Document text
Page 1 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968986
Page 2 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968987
Page 3 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10941112]
2.Birth Date: /1963
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968988
Page 4 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968989
Page 5 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968990
Page 6 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968991
Page 7 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Type II]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: May/26/2020
Ongoing: YES
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968992
Page 8 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroid]
Start Date: UNK/UNK/2005
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: May/26/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968993
Page 9 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [79.5]
3.Unit: kg
4.Height: [152.4]
5.Unit: cm
6.Body Mass Index: [34.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968994
Page 10 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968995
Page 11 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [254660]
3.Randomization Group: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968996
Page 12 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [BN6C31]
5.bSample ID [BN6C32]
5.cSample ID [BN6C33]
5.dSample ID [BL9Y3X]
5.eSample ID [BL9Y3W]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968997
Page 13 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [BJGX7X]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968998
Page 14 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 14:59
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968999
Page 15 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969000
Page 16 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969001
Page 17 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969002
Page 18 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969003
Page 19 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BN6C7D]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969004
Page 20 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/29/2020 14:25
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969005
Page 21 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969006
Page 22 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [BP1M4K]
5.bSample ID [BP1M4L]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969007
Page 23 of 931
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969008
Page 24 of 931
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969009
Page 25 of 931
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969010
Page 26 of 931
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969011
Page 27 of 931
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969012
Page 28 of 931
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969013
Page 29 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969014
Page 30 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/7/2020
2.Date of First Symptom Started: Sep/30/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/5/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969015
Page 31 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
5.bSymptoms - Other Text: [joint pain]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969016
Page 32 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Collec
tionSpecimen T
ypeSpecimen Collection Lo
cationAssay Code and Descr
iptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969017
Page 33 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969018
Page 34 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[collected in clinic visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV17292]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969019
Page 35 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[not required as self swab was used] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969020
Page 36 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969021
Page 37 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969022
Page 38 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969023
Page 39 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969024
Page 40 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969025
Page 41 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969026
Page 42 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?NO
3.Toxicity Grade: 1
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969027
Page 43 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969028
Page 44 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969029
Page 45 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Appli
cable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969030
Page 46 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969031
Page 47 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969032
Page 48 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969033
Page 49 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969034
Page 50 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969035
Page 51 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969036
Page 52 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969037
Page 53 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969038
Page 54 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969039
Page 55 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969040
Page 56 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969041
Page 57 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969042
Page 58 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969043
Page 59 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969044
Page 60 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969045
Page 61 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969046
Page 62 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969047
Page 63 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969048
Page 64 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969049
Page 65 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969050
Page 66 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969051
Page 67 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969052
Page 68 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/16/2020
2.Date of First Symptom Started: Oct/13/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969053
Page 69 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [body ache]
5.bSymptoms - Other Text: [fever blister]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969054
Page 70 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/16/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969055
Page 71 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/16/2020 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: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [CLIA-certified lab #45D2074140] Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969056
Page 72 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[collected in clinic]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969057
Page 73 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BP1M1R]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969058
Page 74 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969059
Page 75 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969060
Page 76 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969061
Page 77 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969062
Page 78 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969063
Page 79 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969064
Page 80 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?NO
3.Toxicity Grade: 1
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969065
Page 81 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969066
Page 82 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969067
Page 83 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969068
Page 84 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969069
Page 85 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969070
Page 86 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969071
Page 87 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969072
Page 88 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY LabCorp Houston, 7207 Nort
h Gessner, Houston, TX 7704
03143 Oct/16/
2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglob
in_PX1 12.
2
2 Hematocri
t_PX2 36.
3
3 Erythrocyt
es_PX3 [ ]
5 Platelets_
PX5 357
7 Leukocyte
s_PX7 9.8
608 Neutrophi
ls_PX608 5.4
609 Eosinophi
ls_PX609 0.3
612 Monocyte
s_PX612 0.8
610 Basophils
_PX610 0.1
611 Lymphocy
tes_PX61
1 3.2 Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969073
Page 89 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [LabCorp Houston, 7207 North Gessner, Houston, TX 770403143]
3.Collection Date: Oct/16/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.2]
Not Done:
LNMT Low
[11.1]
High
[15.9]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.3]
Not Done:
LNMT Low
[34.0]
High
[46.6]
Unit
%
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969074
Page 90 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [357]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [9.8]
Not Done:
LNMT Low
[3.4]
High
[10.8]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969075
Page 91 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [5.4]
Not Done:
LNMT Low
[1.4]
High
[7.0]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[0.40]
Unit
10^3/uL
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.8]
Not Done:
LNMT Low
[0.1]
High
[0.9]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969076
Page 92 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^3/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [3.2]
Not Done:
LNMT Low
[0.7]
High
[3.1]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969077
Page 93 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
1 Not Done Not Done Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969078
Page 94 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969079
Page 95 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969080
Page 96 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969081
Page 97 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969082
Page 98 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969083
Page 99 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969084
Page 100 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969085
Page 101 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969086
Page 102 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Oct/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969087
Page 103 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969088
Page 104 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/18/2020
2.Date of First Symptom Started: Nov/26/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969089
Page 105 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [pneumonia]
5.bSymptoms - Other Text: [Acute hypoxemic respiratory failure]
5.cSymptoms - Other Text: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969090
Page 106 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/26/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969091
Page 107 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/26/2020 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: [TMC Lab, Memorial Hermann Hospital 6411 Fannin, Houston,
TX, 77030-]Comments
9.Trade Name Other, Specify: [CLIA Certified Lab] Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969092
Page 108 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[not done]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969093
Page 109 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[not collected as patient was hospitalized]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969094
Page 110 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969095
Page 111 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969096
Page 112 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Nov/26/2020 NO
Discharge Date:
Dec/18/2020
Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969097
Page 113 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/26/2020
4.Ongoing? NO
Discharge Date:
Dec/18/2020
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969098
Page 114 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969099
Page 115 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969100
Page 116 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 related pneumonia]
Date of Diagnosis:
Nov/26/2020
3.Toxicity Grade: 4
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969101
Page 117 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969102
Page 118 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969103
Page 119 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men
TypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY PL Lab, Memorial Hermann Pearlan
d Hospital, 16100 South Freeway, P
earland, TX, 77584- , (713) 413-565
2 Nov/2
6/202
0 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive
Protein_PX
329 [ ]
30 Alanine Am
inotransfera
se_PX30 35
28 Aspartate A
minotransfe
rase_PX28 19
35 Alkaline Ph
osphatase_P
X35 91
21 Bilirubin_P
X21 0.3
47 Blood Urea
Nitrogen_P
X47 16
48 Creatinine_
PX48 0.7
6 Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969104
Page 120 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men
TypeLab ResultForm Insta
nce
2.CLINICA
L CHEMI
STRY PL Lab, Memorial Hermann Pearlan
d Hospital, 16100 South Freeway, P
earland, TX, 77584- , (713) 413-565
2 Dec/1
6/202
0 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive
Protein_PX
329 [ ]
30 Alanine Am
inotransfera
se_PX30 33
28 Aspartate A
minotransfe
rase_PX28 48
35 Alkaline Ph
osphatase_P
X35 12
4
21 Bilirubin_P
X21 0.3
47 Blood Urea
Nitrogen_P
X47 10
9
48 Creatinine_
PX48 4.6
1 Repeating
Pages
3.CLINICA
L CHEMI
STRY PL Lab, Memorial Hermann Pearlan
d Hospital, 16100 South Freeway, P
earland, TX, 77584- , (713) 413-565
2 Dec/1
4/202
0 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive
Protein_PX
329 [ ]
30 Alanine Am
inotransfera
se_PX30 38
28 Aspartate A
minotransfe
rase_PX28 32 Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969105
Page 121 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men
TypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
35 Alkaline Ph
osphatase_P
X35 14
5
21 Bilirubin_P
X21 0.3
47 Blood Urea
Nitrogen_P
X47 73
48 Creatinine_
PX48 2.4
3
4.CLINICA
L CHEMI
STRY PL Lab, Memorial Hermann Pearlan
d Hospital, 16100 South Freeway, P
earland, TX, 77584- , (713) 413-565
2 Dec/1
5/202
0 BLO
OD Sponsor-
Defined I
dentifierTest:Re
sul
t:
329 C Reactive
Protein_PX
329 [ ]
30 Alanine Am
inotransfera
se_PX30 33
28 Aspartate A
minotransfe
rase_PX28 40
35 Alkaline Ph
osphatase_P
X35 13
0
21 Bilirubin_P
X21 0.3
47 Blood Urea
Nitrogen_P
X47 97 Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969106
Page 122 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Category
for Lab T
estVendor NameCollec
tion D
ate:Speci
men
TypeLab ResultForm Insta
nce
Sponsor-
Defined I
dentifierTest:Re
sul
t:
48 Creatinine_
PX48 3.7
2
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969107
Page 123 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Nov/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [35]
Not Done:
LNMT Low
[0]
High
[65]
Unit
U/L
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969108
Page 124 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [19]
Not Done:
LNMT Low
[0]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [91]
Not Done:
LNMT Low
[39]
High
[136]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969109
Page 125 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [16]
Not Done:
LNMT Low
[7]
High
[22]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.76]
Not Done:
LNMT Low
[0.5]
High
[1.4]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969110
Page 126 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Dec/16/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [33]
Not Done:
LNMT Low
[0]
High
[65]
Unit
U/L
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969111
Page 127 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [48]
Not Done:
LNMT Low
[0]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [124]
Not Done:
LNMT Low
[39]
High
[136]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
U/L
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969112
Page 128 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [109]
Not Done:
LNMT Low
[7]
High
[22]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [4.61]
Not Done:
LNMT Low
[0.5]
High
[1.4]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969113
Page 129 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Dec/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [38]
Not Done:
LNMT Low
[0]
High
[65]
Unit
U/L
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969114
Page 130 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [32]
Not Done:
LNMT Low
[0]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [145]
Not Done:
LNMT Low
[39]
High
[136]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969115
Page 131 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [73]
Not Done:
LNMT Low
[7]
High
[22]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [2.43]
Not Done:
LNMT Low
[0.5]
High
[1.4]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969116
Page 132 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Dec/15/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [33]
Not Done:
LNMT Low
[0]
High
[65]
Unit
U/L
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969117
Page 133 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [40]
Not Done:
LNMT Low
[0]
High
[37]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [130]
Not Done:
LNMT Low
[39]
High
[136]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.3]
Not Done:
LNMT Low
[0.2]
High
[1.3]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969118
Page 134 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 14-Jan-2021 02:30 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [97]
Not Done:
LNMT Low
[7]
High
[22]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [3.72]
Not Done:
LNMT Low
[0.5]
High
[1.4]
Unit
mg/dL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969119
Page 135 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
y for La
b TestVendor Name (DERIVED)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
1.HEMAT
OLOGY PL Lab, Memorial Hermann Pearland
Hospital, 16100 South Freeway, Pearla
nd, TX, 77584- , (713) 413-5652 Nov/2
6/2020
BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
1 Hemogl
obin_PX
1 12.
5
2 Hemato
crit_PX
2 36.
8
3 Erythroc
ytes_PX
3 4.2
6
5 Platelets
_PX5 260
7 Leukocy
tes_PX7
8.9
608 Neutrop
hils_PX
608 8
609 Eosinop
hils_PX
609 [ ]
612 Monocy
tes_PX6
12 0.4
610 Basophil
s_PX61
0 0.1
611 Lympho
cytes_P
X611 0.5 Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969120
Page 136 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
y for La
b TestVendor Name (DERIVED)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
2.HEMAT
OLOGY PL Lab, Memorial Hermann Pearland
Hospital, 16100 South Freeway, Pearla
nd, TX, 77584- , (713) 413-5652 Dec/1
3/2020
BLOO
D Sponsor-
Defined I
dentifierTest:Re
sul
t:
1 Hemogl
obin_PX
1 8.8
2 Hemato
crit_PX
2 28.
7
3 Erythroc
ytes_PX
3 3.0
7
5 Platelets
_PX5 177
7 Leukocy
tes_PX7
18
608 Neutrop
hils_PX
608 17.
6
609 Eosinop
hils_PX
609 [ ]
612 Monocy
tes_PX6
12 0.2
610 Basophil
s_PX61
0 [ ]
611 Lympho
cytes_P
X611 0.2 Repeating
Pages
3.HEMAT
OLOGY PL Lab, Memorial Hermann Pearland
Hospital, 16100 South Freeway, PearlaDec/1
4/2020BLOO
D Sponsor-
Defined ITest:Re
sulRepeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969121
Page 137 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
y for La
b TestVendor Name (DERIVED)Collec
tion D
ate:Speci
men T
ypeLab ResultForm Insta
nce
nd, TX, 77584- , (713) 413-5652 dentifier t:
1 Hemogl
obin_PX
1 8.4
2 Hemato
crit_PX
2 26.
7
3 Erythroc
ytes_PX
3 13.
6
5 Platelets
_PX5 163
7 Leukocy
tes_PX7
13.
6
608 Neutrop
hils_PX
608 13.
1
609 Eosinop
hils_PX
609 [ ]
612 Monocy
tes_PX6
12 0.2
610 Basophil
s_PX61
0 [ ]
611 Lympho
cytes_P
X611 0.3
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969122
Page 138 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Nov/26/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.5]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.8]
Not Done:
LNMT Low
[36]
High
[48]
Unit
%
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969123
Page 139 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.26]
Not Done:
LNMT Low
[4.2]
High
[5.4]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [260]
Not Done:
LNMT Low
[133]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [8.9]
Not Done:
LNMT Low
[3.7]
High
[10.4]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969124
Page 140 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [8]
Not Done:
LNMT Low
[1.5]
High
[8.1]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.4]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969125
Page 141 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.1]
Not Done:
LNMT Low
[0.0]
High
[1.0]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.5]
Not Done:
LNMT Low
[1.0]
High
[5.5]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969126
Page 142 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Dec/13/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.8]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [28.7]
Not Done:
LNMT Low
[36]
High
[48]
Unit
%
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969127
Page 143 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [3.07]
Not Done:
LNMT Low
[4.2]
High
[5.4]
Unit
10^6/cu mm
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [177]
Not Done:
LNMT Low
[133]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [18]
Not Done:
LNMT Low
[3.7]
High
[10.4]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969128
Page 144 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [17.6]
Not Done:
LNMT Low
[1.5]
High
[8.1]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969129
Page 145 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.2]
Not Done:
LNMT Low
[1.0]
High
[5.5]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969130
Page 146 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [PL Lab, Memorial Hermann Pearland Hospital, 16100 South Freeway,
Pearland, TX, 77584- , (713) 413-5652]
3.Collection Date: Dec/14/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [8.4]
Not Done:
LNMT Low
[12]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [26.7]
Not Done:
LNMT Low
[36]
High
[48]
Unit
%
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969131
Page 147 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [13.6]
Not Done:
LNMT Low
[3.7]
High
[10.4]
Unit
10^3/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [163]
Not Done:
LNMT Low
[133]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [13.6]
Not Done:
LNMT Low
[3.7]
High
[10.4]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969132
Page 148 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [13.1]
Not Done:
LNMT Low
[1.5]
High
[8.1]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.2]
Not Done:
LNMT Low
[0.0]
High
[0.8]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969133
Page 149 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.3]
Not Done:
LNMT Low
[1.0]
High
[5.5]
Unit
10^3/uL
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969134
Page 150 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Nov/26/2020 Record Identifier: Systolic: Diastolic:
1 125 66 Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969135
Page 151 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
2.Nov/28/2020 Record Identifier: Systolic: Diastolic:
1 96 62 Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969136
Page 152 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125]
Diastolic: [66]
Respiratory Rate in
respirations/minute:[44]
Heart Rate in beats/minute: [91]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969137
Page 153 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [96]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[25]
Heart Rate in beats/minute: [57]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969138
Page 154 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
1.Dec/16/2020 Record Identifier: Oxygen Saturation
1 83.3 Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969139
Page 155 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Date: Vital Signs Details Form Instance
2.Dec/12/2020 Record Identifier: Oxygen Saturation
1 93.9 Repeating Pages
3.Dec/9/2020 Record Identifier: Oxygen Saturation
1 98.4 Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969140
Page 156 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/16/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [83.3]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969141
Page 157 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/12/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.9]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969142
Page 158 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/9/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.4]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969143
Page 159 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
1.Dec/16/2020 05:16 68 1.00 Repeating Pages
2.Dec/12/2020 05:26 84 1.00 Repeating Pages
3.Dec/9/2020 08:14 125 0.75 Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969144
Page 160 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Dec/16/2020 05:16
2.Arterial Blood Gases PaO2
(mmHg):[68]
3.FiO2 (Fraction of Inhaled
Oxygen):[1.00]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969145
Page 161 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Dec/12/2020 05:26
2.Arterial Blood Gases PaO2
(mmHg):[84]
3.FiO2 (Fraction of Inhaled
Oxygen):[1.00]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969146
Page 162 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Dec/9/2020 08:14
2.Arterial Blood Gases PaO2
(mmHg):[125]
3.FiO2 (Fraction of Inhaled
Oxygen):[0.75]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969147
Page 163 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969148
Page 164 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969149
Page 165 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Date of A
ssessmentLocation of
AssessmentImaging
MethodOverall AssessmentForm Insta
nce
1.Nov/26/2
020 OTHER
If other, spe
cify:
Abdomen
w/pelvis
CT SCA
N ABNORMAL
If abnormal, specify findings:
Extensive ground glass pulmonary opacities in the visua
lize lungs consistent with the given history of covid-19 i
nfection
Repeating
Pages
2.Dec/1/202
0 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
mildly improved opacities in the lower lobes; no definit
e pneumothorax
Repeating
Pages
3.Dec/2/202
0 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
resolution of the right pneumothorax and decrease in siz
e of the trace left apical pneumothorax
Repeating
Pages
4.Nov/26/2
020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
bilateral pneumonia
Repeating
Pages
5.Nov/30/2
020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
severe viral pneumonia
Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969150
Page 166 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/26/2020
2.Location of Assessment: OTHER
If other, specify:
[Abdomen w/pelvis]
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Extensive ground glass pulmonary opacities in the visualize lungs
consistent with the given history of covid-19 infection]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969151
Page 167 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/1/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[mildly improved opacities in the lower lobes; no definite pneumothorax]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969152
Page 168 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/2/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[resolution of the right pneumothorax and decrease in size of the trace left
apical pneumothorax]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969153
Page 169 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/26/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[bilateral pneumonia]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969154
Page 170 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled
Visit on Dec/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/30/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[severe viral pneumonia]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969155
Page 171 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969156
Page 172 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BP1M7C]
5.bSample ID [BP1M7D]
5.cSample ID [BKBHS2]
5.dSample ID [BKBHS3]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969157
Page 173 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/17/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969158
Page 174 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
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 [BP1LKY]
5.bSample ID [BP1LKZ]
5.cSample ID [ ]
5.dSample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969159
Page 175 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969160
Page 176 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969161
Page 177 of 931
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969162
Page 178 of 931
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969163
Page 179 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969164
Page 180 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969165
Page 181 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. DELETED ADVERSE
EVENT 1 Fever Oct/2/2020 U
NK:UNK NO
End Date Time:
Oct/4/2020 UNK:
UNK
Repeating
Pages
2. DELETED ADVERSE
EVENT 2 joint pain Sep/30/2020
UNK:UNK NO
End Date Time:
Oct/4/2020 UNK:
UNK
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 fatigue Oct/2/2020 U
NK:UNK NO
End Date Time:
Oct/5/2020 UNK:
UNK
Repeating
Pages
4. DELETED ADVERSE
EVENT 4 shortness of breath Sep/30/2020
UNK:UNK NO
End Date Time:
Oct/4/2020 UNK:
UNK
Repeating
Pages
5. DELETED ADVERSE
EVENT 5 diarrhea Sep/30/2020
UNK:UNK NO
End Date Time:
Oct/3/2020 UNK:
UNK
Repeating
Pages
6. DELETED ADVERSE
EVENT 6 loss of taste and sme
ll Oct/1/2020 U
NK:UNK NO
End Date Time:
Oct/4/2020 UNK:
UNK
Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969166
Page 182 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
7. ADVERSE
EVENT 7 Pneumonia Nov/26/2020
UNK:UNK NO
End Date Time:
Dec/18/2020 UNK
:UNK
Repeating
Pages
8. ADVERSE
EVENT 8 COVID-19 Infectio
n Nov/26/2020
UNK:UNK NO
End Date Time:
Dec/18/2020 UNK
:UNK
Repeating
Pages
9. ADVERSE
EVENT 9 Acute hypoxemic re
spiratory failure Nov/28/2020
UNK:UNK NO
End Date Time:
Dec/18/2020 UNK
:UNK
Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969167
Page 183 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Fever]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969168
Page 184 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969169
Page 185 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[joint pain ]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969170
Page 186 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969171
Page 187 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fatigue]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969172
Page 188 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969173
Page 189 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[shortness of breath ]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969174
Page 190 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969175
Page 191 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[diarrhea]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969176
Page 192 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969177
Page 193 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[loss of taste and smell ]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969178
Page 194 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[covid-19 infection ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969179
Page 195 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pneumonia]
4.Start Date Time: Nov/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 UNK:UNK
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?
YES
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969180
Page 196 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[COVID-19 Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020506662]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969181
Page 197 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[COVID-19 Infection]
4.Start Date Time: Nov/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 UNK:UNK
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?
YES
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969182
Page 198 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[COVID-19]
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?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020506662]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969183
Page 199 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute hypoxemic respiratory failure]
4.Start Date Time: Nov/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 UNK:UNK
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?
YES
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969184
Page 200 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[COVID-19 Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020506662]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969185
Page 201 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969186
Page 202 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969187
Page 203 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969188
Page 204 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: //
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969189
Page 205 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969190
Page 206 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969191
Page 207 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969192
Page 208 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969193
Page 209 of 931
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969194
Page 210 of 931
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969195
Page 211 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969196
Page 212 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969197
Page 213 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969198
Page 214 of 931
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969199
Page 215 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969200
Page 216 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969201
Page 217 of 931
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969202
Page 218 of 931
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969203
Page 219 of 931
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969204
Page 220 of 931
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969205
Page 221 of 931
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969206
Page 222 of 931
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969207
Page 223 of 931
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969208
Page 224 of 931
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969209
Page 225 of 931
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification
of Death:Dec/21/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [COVID-19 Infection]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [Pneumonia]
2.cCause of Death Status:
Cause of Death: [ ]
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969210
Page 226 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/18/2020
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969211
Page 227 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969212
Page 228 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0969213
Page 229 of 931
***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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-09-2020 11:02:51 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969214
Page 230 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969215
Page 231 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969216
Page 232 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969217
Page 233 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969218
Page 234 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969219
Page 235 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969220
Page 236 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969221
Page 237 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969222
Page 238 of 931
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-09-2020 11:04:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969223
Page 239 of 931
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969224
Page 240 of 931
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969225
Page 241 of 931
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969226
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Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969227
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969228
Page 244 of 931
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969229
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969230
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969231
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***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-30-2020 14:03:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969232
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
FormOct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969233
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
1Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969234
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
2Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969235
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
3Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969236
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
4Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969237
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
5Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969238
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
6Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969239
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
7Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
7Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969240
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
8Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
8Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969241
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
9Oct-20-2020 01:23:23 (UTC-06:00) Central
Time (US & Canada)Not Done
9Oct-15-2020 17:10:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969242
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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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-15-2020 17:27:37 (UTC-06:00) Central
Time (US & Canada)
3Oct-15-2020 17:27:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
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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: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-15-2020 17:28:02 (UTC-06:00) Central
Time (US & Canada)
4Oct-15-2020 17:27:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969244
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormFeb-06-2021 01:35:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969245
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Feb-06-2021 01:35:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969246
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Feb-06-2021 01:35:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969247
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Feb-06-2021 01:35:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969248
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Feb-06-2021 01:35:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969249
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormOct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969250
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969251
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969252
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969253
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969254
Page 270 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae30c9\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0969255
Page 271 of 931
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1094 Site Name: (1094) LinQ Research, LLC
Subject No: 10941112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6Oct-15-2020 17:29:36 (UTC-06:00) Central
Time (US & Canada)Not Appli
…[truncated]