Document text
Page 1 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831590
Page 2 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831591
Page 3 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511060]
2.Birth Date: /1987
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831592
Page 4 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831593
Page 5 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831594
Page 6 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831595
Page 7 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid Reflux]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[sinus headaches]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831596
Page 8 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831597
Page 9 of 721
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [347.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [51.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831598
Page 10 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [68849]
3.Randomization Group: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831599
Page 11 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPYNG8]
5.bSample ID [BPYNG9]
5.cSample ID [BPYNGB]
5.dSample ID [BNWBSN]
5.eSample ID [BNWBSP]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831600
Page 12 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPYNVC]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831601
Page 13 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/26/2020 15:30
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831602
Page 14 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831603
Page 15 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831604
Page 16 of 721
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831605
Page 17 of 721
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM907K]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831606
Page 18 of 721
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 08:34
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831607
Page 19 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831608
Page 20 of 721
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BR90PX]
5.bSample ID [BR90PY]
5.cSample ID [BR90PZ]
5.dSample ID [BNWBNN]
5.eSample ID [BNWBNP]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831609
Page 21 of 721
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831610
Page 22 of 721
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
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 [BR4P2P]
5.bSample ID [BR4P2R]
5.cSample ID [BR4P2S]
5.dSample ID [BNVKRW]
5.eSample ID [BNVKRX]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831611
Page 23 of 721
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831612
Page 24 of 721
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831613
Page 25 of 721
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831614
Page 26 of 721
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831615
Page 27 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831616
Page 28 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom
Started:Oct/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831617
Page 29 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831618
Page 30 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831619
Page 31 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831620
Page 32 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
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 [CV29620]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831621
Page 33 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[sample collected by subject. not in our office]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831622
Page 34 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831623
Page 35 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831624
Page 36 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831625
Page 37 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831626
Page 38 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831627
Page 39 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831628
Page 40 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831629
Page 41 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Tes
tVendor
NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.Not Applic
able Not Ap
plicable
Not App
licable Not Ap
plicable
Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Not Applica
ble Not Ap
plicable
Not Ap
plicable
Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831630
Page 42 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831631
Page 43 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831632
Page 44 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831633
Page 45 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831634
Page 46 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831635
Page 47 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831636
Page 48 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831637
Page 49 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
1.Not Appli
cable Not Applica
ble Not Ap
plicable
Not Ap
plicabl
e Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831638
Page 50 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category
for Lab T
estVendor Na
me (DERIV
ED)Collect
ion Dat
e:Speci
men T
ypeLab ResultForm Insta
nce
Sponsor-De
fined Identi
fierTest:Result
:
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
Not Applica
ble Not Ap
plicabl
e Not Ap
plicabl
e
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831639
Page 51 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831640
Page 52 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831641
Page 53 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831642
Page 54 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831643
Page 55 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831644
Page 56 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831645
Page 57 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831646
Page 58 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831647
Page 59 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831648
Page 60 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831649
Page 61 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831650
Page 62 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in
beats/minute:Not Applicable
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831651
Page 63 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831652
Page 64 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831653
Page 65 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831654
Page 66 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831655
Page 67 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not App
licable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831656
Page 68 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831657
Page 69 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831658
Page 70 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831659
Page 71 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831660
Page 72 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/11/2021
2.Date of First Symptom
Started:Jan/7/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/10/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831661
Page 73 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831662
Page 74 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831663
Page 75 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831664
Page 76 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Sample was collected out of window]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV06676]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831665
Page 77 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[will use at home self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831666
Page 78 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831667
Page 79 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831668
Page 80 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1.Not Done Not Done Not Do
ne Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831669
Page 81 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831670
Page 82 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831671
Page 83 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831672
Page 84 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical
Event:Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831673
Page 85 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab TestVendor
NameCollecti
on Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Done Not Do
ne Not Don
e Not Don
e Sponsor-Defi
ned IdentifierTest:Resul
t:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831674
Page 86 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831675
Page 87 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831676
Page 88 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831677
Page 89 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831678
Page 90 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831679
Page 91 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831680
Page 92 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831681
Page 93 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
1.Not Done Not Done Not Do
ne Not Do
ne Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831682
Page 94 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Resu
lt:
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
Not Done Not
Done
Not
Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831683
Page 95 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and
AddressNot Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831684
Page 96 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831685
Page 97 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831686
Page 98 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831687
Page 99 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831688
Page 100 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831689
Page 101 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831690
Page 102 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831691
Page 103 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831692
Page 104 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831693
Page 105 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831694
Page 106 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in
beats/minute:Not Done
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831695
Page 107 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831696
Page 108 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831697
Page 109 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1.Not Done Not Done Not Done Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831698
Page 110 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831699
Page 111 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.Not Done Not Done Not Done Not Done Not D
one Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831700
Page 112 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831701
Page 113 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1.Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831702
Page 114 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831703
Page 115 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/10/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831704
Page 116 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BR2K43]
5.bSample ID [BR2K44]
5.cSample ID [BR2K45]
5.dSample ID [BSHZ1F]
5.eSample ID [BSHZ1G]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831705
Page 117 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Feb/09/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831706
Page 118 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 -
Unscheduled Visit on Feb/09/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ7B7]
5.bSample ID [BRJ7BP]
5.cSample ID [BRJ7BR]
5.dSample ID [BNVKGZ]
5.eSample ID [BNVKH0]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831707
Page 119 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831708
Page 120 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831709
Page 121 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831710
Page 122 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831711
Page 123 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831712
Page 124 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831713
Page 125 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Id
entifie
rAdverse
EventStart DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
1. DELETED ADVERS
E EVENT
1 chills Oct/6/2020
02:00 NO
End Date Time:
Oct/6/2020 16:0
0
Repeating
Pages
2. DELETED ADVERS
E EVENT
2 sore thro
at Oct/6/2020
02:00 NO
End Date Time:
Oct/8/2020 20:0
0
Repeating
Pages
3. ADVERS
E EVENT
3 Nasal Co
ngestion Sep/2/2020
UNK:UNK
NO
End Date Time:
Sep/4/2020 UN
K:UNK
Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831714
Page 126 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[chills]
4.Start Date Time: Oct/6/2020 02:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/6/2020 16:00
6.Toxicity Grade: 1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831715
Page 127 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831716
Page 128 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831717
Page 129 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[sore throat ]
4.Start Date Time: Oct/6/2020 02:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/8/2020 20:00
6.Toxicity Grade: 1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831718
Page 130 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831719
Page 131 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831720
Page 132 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Nasal Congestion]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/4/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831721
Page 133 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831722
Page 134 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831723
Page 135 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedicatio
n ErrorStart Da
teIs the medication er
ror Still OngoingStudy Medication
Errors ActionForm Instan
ce
1.Not App
licable Not Applic
able Not App
licable Not Applicable Not Applicable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831724
Page 136 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831725
Page 137 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
10.Serious Adverse Event
Number: For Pfizer Use
OnlyNot Applicable
[ ]Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831726
Page 138 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nStart D
ateForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not App
licable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831727
Page 139 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.Date: Not Applicable
//Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831728
Page 140 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1.Not Applicabl
e Not Applicab
le Not Applicable Not Applic
able Not Appl
icable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831729
Page 141 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831730
Page 142 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831731
Page 143 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntStart Dat
eForm Instan
ce
1.Not Appli
cable Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831732
Page 144 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831733
Page 145 of 721
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831734
Page 146 of 721
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831735
Page 147 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831736
Page 148 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831737
Page 149 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831738
Page 150 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831739
Page 151 of 721
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831740
Page 152 of 721
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831741
Page 153 of 721
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831742
Page 154 of 721
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831743
Page 155 of 721
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831744
Page 156 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831745
Page 157 of 721
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831746
Page 158 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831747
Page 159 of 721
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831748
Page 160 of 721
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831749
Page 161 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831750
Page 162 of 721
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831751
Page 163 of 721
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hayes
Williams Approved Mar-12-2021 10:21:48 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HayesWilliams, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831752
Page 164 of 721
***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: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-27-2020 08:50:44 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831753
Page 165 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831754
Page 166 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831755
Page 167 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831756
Page 168 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831757
Page 169 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831758
Page 170 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831759
Page 171 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831760
Page 172 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831761
Page 173 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831762
Page 174 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-21-2020 09:42:08 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831763
Page 175 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831764
Page 176 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831765
Page 177 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831766
Page 178 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831767
Page 179 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831768
Page 180 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831769
Page 181 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-21-2020 09:43:01 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831770
Page 182 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:43:35 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831771
Page 183 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:43:35 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831772
Page 184 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:43:35 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831773
Page 185 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:43:35 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831774
Page 186 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:43:35 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831775
Page 187 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831776
Page 188 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831777
Page 189 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831778
Page 190 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831779
Page 191 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831780
Page 192 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831781
Page 193 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831782
Page 194 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831783
Page 195 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831784
Page 196 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831785
Page 197 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831786
Page 198 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831787
Page 199 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831788
Page 200 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831789
Page 201 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831790
Page 202 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831791
Page 203 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831792
Page 204 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831793
Page 205 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831794
Page 206 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831795
Page 207 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831796
Page 208 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831797
Page 209 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831798
Page 210 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831799
Page 211 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831800
Page 212 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831801
Page 213 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831802
Page 214 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831803
Page 215 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831804
Page 216 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831805
Page 217 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831806
Page 218 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831807
Page 219 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:43:51 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831808
Page 220 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831809
Page 221 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831810
Page 222 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831811
Page 223 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831812
Page 224 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831813
Page 225 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831814
Page 226 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831815
Page 227 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831816
Page 228 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831817
Page 229 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831818
Page 230 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831819
Page 231 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831820
Page 232 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831821
Page 233 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831822
Page 234 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831823
Page 235 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831824
Page 236 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831825
Page 237 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831826
Page 238 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831827
Page 239 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831828
Page 240 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831829
Page 241 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831830
Page 242 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831831
Page 243 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831832
Page 244 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831833
Page 245 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831834
Page 246 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831835
Page 247 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831836
Page 248 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831837
Page 249 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831838
Page 250 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831839
Page 251 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831840
Page 252 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831841
Page 253 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831842
Page 254 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831843
Page 255 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831844
Page 256 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831845
Page 257 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831846
Page 258 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831847
Page 259 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831848
Page 260 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831849
Page 261 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831850
Page 262 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831851
Page 263 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831852
Page 264 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-21-2020 09:44:10 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831853
Page 265 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831854
Page 266 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831855
Page 267 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831856
Page 268 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831857
Page 269 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831858
Page 270 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-21-2020 09:47:29 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831859
Page 271 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:47:45 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831860
Page 272 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:47:45 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831861
Page 273 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-21-2020 09:47:45 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831862
Page 274 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:48:02 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831863
Page 275 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:48:02 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831864
Page 276 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:48:02 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831865
Page 277 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:48:02 (UTC-06:00)
Central Time (US & Canada)n/a
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831866
Page 278 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831867
Page 279 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831868
Page 280 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831869
Page 281 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831870
Page 282 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831871
Page 283 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831872
Page 284 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-21-2020 09:48:15 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831873
Page 285 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-21-2020 09:48:29 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831874
Page 286 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-21-2020 09:48:29 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831875
Page 287 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-21-2020 09:48:29 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831876
Page 288 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-21-2020 09:48:29 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831877
Page 289 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-21-2020 09:48:29 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831878
Page 290 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831879
Page 291 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831880
Page 292 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831881
Page 293 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831882
Page 294 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831883
Page 295 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831884
Page 296 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831885
Page 297 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831886
Page 298 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831887
Page 299 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-11-2021 13:12:10 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831888
Page 300 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511060 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-11-2021 13:13:37 (UTC-06:00)
Central Time (US & Canada)not done
Not Done
090177e196ae3d08\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831889
Page 301 of 721
***Confidential***
Header Text: c4591001
Visit: POT_COVI
…[truncated]