Reason
Sep-09-2020 07:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXSR2Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-09-2020 07:18:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXSR2Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0978365
Page 223 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 16:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 16:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 07:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 04:56:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Sep-08-2020 16:32:16
(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-08-2020 16:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978366
Page 224 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a
Date Location User Value Reason
Sep-09-2020 07:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXSRGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 07:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXSRGInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978367
Page 225 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 16:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 16:32:38
(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 16:32:38
(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 16:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 15:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 16:32:38
(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 16:32:38
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978368
Page 226 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-08-2020 16:32:38
(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 16:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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 16:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978369
Page 227 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-08-2020 16:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978370
Page 228 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 12:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978371
Page 229 of 343
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
2.a
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978372
Page 230 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Sep-28-2020 12:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978373
Page 231 of 343
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-28-2020 12:55:38 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0978374
Page 232 of 343
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-28-2020 12:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0978375
Page 233 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 12:55:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 12:55:52
(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-28-2020 16:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 12:55:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 12:55:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 16:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXTHJInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0978376
Page 234 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 16:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXTHJInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0978377
Page 235 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-28-2020 12:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 12:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 12:56:16
(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-28-2020 12:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020 08:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 12:56:16
(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-28-2020 12:56:16
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0978378
Page 236 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-28-2020 12:56:16
(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-28-2020 12:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-28-2020 12:56:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0978379
Page 237 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 14:40:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978380
Page 238 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 14:40:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 14:40:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 17:21:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 14:40:40
(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.
Oct-28-2020 14:40:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/28/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 17:21:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR84VNInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0978381
Page 239 of 343
***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: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 17:21:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR84VNInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 17:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6C3SInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 17:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS6C3SInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 17:34:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6C3TInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 17:34:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS6C3TInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0978382
Page 240 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020 02:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Closed Response satisfies query
Oct-26-2020 16:14:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Answered Changed data per query
Oct-26-2020 08:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 6: Opened SAE
RECON:AER#2020413365
Hemiplegic migraine(onset
date:20Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-15-2020 16:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Data is correct as is. Micro
biology form is completed
as not applicable so no
issue.
Oct-15-2020 11:53:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Reissued:Opened DM2: Forms have been
unfreezed, please take the
necessary action, Thank
you.
Oct-15-2020 10:26:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Please unfreeze to update
Oct-15-2020 08:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Reissued:Opened DM1: Please verify and
confirm if no data was
collected for COVID test
form, else clarify.
Oct-14-2020 10:15:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Changed data per query
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978383
Page 241 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Oct-14-2020 09:53:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened DM: Kindly review and
complete ‘Covid test form'
at this visit. Thank you.
Oct-14-2020 09:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed requery issued to site
Oct-14-2020 07:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Please advise as no
microbiology specimen is
on this page
Oct-14-2020 03:20:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly review and
complete ‘Microbiology
Specimen form' at this
visit. Thank you.
Oct-09-2020 16:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Oct-09-2020 16:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: 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.
Oct-09-2020 16:04:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-09-2020 16:01:30
(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.
Oct-09-2020 16:01:30
(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
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978384
Page 242 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
as appropriate.
Oct-09-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-09-2020 16:01:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0978385
Page 243 of 343
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-29-2020 10:58:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:
Oct/28/2020Changed
Information
Oct-27-2020 19:07:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Requeried on
COVID B visit.
Oct-26-2020 09:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinquery: Per
protocol 8.1, "if new
symptoms are
reported within 4
days after resolution
of all previous
symptoms, they will
be considered as
part of a single
illness." COVID_B
symptom start date
is 22Oct2020 which
is within 4 days of
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978386
Page 244 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
COVID_A end date.
Oct-26-2020 08:53:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-26-2020 08:53:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:
Oct/19/2020Changed
Information
Oct-26-2020 08:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Page is unfrozen
please update.
Thank you
Oct-26-2020 08:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Clinical Query: DM,
please unfreeze so
site can update.
Oct-26-2020 07:43:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze to
update
Oct-25-2020 10:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Query:
Symptoms in this
visit are still
ongoing, however
COVID_B visit is
conducted. Please
clarify whether the
symptoms are still
ongoing or end date
is available.
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
090177e196ae3edf\Final\Final On: 01-Apr-2021 05:03 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0978387
Page 245 of 343
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1109 Site Name: (1109) Accel Research Sites - Clinical Research Unit
Subject No: 11091448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
4.a Symptoms:
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-09-2020 16:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED 
…[truncated]