Document text
Page 1 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831165
Page 2 of 425
***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: 12511050 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/25/2020
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831166
Page 3 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511050]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831167
Page 4 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831168
Page 5 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.aDescription of Exclusion Criterion
MetKnown infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831169
Page 6 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831170
Page 7 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12511050 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:[Post menopausal]
Start Date: Oct/17/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tubal Ligation]
Start Date: Feb/27/1992
Ongoing: NO
End Date:
Feb/27/1992
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[R Ankle pain]
Start Date: Mar/UNK/2020
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831171
Page 8 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Hepatitis C]
Start Date: UNK/UNK/2009
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety Disorder]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Smoker]
Start Date: UNK/UNK/1989
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bipolar II Disorder]
Start Date: UNK/UNK/2011
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cyst of Skin Lower Back]
Start Date: UNK/UNK/1999
Ongoing: YES
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831172
Page 9 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major Depressive Disorder]
Start Date: UNK/UNK/2011
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prolapsed Lumbar Intervertebral Disc]
Start Date: UNK/UNK/1997
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Back Pain]
Start Date: UNK/UNK/1997
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[History of Drug Abuse]
Start Date: UNK/UNK/2002
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[History of Adenomatous Polyp of Colon]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831173
Page 10 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831174
Page 11 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [232.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [33.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831175
Page 12 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831176
Page 13 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [239433]
3.Randomization Group: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831177
Page 14 of 425
***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: 12511050 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/25/2020
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 [BPYNTK]
5.bSample ID [BPYNTL]
5.cSample ID [BPYNTM]
5.dSample ID [BNWBHM]
5.eSample ID [BNWBHN]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831178
Page 15 of 425
***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: 12511050 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/25/2020
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 [BPYNFB]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831179
Page 16 of 425
***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: 12511050 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/25/2020 09:40
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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831180
Page 17 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831181
Page 18 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831182
Page 19 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831183
Page 20 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831184
Page 21 of 425
***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: 12511050 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:
Oct/6/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR90M7]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831185
Page 22 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831186
Page 23 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831187
Page 24 of 425
***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: 12511050 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Blood/Swab samples are collected/recorded in Convalescent Visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
5.dSample ID [ ]
5.eSample ID [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831188
Page 25 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831189
Page 26 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831190
Page 27 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831191
Page 28 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831192
Page 29 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831193
Page 30 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831194
Page 31 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831195
Page 32 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/16/2020
2.Date of First Symptom Started: Sep/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
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.aSymptoms - Other Text: [Nasal Drainage]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831196
Page 33 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/16/202
0 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831197
Page 34 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/16/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831198
Page 35 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[She had a Covid Test at her Physician's Office]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831199
Page 36 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject had Covid Test in her Physician's Office]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831200
Page 37 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831201
Page 38 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831202
Page 39 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831203
Page 40 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831204
Page 41 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831205
Page 42 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831206
Page 43 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831207
Page 44 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831208
Page 45 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831209
Page 46 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831210
Page 47 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831211
Page 48 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831212
Page 49 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831213
Page 50 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831214
Page 51 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831215
Page 52 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831216
Page 53 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831217
Page 54 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831218
Page 55 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831219
Page 56 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831220
Page 57 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831221
Page 58 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831222
Page 59 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831223
Page 60 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831224
Page 61 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831225
Page 62 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831226
Page 63 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831227
Page 64 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831228
Page 65 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831229
Page 66 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/03/2020Form: 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: 12511050 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/3/2020
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 [BR2K78]
5.bSample ID [BR2K79]
5.cSample ID [BR2K7B]
5.dSample ID [BSHYZY]
5.eSample ID [BSHYZZ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831230
Page 67 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831231
Page 68 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831232
Page 69 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: PHYSICIAN DECISION
4.Specify Status: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831233
Page 70 of 425
***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: 12511050 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: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831234
Page 71 of 425
***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: 12511050 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:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831235
Page 72 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831236
Page 73 of 425
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 exacerbation of hyperte
nsion Sep/4/2020 UNK:U
NK YES Repeating
Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831237
Page 74 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[exacerbation of hypertension]
4.Start Date Time: Sep/4/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[environmental factors, psychiatric factors]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831238
Page 75 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020361606]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831239
Page 76 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication Er
rorStart DateIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1.Not Applica
ble Not Applicable
Not Applica
ble Not Applicable Not Applicable Repeating
Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831240
Page 77 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of Medication
Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication given? Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831241
Page 78 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831242
Page 79 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831243
Page 80 of 425
***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: 12511050 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.Not Applicable Not Applicable Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831244
Page 81 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831245
Page 82 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Start Date Form Instance
1.Not Applicabl
e Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831246
Page 83 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831247
Page 84 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
1.Not Applicable Not Applicable Repeating Pages
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831248
Page 85 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831249
Page 86 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831250
Page 87 of 425
***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: 12511050 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:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831251
Page 88 of 425
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831252
Page 89 of 425
***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: 12511050 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?
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831253
Page 90 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831254
Page 91 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831255
Page 92 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831256
Page 93 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831257
Page 94 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831258
Page 95 of 425
***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: 12511050 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 [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831259
Page 96 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831260
Page 97 of 425
***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: 12511050 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831261
Page 98 of 425
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831262
Page 99 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831263
Page 100 of 425
***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: 12511050 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: [ ]
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831264
Page 101 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/3/2020
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831265
Page 102 of 425
***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: 12511050 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
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831266
Page 103 of 425
***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: 12511050 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 15:18:30 (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.
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0831267
Page 104 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 14:24:10 (UTC-06:00) Central Time
(US & Canada)subject does not meet inclusion 3 based on new
information withheld by subject at V1.
FormAug-25-2020 10:26:00 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831268
Page 105 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831269
Page 106 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Aug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831270
Page 107 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Aug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831271
Page 108 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Aug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
3Aug-25-2020 10:29:56 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831272
Page 109 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Aug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831273
Page 110 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Aug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831274
Page 111 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aAug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
6.aAug-25-2020 10:29:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831275
Page 112 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aAug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
6.aAug-25-2020 10:29:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831276
Page 113 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aAug-25-2020 10:30:39 (UTC-06:00) Central Time
(US & Canada)not done
Not Done
6.aAug-25-2020 10:29:35 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831277
Page 114 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831278
Page 115 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831279
Page 116 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831280
Page 117 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831281
Page 118 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831282
Page 119 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831283
Page 120 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831284
Page 121 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831285
Page 122 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-09-2020 09:00:41 (UTC-06:00) Central Time
(US & Canada)n/a
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831286
Page 123 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
FormOct-09-2020 09:09:42 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831287
Page 124 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831288
Page 125 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831289
Page 126 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831290
Page 127 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831291
Page 128 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831292
Page 129 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831293
Page 130 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831294
Page 131 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831295
Page 132 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831296
Page 133 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831297
Page 134 of 425
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Nov-06-2020 08:05:47 (UTC-06:00) Central Time
(US & Canada)SUBJECT WILL NOT RECEIVE 2ND
VACCINATION DUE TO CHRONIC HEPATITIS
C-PER INVESTIGATOR
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831298
Page 135 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831299
Page 136 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831300
Page 137 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831301
Page 138 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831302
Page 139 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831303
Page 140 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831304
Page 141 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-04-2020 08:29:41 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831305
Page 142 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:33:38 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831306
Page 143 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:33:38 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831307
Page 144 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:33:38 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831308
Page 145 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:33:38 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831309
Page 146 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:33:38 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831310
Page 147 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831311
Page 148 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831312
Page 149 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831313
Page 150 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831314
Page 151 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831315
Page 152 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831316
Page 153 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831317
Page 154 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831318
Page 155 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831319
Page 156 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831320
Page 157 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831321
Page 158 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831322
Page 159 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831323
Page 160 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831324
Page 161 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831325
Page 162 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831326
Page 163 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831327
Page 164 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831328
Page 165 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831329
Page 166 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831330
Page 167 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831331
Page 168 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831332
Page 169 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831333
Page 170 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831334
Page 171 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831335
Page 172 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831336
Page 173 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831337
Page 174 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831338
Page 175 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831339
Page 176 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831340
Page 177 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831341
Page 178 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831342
Page 179 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:20 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831343
Page 180 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831344
Page 181 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831345
Page 182 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831346
Page 183 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831347
Page 184 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831348
Page 185 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831349
Page 186 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831350
Page 187 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831351
Page 188 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831352
Page 189 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831353
Page 190 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831354
Page 191 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831355
Page 192 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831356
Page 193 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831357
Page 194 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831358
Page 195 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831359
Page 196 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831360
Page 197 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831361
Page 198 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831362
Page 199 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831363
Page 200 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831364
Page 201 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831365
Page 202 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831366
Page 203 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831367
Page 204 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831368
Page 205 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831369
Page 206 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831370
Page 207 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831371
Page 208 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 fNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831372
Page 209 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831373
Page 210 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831374
Page 211 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831375
Page 212 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831376
Page 213 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831377
Page 214 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831378
Page 215 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831379
Page 216 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5 hNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831380
Page 217 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831381
Page 218 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831382
Page 219 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831383
Page 220 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831384
Page 221 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831385
Page 222 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831386
Page 223 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831387
Page 224 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-04-2020 08:34:40 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831388
Page 225 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831389
Page 226 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831390
Page 227 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831391
Page 228 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831392
Page 229 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831393
Page 230 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-04-2020 08:35:01 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831394
Page 231 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:35:17 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831395
Page 232 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:35:17 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831396
Page 233 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-04-2020 08:35:17 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831397
Page 234 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:35:50 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831398
Page 235 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:35:50 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831399
Page 236 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:35:50 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831400
Page 237 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:35:50 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831401
Page 238 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831402
Page 239 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831403
Page 240 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831404
Page 241 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831405
Page 242 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831406
Page 243 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831407
Page 244 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-04-2020 08:36:30 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831408
Page 245 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:36:49 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831409
Page 246 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:36:49 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831410
Page 247 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:36:49 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831411
Page 248 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:36:49 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831412
Page 249 of 425
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:36:49 (UTC-06:00) Central Time
(US & Canada)NA
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831413
Page 250 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831414
Page 251 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831415
Page 252 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831416
Page 253 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831417
Page 254 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831418
Page 255 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831419
Page 256 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831420
Page 257 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831421
Page 258 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831422
Page 259 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831423
Page 260 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Sep-23-2020 09:32:56 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831424
Page 261 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831425
Page 262 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831426
Page 263 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831427
Page 264 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831428
Page 265 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831429
Page 266 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-23-2020 09:33:13 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831430
Page 267 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831431
Page 268 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831432
Page 269 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831433
Page 270 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831434
Page 271 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831435
Page 272 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831436
Page 273 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831437
Page 274 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831438
Page 275 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831439
Page 276 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831440
Page 277 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Sep-23-2020 09:33:36 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831441
Page 278 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831442
Page 279 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831443
Page 280 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831444
Page 281 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831445
Page 282 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831446
Page 283 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831447
Page 284 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Sep-23-2020 09:33:50 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831448
Page 285 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-23-2020 09:34:05 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831449
Page 286 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-23-2020 09:34:05 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831450
Page 287 of 425
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-23-2020 09:34:05 (UTC-06:00) Central Time
(US & Canada)N/A
Not Applicable
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831451
Page 288 of 425
***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: 12511050 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 15:18:30 (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-26-2021 11:28:48 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hayes Williams Approved Nov-09-2020 09:04:47 (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.
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831452
Page 289 of 425
***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: 12511050 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-25-2020 10:24:57
(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-25-2020 10:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831453
Page 290 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 10:25:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0831454
Page 291 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-23-2020 15:03:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed I saw update on the AE log.
Thank you.
Sep-21-2020 18:45:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Subject has a Med hx of
Hypertension from 2010.
In the case of
decompensation of HTN,
the event term could be
consistent with an
hypertensive crisis
(Urgency or emergency).
Please consider revision
and update accordingly.
Thank you.
Sep-21-2020 09:23:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Hypertension is serious
Sep-18-2020 05:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020361606
increased
hypertension(onset
date:04Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-25-2020 10:24:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12511050Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 10:24:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
090177e196ae3d0c\Final\Final On: 01-Apr-2021 04:24 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0831455
Page 292 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-25-2020 10:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 10:25:35
(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-25-2020 10:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERICANInitial Entry
090177e196ae3d0c\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-2021-5683-0831456
Page 293 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 05:59:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-05-2020 16:08:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Updated. Subject
history of Hep C was
unknown and not
reported by Subject.
Nov-05-2020 04:53:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened ClinQuery: the
comment on the vax
CRF indicates subject
has chronic hep C.
Please update inc/ex
CRF as appropriate.
The page has been
unfrozen now. Many
thanks
Nov-03-2020 14:25:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Left comment about
failed criteria. Please
unfreeze page.
Nov-02-2020 03:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened ClinQuery: the
comment on the vax
CRF indicates subject
has chronic hep C.
Please update inc/ex
CRF as appropriate.
Oct-30-2020 12:45:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate ClinQuery: the
comment on the vax
CRF indicates subject
has chronic hep C.
Please update inc/ex
CRF as appropriate.
Oct-29-2020 13:59:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-29-2020 10:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened ClinQuery - please
could you recheck - it
does not look frozen
to me. many thanks
090177e196ae3d0c\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), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0831457
Page 294 of 425
***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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020 09:53:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered inc/ex is frozen please
unfreeze
Oct-29-2020 05:42:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: the
comment on the vax
CRF indicates subject
has chronic hep C.
Please update inc/ex
CRF as appropriate.
Aug-25-2020 10:25:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae3d0c\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-2021-5683-0831458
Page 295 of 425
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - 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: 12511050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
2.a
Date Location User Value Reason
Nov-05-2020 16:04:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Criteri
on Des
criptio
n:Known infection with human
immunodeficiency virus (HIV
), hepatitis C virus (HCV), or
hepatitis B virus (HBV)Initial Entry
2.a Description of Exclusion Criterion Met
Date Location
…[truncated]