Document text
Page 1 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958727
Page 2 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/6/2020
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958728
Page 3 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10831060]
2.Birth Date: /1975
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958729
Page 4 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/6/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958730
Page 5 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958731
Page 6 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958732
Page 7 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis-Seasonal]
Start Date: UNK/UNK/1976
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Umbilical hernia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Partial Achilles Tendon Tear-Right Foot]
Start Date: Mar/UNK/2018
Ongoing: NO
End Date:
Mar/UNK/2018
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hair Loss]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958733
Page 8 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pectoralis Tendon Tear-Right]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Foot Achilles Tendon Repair]
Start Date: Mar/UNK/2018
Ongoing: NO
End Date:
Mar/UNK/2018
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pectoralis tendon Tear Repair-Right]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1 hLine/MH Number: [8] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Stomach Cramps] Comments
Start Date: Aug/3/2020 Comments
Ongoing: YES Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958734
Page 9 of 912
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/6/2020
2.Weight: [180.2]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [27.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958735
Page 10 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/6/2020
2.Randomization Number: [43386]
3.Randomization Group: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958736
Page 11 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/6/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6V56]
5.bSample ID [BP6V57]
5.cSample ID [BP6V58]
5.dSample ID [BG1VL5]
5.eSample ID [BG1VL6]
5 fSample ID [ ]
5.gSample ID [BP6V4H]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958737
Page 12 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/6/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6V4F]
5.bSample ID [BP6V4H]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958738
Page 13 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/6/2020 11:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958739
Page 14 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958740
Page 15 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958741
Page 16 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Aug/13/2020
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Aug/13/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Aug/13/2020
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958742
Page 17 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958743
Page 18 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958744
Page 19 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958745
Page 20 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958746
Page 21 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958747
Page 22 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958748
Page 23 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958749
Page 24 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958750
Page 25 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP21WJ]
5.bSample ID [BPHMT3]
5.cSample ID [BPHMT4]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958751
Page 26 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958752
Page 27 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/4/2020
2.Date of First Symptom Started: Dec/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/17/2020
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? YES
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958753
Page 28 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Runny Nose]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958754
Page 29 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/2/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958755
Page 30 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [SARS-CoV-2 RNA CLIA CERTIFIED LAB]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958756
Page 31 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:[Self Swab not done but performed by PI]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958757
Page 32 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/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 [BKN286]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958758
Page 33 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958759
Page 34 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.Other Type of Practitioner
Specify:[24 Hr Covid Drive Thru Testing]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958760
Page 35 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958761
Page 36 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958762
Page 37 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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]
Date of Diagnosis:
Dec/2/2020
3.Toxicity Grade: 1
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958763
Page 38 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958764
Page 39 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958765
Page 40 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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 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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958766
Page 41 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958767
Page 42 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958768
Page 43 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958769
Page 44 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958770
Page 45 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applica
ble Not Applicable Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958771
Page 46 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958772
Page 47 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958773
Page 48 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958774
Page 49 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958775
Page 50 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958776
Page 51 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958777
Page 52 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Dec/4/2020 Record Identifier: Systolic: Diastolic:
1 142 86 Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958778
Page 53 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [142]
Diastolic: [86]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [69]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958779
Page 54 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958780
Page 55 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958781
Page 56 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958782
Page 57 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958783
Page 58 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958784
Page 59 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958785
Page 60 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958786
Page 61 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958787
Page 62 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958788
Page 63 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958789
Page 64 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4 hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958790
Page 65 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Collec
tionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice Typ
eForm Instanc
e
1.Not Applicabl
e Not Applica
ble Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958791
Page 66 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958792
Page 67 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958793
Page 68 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958794
Page 69 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:Not Applicable Comments
Health Care Utilization Other
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958795
Page 70 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.Other Type of Practitioner
Specify:Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958796
Page 71 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958797
Page 72 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958798
Page 73 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958799
Page 74 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958800
Page 75 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958801
Page 76 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#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 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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958802
Page 77 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958803
Page 78 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958804
Page 79 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958805
Page 80 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958806
Page 81 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applica
ble Not Applicable Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable
Not Applicable Not App
licable Not App
licable Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958807
Page 82 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958808
Page 83 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958809
Page 84 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958810
Page 85 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958811
Page 86 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958812
Page 87 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958813
Page 88 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
1 Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958814
Page 89 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958815
Page 90 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958816
Page 91 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958817
Page 92 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958818
Page 93 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958819
Page 94 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958820
Page 95 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958821
Page 96 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958822
Page 97 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Dec/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958823
Page 98 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958824
Page 99 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/05/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCJ9L]
5.bSample ID [BM3M47]
5.cSample ID [BM3M48]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958825
Page 100 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/07/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958826
Page 101 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/07/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958827
Page 102 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/07/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/7/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958828
Page 103 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/08/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/8/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958829
Page 104 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/08/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958830
Page 105 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/08/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/8/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958831
Page 106 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Aug/11/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958832
Page 107 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Aug/11/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958833
Page 108 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Aug/11/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/11/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958834
Page 109 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Aug/12/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958835
Page 110 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Aug/12/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958836
Page 111 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 4 - Unscheduled Visit on
Aug/12/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/12/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958837
Page 112 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Aug/13/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958838
Page 113 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Aug/13/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958839
Page 114 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 5 - Unscheduled Visit on
Aug/13/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/13/2020
Contact Outcome:
VISIT ARRANGED, BUT NOT ATTENDED
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958840
Page 115 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Aug/14/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958841
Page 116 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Aug/14/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958842
Page 117 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 6 - Unscheduled Visit on
Aug/14/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/14/2020
Contact Outcome:
VISIT NOT ARRANGED, UNABLE TO ATTEND
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958843
Page 118 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Aug/15/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958844
Page 119 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Aug/15/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958845
Page 120 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned 7 - Unscheduled Visit on
Aug/15/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/15/2020
Contact Outcome:
VISIT NOT ARRANGED, UNABLE TO ATTEND
3.Comments: [Site has been in contact with this subject. Uns visits were offered and
subject declined]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958846
Page 121 of 912
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Aug/14/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958847
Page 122 of 912
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958848
Page 123 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Dec/11/2020Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: COVID_BR1
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958849
Page 124 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/11/2020
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 [BRCJ7H]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958850
Page 125 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Worsening of Abdo
minal Pain Aug/14/2020 00:
00 NO
End Date Time:
Aug/24/2020 11:32
Repeating
Pages
2.ADVERSE E
VENT 2 Post Operative Ileus
Aug/18/2020 00:
00 NO
End Date Time:
Aug/23/2020 00:00
Repeating
Pages
3.ADVERSE E
VENT 3 Ruptured diverticulu
m Aug/14/2020 00:
00 NO
End Date Time:
Aug/24/2020 00:00
Repeating
Pages
4.ADVERSE E
VENT 4 Phlegmon Formatio
n Aug/20/2020 00:
00 NO
End Date Time:
Aug/20/2020 00:00
Repeating
Pages
5.ADVERSE E
VENT 5 Diverticulitis Aug/20/2020 00:
00 NO
End Date Time:
Aug/25/2020 UNK:U
NK
Repeating
Pages
6.ADVERSE E
VENT 6 Small Bowel Obstru
ction Aug/20/2020 00:
00 NO
End Date Time:
Aug/20/2020 00:00
Repeating
Pages
7.ADVERSE E
VENT 7 Diverticulitis Aug/26/2020 UN
K:UNK YES Repeating
Pages
8.ADVERSE E
VENT 8 Fatigue Mar/7/2021 00:0
0 NO
End Date Time:Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958851
Page 126 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
Mar/8/2021 00:00
9.ADVERSE E
VENT 9 Slight Headache Mar/7/2021 00:0
0 NO
End Date Time:
Mar/8/2021 00:00
Repeating
Pages
10.ADVERSE E
VENT 10 Injection Site Pain-
Left Mar/7/2021 00:0
0 NO
End Date Time:
Mar/8/2021 00:00
Repeating
Pages
11.ADVERSE E
VENT 11 Muscle Aches Mar/7/2021 00:0
0 NO
End Date Time:
Mar/8/2021 00:00
Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958852
Page 127 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Worsening of Abdominal Pain]
4.Start Date Time: Aug/14/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/24/2020 11:32
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).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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958853
Page 128 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Ruptured Diverticulum]
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958854
Page 129 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Post Operative Ileus]
4.Start Date Time: Aug/18/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/23/2020 00:00
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958855
Page 130 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Surgical Side Effect]
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958856
Page 131 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Ruptured diverticulum]
4.Start Date Time: Aug/14/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/24/2020 00:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
YES
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958857
Page 132 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Infection]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020319554]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958858
Page 133 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Phlegmon Formation]
4.Start Date Time: Aug/20/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/20/2020 00:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958859
Page 134 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Diverticulitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958860
Page 135 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Diverticulitis]
4.Start Date Time: Aug/20/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/25/2020 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).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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958861
Page 136 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[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?: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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958862
Page 137 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Small Bowel Obstruction]
4.Start Date Time: Aug/20/2020 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/20/2020 00:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958863
Page 138 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Ruptured Diverticulum]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958864
Page 139 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Diverticulitis]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958865
Page 140 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Medical event]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958866
Page 141 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Fatigue]
4.Start Date Time: Mar/7/2021 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/8/2021 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958867
Page 142 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958868
Page 143 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Slight Headache]
4.Start Date Time: Mar/7/2021 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/8/2021 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958869
Page 144 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958870
Page 145 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection Site Pain-Left]
4.Start Date Time: Mar/7/2021 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/8/2021 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958871
Page 146 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958872
Page 147 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle Aches]
4.Start Date Time: Mar/7/2021 00:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/8/2021 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958873
Page 148 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958874
Page 149 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryMedication
ErrorStart DateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
1.Not Applic
able Not Applicab
le Not Applic
able Not Applicable Not Applicable Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958875
Page 150 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment
given?Not Applicable Comments
8.Did the Medication Error cause
the subject to be discontinued
from the study?Not Applicable Comments
9.Was this medication error
associated with any adverse
events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958876
Page 151 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1.1 VACCINATION
S NO Influenza Vacc
ine Feb/2/2
021 Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958877
Page 152 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1] Comments
2.Category: VACCINATIONS Comments
3.Concomitant Medications
Pre-specified:NO Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Influenza Vaccine] Comments
5.Date: Feb/2/2021 Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958878
Page 153 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicabl
e Not Applic
able Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958879
Page 154 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958880
Page 155 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Start DateForm Instanc
e
1.Not Applica
ble Not Applicable Not Applicable Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958881
Page 156 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958882
Page 157 of 912
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958883
Page 158 of 912
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958884
Page 159 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958885
Page 160 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958886
Page 161 of 912
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958887
Page 162 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958888
Page 163 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958889
Page 164 of 912
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958890
Page 165 of 912
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958891
Page 166 of 912
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958892
Page 167 of 912
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958893
Page 168 of 912
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958894
Page 169 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958895
Page 170 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/6/2021
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958896
Page 171 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958897
Page 172 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/6/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958898
Page 173 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM2L3V]
5.bSample ID [BKN1XT]
5.cSample ID [BKN1YC ]
5.dSample ID [BM2L4C]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958899
Page 174 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKN1YC]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958900
Page 175 of 912
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/6/2021 11:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958901
Page 176 of 912
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958902
Page 177 of 912
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958903
Page 178 of 912
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958904
Page 179 of 912
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958905
Page 180 of 912
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958906
Page 181 of 912
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958907
Page 182 of 912
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958908
Page 183 of 912
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958909
Page 184 of 912
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958910
Page 185 of 912
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958911
Page 186 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/14/2020
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958912
Page 187 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958913
Page 188 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958914
Page 189 of 912
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-07-2020 14:03:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormAug-07-2020 14:02:29 (UTC-06:00) Central
Time (US & Canada)
FormAug-06-2020 18:12:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormAug-06-2020 17:58:07 (UTC-06:00) Central
Time (US & Canada)
FormAug-06-2020 17:57:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormAug-06-2020 17:56:21 (UTC-06:00) Central
Time (US & Canada)
FormAug-06-2020 17:55:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958915
Page 190 of 912
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.hAug-19-2020 18:06:00 (UTC-06:00) Central
Time (US & Canada)Site added a late entry to medical history as
subject did not disclose this information
during medical history review
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958916
Page 191 of 912
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.hAug-19-2020 18:06:00 (UTC-06:00) Central
Time (US & Canada)Site added a late entry to medical history as
subject did not disclose this information
during medical history review
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958917
Page 192 of 912
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.hAug-19-2020 18:06:00 (UTC-06:00) Central
Time (US & Canada)Site added a late entry to medical history as
subject did not disclose this information
during medical history review
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958918
Page 193 of 912
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.hAug-19-2020 18:06:00 (UTC-06:00) Central
Time (US & Canada)Site added a late entry to medical history as
subject did not disclose this information
during medical history review
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958919
Page 194 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-23-2020 15:08:08 (UTC-06:00) Central
Time (US & Canada)15SEP2020 PI decision to not do V2 due to
SAE and unstable medical conditions.
Subject did not discontinue and will be
followed up for safety and data collection
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958920
Page 195 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-23-2020 15:08:08 (UTC-06:00) Central
Time (US & Canada)15SEP2020 PI decision to not do V2 due to
SAE and unstable medical conditions. Subject
did not discontinue and will be followed up
for safety and data collection
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958921
Page 196 of 912
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Oct-23-2020 15:08:08 (UTC-06:00) Central
Time (US & Canada)15SEP2020 PI decision to not do V2 due to
SAE and unstable medical conditions. Subject
did not discontinue and will be followed up
for safety and data collection
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958922
Page 197 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958923
Page 198 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958924
Page 199 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958925
Page 200 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.bOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958926
Page 201 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.cOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958927
Page 202 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.dOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958928
Page 203 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.eOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958929
Page 204 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.fOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958930
Page 205 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.gOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958931
Page 206 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.hOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958932
Page 207 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Oct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958933
Page 208 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Oct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958934
Page 209 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958935
Page 210 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958936
Page 211 of 912
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cOct-22-2020 15:07:29 (UTC-06:00) Central
Time (US & Canada)PI decision due to SAE and unstable medical
conditions subject did not get V2
eDiary not applicable
Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958937
Page 212 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormDec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958938
Page 213 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958939
Page 214 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958940
Page 215 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958941
Page 216 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958942
Page 217 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958943
Page 218 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Dec-04-2020 16:57:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958944
Page 219 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormDec-04-2020 17:14:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958945
Page 220 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Dec-04-2020 17:14:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958946
Page 221 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Dec-04-2020 17:14:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958947
Page 222 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Dec-04-2020 17:14:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958948
Page 223 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Dec-04-2020 17:14:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958949
Page 224 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958950
Page 225 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
5.bDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
5.bDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
5.bDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
5.bDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
5.cDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
5.cDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
5.cDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
5.cDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
5.dDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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ItemDate User Comment
5.eDec-04-2020 17:11:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Subject No: 10831060 Subject Initials: ---
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Subject No: 10831060 Subject Initials: ---
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Subject No: 10831060 Subject Initials: ---
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Subject No: 10831060 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
FormDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958983
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
1Dec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958984
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
2Dec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958985
Page 260 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Dec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958986
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Dec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958987
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958988
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958993
Page 268 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958994
Page 269 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958996
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958997
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958998
Page 273 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958999
Page 274 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dDec-04-2020 17:11:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f94\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0959000
Page 275 of 912
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831060 Subject Initials: ---
…[truncated]