125742 S1 M5 CRF c4591001 1251 12511029

Document text

Page 1 of 330
***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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830324
Page 2 of 330
***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: 12511029 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/22/2020
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830325
Page 3 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511029]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830326
Page 4 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/22/2020
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830327
Page 5 of 330
***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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830328
Page 6 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830329
Page 7 of 330
***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: 12511029 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:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Diabetes Mellitus 1]
Start Date: UNK/UNK/2012
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Gout]
Start Date: UNK/UNK/1992
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830330
Page 8 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/22/2020
2.Weight: [285.5]
3.Unit: LB
4.Height: [68.5]
5.Unit: in
6.Body Mass Index: [42.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830331
Page 9 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/22/2020
2.Randomization Number: [237055]
3.Randomization Group: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830332
Page 10 of 330
***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: 12511029 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/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYNT9]
5.bSample ID [BPYNTB]
5.cSample ID [BPYNTC]
5.dSample ID [BNWBG9]
5.eSample ID [BNWBGB]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830333
Page 11 of 330
***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: 12511029 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/22/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYNSH]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830334
Page 12 of 330
***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: 12511029 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/22/2020 08:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830335
Page 13 of 330
***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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830336
Page 14 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830337
Page 15 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830338
Page 16 of 330
***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: 12511029 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/24/2020
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 [BM90DP]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830339
Page 17 of 330
***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: 12511029 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/24/2020 07:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830340
Page 18 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830341
Page 19 of 330
***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: 12511029 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/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 [BR2K06]
5.bSample ID [BR2K07]
5.cSample ID [BR2K08]
5.dSample ID [BSHYW7]
5.eSample ID [BSHYW8]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830342
Page 20 of 330
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830343
Page 21 of 330
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830344
Page 22 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830345
Page 23 of 330
***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: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830346
Page 24 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830347
Page 25 of 330
***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: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830348
Page 26 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830349
Page 27 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/26/2020
2.Date of First Symptom Started: Oct/13/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/15/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830350
Page 28 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descripti
onDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830351
Page 29 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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 Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830352
Page 30 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Oct/26/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV51561]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830353
Page 31 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[SAMPLE WAS COLLECTED BY SUBJECT. WASN'T DONE IN OUR
OFFICE]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830354
Page 32 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830355
Page 33 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830356
Page 34 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830357
Page 35 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830358
Page 36 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830359
Page 37 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830360
Page 38 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830361
Page 39 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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 Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830362
Page 40 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830363
Page 41 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830364
Page 42 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830365
Page 43 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830366
Page 44 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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 Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830367
Page 45 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830368
Page 46 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830369
Page 47 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830370
Page 48 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830371
Page 49 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830372
Page 50 of 330
***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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830373
Page 51 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830374
Page 52 of 330
***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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830375
Page 53 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830376
Page 54 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830377
Page 55 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830378
Page 56 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830379
Page 57 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830380
Page 58 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830381
Page 59 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830382
Page 60 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/23/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830383
Page 61 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/23/2020Form: 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: 12511029 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/23/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8ZTK]
5.bSample ID [BM8ZTL]
5.cSample ID [BM8ZTM]
5.dSample ID [BSHZ4G]
5.eSample ID [BSHZ4H]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830384
Page 62 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830385
Page 63 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830386
Page 64 of 330
***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: 12511029 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830387
Page 65 of 330
***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: 12511029 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: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830388
Page 66 of 330
***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: 12511029 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:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830389
Page 67 of 330
***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: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830390
Page 68 of 330
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this adverse
event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830391
Page 69 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830392
Page 70 of 330
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830393
Page 71 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830394
Page 72 of 330
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830395
Page 73 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830396
Page 74 of 330
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830397
Page 75 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830398
Page 76 of 330
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830399
Page 77 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830400
Page 78 of 330
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830401
Page 79 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830402
Page 80 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 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:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830403
Page 81 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 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?
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830404
Page 82 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830405
Page 83 of 330
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830406
Page 84 of 330
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830407
Page 85 of 330
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830408
Page 86 of 330
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830409
Page 87 of 330
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12511029 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 [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830410
Page 88 of 330
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830411
Page 89 of 330
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830412
Page 90 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830413
Page 91 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830414
Page 92 of 330
***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: 12511029 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: [ ]
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830415
Page 93 of 330
***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: 12511029 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/26/2020
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830416
Page 94 of 330
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12511029 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
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830417
Page 95 of 330
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12511029 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-10-2021 14:57:09 (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.
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830418
Page 96 of 330
***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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-24-2020 07:20:00 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830419
Page 97 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830420
Page 98 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830421
Page 99 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830422
Page 100 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830423
Page 101 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830424
Page 102 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830425
Page 103 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830426
Page 104 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830427
Page 105 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830428
Page 106 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-29-2020 08:48:00 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830429
Page 107 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 12:28:58 (UTC-06:00) Central Time
(US & Canada)
FormOct-29-2020 08:48:56 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830430
Page 108 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 12:28:58 (UTC-06:00) Central Time
(US & Canada)
1Oct-29-2020 08:48:56 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830431
Page 109 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 12:28:58 (UTC-06:00) Central Time
(US & Canada)
2Oct-29-2020 08:48:56 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830432
Page 110 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 12:28:58 (UTC-06:00) Central Time
(US & Canada)
3Oct-29-2020 08:48:56 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830433
Page 111 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 12:28:58 (UTC-06:00) Central Time
(US & Canada)
4Oct-29-2020 08:48:56 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830434
Page 112 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:02:14 (UTC-06:00) Central Time
(US & Canada)SAMPLE COLLECTED BY SUBJECT NOT IN
OUR OFFICE
FormNov-03-2020 13:00:52 (UTC-06:00) Central Time
(US & Canada)
FormOct-29-2020 08:49:19 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830435
Page 113 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:00:52 (UTC-06:00) Central Time
(US & Canada)
1Oct-29-2020 08:49:19 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830436
Page 114 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:00:52 (UTC-06:00) Central Time
(US & Canada)
2Oct-29-2020 08:49:19 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830437
Page 115 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 13:00:52 (UTC-06:00) Central Time
(US & Canada)
3Oct-29-2020 08:49:19 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830438
Page 116 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 13:00:52 (UTC-06:00) Central Time
(US & Canada)
4Oct-29-2020 08:49:19 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830439
Page 117 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830440
Page 118 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830441
Page 119 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830442
Page 120 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830443
Page 121 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830444
Page 122 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830445
Page 123 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-29-2020 08:50:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830446
Page 124 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:51:08 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830447
Page 125 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:51:08 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830448
Page 126 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 08:51:08 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830449
Page 127 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 08:51:08 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830450
Page 128 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 08:51:08 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830451
Page 129 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830452
Page 130 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830453
Page 131 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830454
Page 132 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830455
Page 133 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830456
Page 134 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830457
Page 135 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830458
Page 136 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830459
Page 137 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830460
Page 138 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830461
Page 139 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830462
Page 140 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830463
Page 141 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830464
Page 142 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830465
Page 143 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830466
Page 144 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830467
Page 145 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830468
Page 146 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830469
Page 147 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830470
Page 148 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830471
Page 149 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830472
Page 150 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830473
Page 151 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830474
Page 152 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830475
Page 153 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830476
Page 154 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830477
Page 155 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830478
Page 156 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830479
Page 157 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830480
Page 158 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830481
Page 159 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830482
Page 160 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830483
Page 161 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:51:31 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830484
Page 162 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830485
Page 163 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830486
Page 164 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830487
Page 165 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830488
Page 166 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830489
Page 167 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830490
Page 168 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830491
Page 169 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830492
Page 170 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830493
Page 171 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830494
Page 172 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830495
Page 173 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830496
Page 174 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830497
Page 175 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830498
Page 176 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830499
Page 177 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830500
Page 178 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830501
Page 179 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830502
Page 180 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830503
Page 181 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830504
Page 182 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830505
Page 183 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830506
Page 184 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830507
Page 185 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830508
Page 186 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830509
Page 187 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830510
Page 188 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830511
Page 189 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830512
Page 190 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830513
Page 191 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830514
Page 192 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830515
Page 193 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830516
Page 194 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830517
Page 195 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830518
Page 196 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830519
Page 197 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830520
Page 198 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830521
Page 199 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830522
Page 200 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830523
Page 201 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830524
Page 202 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830525
Page 203 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830526
Page 204 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830527
Page 205 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830528
Page 206 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jOct-29-2020 08:52:07 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830529
Page 207 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830530
Page 208 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830531
Page 209 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830532
Page 210 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830533
Page 211 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830534
Page 212 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-29-2020 08:52:28 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830535
Page 213 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 08:52:45 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830536
Page 214 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 08:52:45 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830537
Page 215 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aOct-29-2020 08:52:45 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830538
Page 216 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 09:00:58 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830539
Page 217 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 09:00:58 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830540
Page 218 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 09:00:58 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830541
Page 219 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 09:00:58 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830542
Page 220 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830543
Page 221 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830544
Page 222 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830545
Page 223 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830546
Page 224 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830547
Page 225 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830548
Page 226 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Oct-29-2020 09:01:15 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830549
Page 227 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-29-2020 09:01:34 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830550
Page 228 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-29-2020 09:01:34 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830551
Page 229 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-29-2020 09:01:34 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830552
Page 230 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-29-2020 09:01:34 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830553
Page 231 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-29-2020 09:01:34 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830554
Page 232 of 330
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
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-10-2021 14:57:09 (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.
 N/A Feb-12-2021 13:14:33 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hayes Williams  Approved Nov-30-2020 16:21:11 (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.
 N/A Nov-23-2020 15:29:31 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hayes Williams  Approved Nov-06-2020 13:02:55 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830555
Page 233 of 330
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830556
Page 234 of 330
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020 07:18:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-24-2020 07:18:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830557
Page 235 of 330
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020 07:19:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/22/2020Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830558
Page 236 of 330
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 07:18:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12511029Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 07:18:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 07:19:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 07:19:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020 07:19:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830559
Page 237 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020 07:19:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/22/2020Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830560
Page 238 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020 07:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 07:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020 07:20:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830561
Page 239 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 07:21:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 07:21:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 07:21:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 07:21:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 07:21:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-26-2020 11:09:51 ACV0PFEINFP6000  Data Entry: New Information
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830562
Page 240 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00) Central Time
(US & Canada)Line/MH Number: 2
Medical History Te
rm:Diabetes Mellit
us 1
Start Date: UNK/UNK/201
2
Ongoing: YES
Aug-24-2020 07:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:Diabetes Mellit
us
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830563
Page 241 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 07:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 04:04:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Closed Response satisfies
query
Aug-26-2020 11:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Aug-26-2020 11:09:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes Mellitus 1New Information
Aug-26-2020 10:57:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Opened Please specify Type I
or II diabetes in the
medical history term if
known.
Aug-24-2020 07:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes MellitusInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020 07:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020 07:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830564
Page 242 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-24-2020 07:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Gout
Start Date: UNK/UNK/19
92
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 07:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 07:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
GoutInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020 07:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020 07:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-24-2020 07:22:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hypercholesterol
emia
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830565
Page 243 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020 07:22:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 07:22:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020 07:22:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020 07:22:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830566
Page 244 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
285.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
68.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
42.8Initial Entry
7.a
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830567
Page 245 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020 07:23:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830568
Page 246 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020 07:23:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020 07:23:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
237055Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830569
Page 247 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 07:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 07:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 07:25:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 07:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-24-2020 07:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 07:25:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYNT9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 07:25:10 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830570
Page 248 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00) Central Time
(US & Canada)BPYNT9
5.b
Date Location User Value Reason
Aug-24-2020 07:25:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYNTBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020 07:25:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYNTBInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 07:25:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYNTCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020 07:25:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYNTCInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020 07:25:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWBG9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-24-2020 07:25:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNWBG9Initial Entry
5.e
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830571
Page 249 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-24-2020 07:26:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWBGBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020 07:26:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNWBGBInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830572
Page 250 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 07:26:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 07:26:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 07:26:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 07:26:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-24-2020 07:26:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 07:26:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYNSHInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 07:26:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830573
Page 251 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00) Central Time
(US & Canada)BPYNSH
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830574
Page 252 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/22/2020 08:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830575
Page 253 of 330
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-24-2020 07:27:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830576
Page 254 of 330
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020 07:27:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830577
Page 255 of 330
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 05:04:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation - PD
tracker updated
Sep-25-2020 09:11:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-25-2020 04:13:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at this
visit is out of window
(10 day) from DOV
(22/Aug/2020) at
V1D1VX1L. Please
either update DOV or
confirm whether visit
is out of window due
to temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-24-2020 08:58:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830578
Page 256 of 330
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 08:59:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 08:59:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Transcription Error
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
23/Sep/2020 is not
same as Date of Visit
24/Sep/2020. Please
review and update as
appropriate or clarify.
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830579
Page 257 of 330
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Unit:
Date Location User Value Reason
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 08:58:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830580
Page 258 of 330
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 08:59:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-24-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 08:59:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM90DPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 08:59:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830581
Page 259 of 330
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00) Central Time
(US & Canada)BM90DP
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830582
Page 260 of 330
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 07:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830583
Page 261 of 330
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-24-2020 09:00:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830584
Page 262 of 330
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-01-2020
01:24:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedOk to have a scheduled visit
same as a COVID visit
Oct-30-2020
10:13:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredOriginal value is correct
Oct-30-2020
05:33:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW5220414;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit COVID_A.
Please review for duplication
and update as appropriate.
Oct-29-2020
08:37:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Oct/26
/2020Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830585
Page 263 of 330
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 08:41:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 08:41:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 08:41:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 08:41:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-29-2020 08:41:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020 08:41:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2K06Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 08:41:23 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0830586
Page 264 of 330
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-06:00) Central Time
(US & Canada)BR2K06
5.b
Date Location User Value Reason
Oct-29-2020 08:41:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2K07Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020 08:41:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR2K07Initial Entry
5.c
Date Location User Value Reason
Oct-29-2020 08:41:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2K08Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020 08:41:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR2K08Initial Entry
5.d
Date Location User Value Reason
Oct-29-2020 08:42:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHYW7Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020 08:42:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSHYW7Initial Entry
5.e
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830587
Page 265 of 330
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-29-2020 08:43:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHYW8Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-29-2020 08:43:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSHYW8Initial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830588
Page 266 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-03-2020
17:49:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-03-2020
11:14:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredIt's not allowing me to enter
self swab information or date?
Oct-31-2020
07:48:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Oct-31-2020
02:14:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dPer response "Subject did a self
swab"; however, data is
missing in Nasal Swab Self.
Please review.
Oct-30-2020
10:21:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredSubject did a self swab
Oct-30-2020
10:20:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredOriginal value is correct
Oct-30-2020
08:38:03
(UTC-06:00)ACV0PFEINFP6000  Query
1: Op
enedDate of Visit is completed but
Date of Collection in both
Nasal Swab Self and Nasal
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830589
Page 267 of 330
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Central Time
(US &
Canada)Swab are missing. Please
review and update as
appropriate.
Oct-30-2020
05:33:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW5220413;The Date of
Visit at Visit COVID_A is the
same as the other Date of Visit
at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Oct-29-2020
08:47:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Del
etedClose Auto Query
Oct-29-2020
08:46:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Can
didateDate of Visit is completed but
Date of Assessment in the
Signs and Symptoms form is
missing. Please review and
update as appropriate.
Oct-29-2020
08:46:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Can
didateDate of Visit is completed but
Date of Collection in both
Nasal Swab Self and Nasal
Swab are missing. Please
review and update as
appropriate.
Oct-29-2020
08:46:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Oct/2
6/202
0Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-29-2020 08:46:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d0b\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830590
Page 268 of 330
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-29-2020 08:47:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-29-2020 08:47:33
(UTC-06:0
…[truncated]