Document text
Page 1 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 version06 OCT 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833194
Page 2 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/27/2020
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833195
Page 3 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [12511262]
2.Birth Date: /1988
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833196
Page 4 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833197
Page 5 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833198
Page 6 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833199
Page 7 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetes mellitus Type 2]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gout]
Start Date: Aug/1/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833200
Page 8 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[epilepsy]
Start Date: Apr/1/2018
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hx of atrial fibrilation]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hepatitis C]
Start Date: UNK/UNK/2018
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[substance abuse disorder]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833201
Page 9 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833202
Page 10 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [240.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [33.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833203
Page 11 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [114126]
3.Randomization Group: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833204
Page 12 of 366
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BR2K1C]
5.bSample ID [BR2K1D]
5.cSample ID [BR2K1W]
5.dSample ID [BSHYX5]
5.eSample ID [BSHYX6]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833205
Page 13 of 366
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BR912T]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833206
Page 14 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: Oct/27/2020 12:43
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
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833207
Page 15 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833208
Page 16 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833209
Page 17 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833210
Page 18 of 366
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/17/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2K4V]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833211
Page 19 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: Nov/17/2020 09:37
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
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833212
Page 20 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833213
Page 21 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
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 [BM900B]
5.bSample ID [BM900C]
5.cSample ID [BM900D]
5.dSample ID [BNVKDC]
5.eSample ID [BNVKDD]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833214
Page 22 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833215
Page 23 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833216
Page 24 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833217
Page 25 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833218
Page 26 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833219
Page 27 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833220
Page 28 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833221
Page 29 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/11/2021
2.Date of First Symptom Started: Jan/7/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/8/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833222
Page 30 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833223
Page 31 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/7/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833224
Page 32 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/7/2021
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]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833225
Page 33 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[subject collected late]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV04075]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833226
Page 34 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 TO SELF SWAB]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833227
Page 35 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833228
Page 36 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833229
Page 37 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
2.HOSPITALIZATION STATUS HOSPITAL Jan/7/2021 NO
Discharge Date:
Jan/8/2021
Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833230
Page 38 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Hospitalization Details
1.Hospitalization Category: Not Done Comments
2.Hospitalization Term: Not Done Comments
3.Admission Date: Not Done
//Comments
4.Ongoing? Not Done Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833231
Page 39 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/7/2021
4.Ongoing? NO
Discharge Date:
Jan/8/2021
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833232
Page 40 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
1.Not Done Not Done Not Done
Not Done
Not Done
Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833233
Page 41 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833234
Page 42 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833235
Page 43 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833236
Page 44 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833237
Page 45 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833238
Page 46 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833239
Page 47 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833240
Page 48 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833241
Page 49 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833242
Page 50 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Done Not Done Not Done Not Done Sponsor-Define
d IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833243
Page 51 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833244
Page 52 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833245
Page 53 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833246
Page 54 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833247
Page 55 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833248
Page 56 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833249
Page 57 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833250
Page 58 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833251
Page 59 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833252
Page 60 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833253
Page 61 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833254
Page 62 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833255
Page 63 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833256
Page 64 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833257
Page 65 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833258
Page 66 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833259
Page 67 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833260
Page 68 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ7CW]
5.bSample ID [BRJ7CX]
5.cSample ID [BRJ7CY]
5.dSample ID [BNVKHS]
5.eSample ID [BNVKHT]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833261
Page 69 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833262
Page 70 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833263
Page 71 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identi
fierAdverse Even
tStart DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 seizure Dec/15/2020 UNK
:UNK NO
End Date Time:
Dec/15/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 moderate dizzi
ness Dec/18/2020 13:48
NO
End Date Time:
Dec/18/2020 14:50
Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833264
Page 72 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[seizure]
4.Start Date Time: Dec/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833265
Page 73 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
[methamphetamine usage 12/13/20 hx of afib]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833266
Page 74 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[moderate dizziness]
4.Start Date Time: Dec/18/2020 13:48
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 14:50
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833267
Page 75 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
[possible vasovagal response]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833268
Page 76 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833269
Page 77 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833270
Page 78 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833271
Page 79 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833272
Page 80 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833273
Page 81 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833274
Page 82 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833275
Page 83 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833276
Page 84 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833277
Page 85 of 366
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833278
Page 86 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833279
Page 87 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833280
Page 88 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833281
Page 89 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833282
Page 90 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833283
Page 91 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833284
Page 92 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833285
Page 93 of 366
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833286
Page 94 of 366
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833287
Page 95 of 366
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833288
Page 96 of 366
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833289
Page 97 of 366
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833290
Page 98 of 366
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833291
Page 99 of 366
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833292
Page 100 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833293
Page 101 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833294
Page 102 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833295
Page 103 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833296
Page 104 of 366
***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: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/18/2020
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833297
Page 105 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833298
Page 106 of 366
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0833299
Page 107 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormOct-28-2020 09:08:01 (UTC-06:00) Central
Time (US & Canada)n/a
Not Applicable
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833300
Page 108 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 07:59:38 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833301
Page 109 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 07:59:38 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833302
Page 110 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 07:59:38 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833303
Page 111 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 07:59:38 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833304
Page 112 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 07:59:38 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833305
Page 113 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833306
Page 114 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833307
Page 115 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833308
Page 116 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833309
Page 117 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833310
Page 118 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833311
Page 119 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6Jan-12-2021 07:59:56 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833312
Page 120 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:01:25 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833313
Page 121 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:01:25 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833314
Page 122 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:01:25 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833315
Page 123 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:01:25 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833316
Page 124 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 08:01:25 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833317
Page 125 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833318
Page 126 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833319
Page 127 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833320
Page 128 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833321
Page 129 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833322
Page 130 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833323
Page 131 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833324
Page 132 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833325
Page 133 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833326
Page 134 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833327
Page 135 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833328
Page 136 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833329
Page 137 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833330
Page 138 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833331
Page 139 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833332
Page 140 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833333
Page 141 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833334
Page 142 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833335
Page 143 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833336
Page 144 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833337
Page 145 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833338
Page 146 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833339
Page 147 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833340
Page 148 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833341
Page 149 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833342
Page 150 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833343
Page 151 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833344
Page 152 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833345
Page 153 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833346
Page 154 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833347
Page 155 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833348
Page 156 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833349
Page 157 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:01:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833350
Page 158 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833351
Page 159 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833352
Page 160 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833353
Page 161 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833354
Page 162 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833355
Page 163 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833356
Page 164 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833357
Page 165 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833358
Page 166 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833359
Page 167 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833360
Page 168 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833361
Page 169 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833362
Page 170 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833363
Page 171 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833364
Page 172 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833365
Page 173 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833366
Page 174 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833367
Page 175 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833368
Page 176 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833369
Page 177 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833370
Page 178 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.dJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833371
Page 179 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833372
Page 180 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833373
Page 181 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833374
Page 182 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.eJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833375
Page 183 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833376
Page 184 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833377
Page 185 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833378
Page 186 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.fJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833379
Page 187 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833380
Page 188 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833381
Page 189 of 366
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833382
Page 190 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.gJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833383
Page 191 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.hJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833384
Page 192 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.hJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833385
Page 193 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.hJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833386
Page 194 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.hJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833387
Page 195 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833388
Page 196 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833389
Page 197 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833390
Page 198 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.iJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833391
Page 199 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833392
Page 200 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833393
Page 201 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833394
Page 202 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5.jJan-12-2021 08:02:07 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833395
Page 203 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833396
Page 204 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833397
Page 205 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aJan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833398
Page 206 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aJan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833399
Page 207 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aJan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833400
Page 208 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aJan-12-2021 08:02:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833401
Page 209 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:02:47 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833402
Page 210 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:02:47 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833403
Page 211 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2.aJan-12-2021 08:02:47 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833404
Page 212 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:03:09 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833405
Page 213 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:03:09 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833406
Page 214 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:03:09 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833407
Page 215 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:03:09 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833408
Page 216 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833409
Page 217 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833410
Page 218 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833411
Page 219 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833412
Page 220 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833413
Page 221 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
5Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833414
Page 222 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
6Jan-12-2021 08:03:28 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833415
Page 223 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormJan-12-2021 08:03:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833416
Page 224 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
1Jan-12-2021 08:03:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833417
Page 225 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
2Jan-12-2021 08:03:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833418
Page 226 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
3Jan-12-2021 08:03:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833419
Page 227 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
4Jan-12-2021 08:03:45 (UTC-06:00) Central
Time (US & Canada)NOT DONE
Not Done
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833420
Page 228 of 366
***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, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-28-2021 10:36:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hayes
Williams Approved Jan-21-2021 12:39:07 (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.
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833421
Page 229 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-28-2020 09:05:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-28-2020 09:05:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833422
Page 230 of 366
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-28-2020 09:05:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/27/2020Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833423
Page 231 of 366
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-28-2020 09:05:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12511262Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-28-2020 09:04:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1988Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-28-2020 09:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-28-2020 09:05:37
(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
Oct-28-2020 09:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMER
ICANInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833424
Page 232 of 366
***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, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 09:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833425
Page 233 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-28-2020 09:08:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 09:08:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 09:08:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833426
Page 234 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Oct-28-2020 09:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Depression
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-28-2020 09:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020 09:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-28-2020 09:08:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-28-2020 09:08:47
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833427
Page 235 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
1.b
Date Location User Value Reason
Oct-28-2020 10:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:diabetes mellit
us Type 2
Start Date: UNK/UNK/20
16
Ongoing: YESChanged
Information
Oct-28-2020 09:09:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:diabetes mellit
us Type 11
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833428
Page 236 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Line/MH Number:
Date Location User Value Reason
Oct-28-2020 09:09:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-28-2020
13:52:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Clo
sedDiscrepancy
has been
closed.
Oct-28-2020
10:47:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged
Information
Oct-28-2020
10:47:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
diabetes mell
itus Type 2Changed
Information
Oct-28-2020
10:25:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Ope
nedClarify
DIABETES
MELLITUS
TYPE 11 as
follows. Are
you reporting
DIABETES
MELLITUS
TYPE 1 or
DIABETES
MELLITUS
TYPE 2? If
reporting any
of these,
please edit as
such. Else
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0833429
Page 237 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
clarify the
term further.
Thank you.
Oct-28-2020
09:09:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
diabetes mell
itus Type 11Initial Entry
1.b Start Date:
Date Location User Value Reason
Oct-28-2020 09:09:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-28-2020 09:09:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-19-2020 11:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:gout
Start Date: Aug/1/20
20
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833430
Page 238 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.c Line/MH Number:
Date Location User Value Reason
Nov-19-2020 11:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-19-2020 11:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
goutInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-19-2020 11:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/1/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-19-2020 11:33:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Dec-28-2020 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:hypertension
Start Date: UNK/UNK/
2007
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833431
Page 239 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.d Line/MH Number:
Date Location User Value Reason
Dec-28-2020 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-28-2020 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Dec-28-2020 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.d Ongoing:
Date Location User Value Reason
Dec-28-2020 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Dec-28-2020 13:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:epilepsy
Start Date: Apr/1/201
8
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833432
Page 240 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.e Line/MH Number:
Date Location User Value Reason
Dec-28-2020 13:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-28-2020 13:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
epilepsyInitial Entry
1.e Start Date:
Date Location User Value Reason
Dec-28-2020 13:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/1/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Dec-28-2020 13:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Dec-31-2020 08:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:hx of atrial fi
brilation
Start Date: UNK/UNK/2
018
Ongoing: YESSubject informed
site via telephone
that onset began in
2018.
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833433
Page 241 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-29-2020 12:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:hx of atrial fi
brilation
Start Date: Dec/15/2020
Ongoing: YESChanged
Information
Dec-28-2020 13:12:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:6
Medical History
Term:atrial fibrila
tion
Start Date: Dec/15/202
0
Ongoing: YESChanged
Information
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:atrial fibrilat
ion
Start Date: UNK/UNK/
2020
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833434
Page 242 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.f Line/MH Number:
Date Location User Value Reason
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-29-2020 12:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hx of atrial fibrilationChanged
Information
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atrial fibrilationInitial Entry
1.f Start Date:
Date Location User Value Reason
Jan-04-2021 01:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-31-2020 08:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto
Query
Dec-31-2020 08:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Subject informed
site via telephone
that onset began in
2018.
Dec-31-2020 07:22:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM1: Per CRF,
Start Date (15/Dec
/2020) is after first
vaccination date
27/Oct/2020.
Please review if
medical condition
started after
Vaccination date if
yes then record
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0833435
Page 243 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
medical condition
on ‘AE’ page. Else
clarify in query
response.
Dec-29-2020 12:38:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered History of atrial
fibrulation. How is
this an AE?
Dec-29-2020 02:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Other query
available.
Dec-29-2020 02:01:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM RQ1: Newly
diagnosed or
worsening medical
condition noted
during the study
must immediately
be reported as an
adverse event.
Please refer CCG
section 8.7 and
update data as
appropriate. Thank
you.
Dec-28-2020 13:13:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Original value is
correct
Dec-28-2020 13:12:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Start Date is after
or equal to the first
vaccination date
27/Oct/2020.
Please review and
update as
appropriate.
Dec-28-2020 13:12:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Changed
Information
Dec-28-2020 13:05:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (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)
FDA-CBER-2021-5683-0833436
Page 244 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
27/Oct/2020.
Please review and
update as
appropriate.
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833437
Page 245 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.f Ongoing:
Date Location User Value Reason
Dec-28-2020 13:04:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Dec-28-2020 13:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:hepatitis C
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833438
Page 246 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.g Line/MH Number:
Date Location User Value Reason
Dec-28-2020 13:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-28-2020 13:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hepatitis CInitial Entry
1.g Start Date:
Date Location User Value Reason
Dec-28-2020 13:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Dec-28-2020 13:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Dec-28-2020 13:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:substance abuse
disorder
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833439
Page 247 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.h Line/MH Number:
Date Location User Value Reason
Dec-28-2020 13:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021 09:50:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-12-2021 09:31:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered substance abuse
was not reported at
initial visit. see
progress notes.
subject meets
criteria.
Jan-12-2021 08:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened clinical: pls advise
1) if hx of
substance abuse
was known at the
time of enrollment
2) confirm subject
meets all I/E
criteria, in
particular
Inclusion 5.1 #2
and Exclusion 5.2
#1 with regard to
hx of SA. Thanks
Dec-28-2020 13:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
substance abuse disorderInitial Entry
1.h Start Date:
Date Location User Value Reason
Dec-28-2020 13:06:35
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833440
Page 248 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
1.h Ongoing:
Date Location User Value Reason
Dec-28-2020 13:06:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833441
Page 249 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-28-2020 09:09:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833442
Page 250 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
240.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833443
Page 251 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.5Initial Entry
7.a
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.6
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833444
Page 252 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-28-2020 09:11:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833445
Page 253 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-28-2020 09:12:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-28-2020 09:12:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
114126Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833446
Page 254 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 09:13:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 09:13:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 09:13:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 09:13:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 09:13:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 09:13:33
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BR2K1CInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833447
Page 255 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 09:13:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2K1CInitial Entry
5.b
Date Location User Value Reason
Oct-28-2020 09:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR2K1DInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 09:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2K1DInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 09:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR2K1WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 09:13:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2K1WInitial Entry
5.d
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833448
Page 256 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-28-2020 09:14:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHYX5Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-28-2020 09:14:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHYX5Initial Entry
5.e
Date Location User Value Reason
Oct-28-2020 09:14:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHYX6Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-28-2020 09:14:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHYX6Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833449
Page 257 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 09:14:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 09:14:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 09:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 09:14:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-28-2020 09:14:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 09:14:45
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BR912TInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833450
Page 258 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 09:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR912TInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833451
Page 259 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020 12:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833452
Page 260 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-28-2020 09:12:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833453
Page 261 of 366
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-28-2020 09:12:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833454
Page 262 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 13:20:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833455
Page 263 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020Initial Entry
2.a
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833456
Page 264 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Nov-17-2020 13:20:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833457
Page 265 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 13:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 13:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 13:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 13:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-17-2020 13:21:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/17/2020Initial Entry
5.a
Date Location User Value Reason
Nov-17-2020 13:23:00
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BR2K4VInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833458
Page 266 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 13:23:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR2K4VInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833459
Page 267 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/17/2020 09:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833460
Page 268 of 366
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-17-2020 13:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833461
Page 269 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 08:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833462
Page 270 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-21-2020 08:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-21-2020 08:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-21-2020 08:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-21-2020 08:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-21-2020 08:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-21-2020 08:49:12
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Sample ID: BM900BInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833463
Page 271 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Dec-21-2020 08:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM900BInitial Entry
5.b
Date Location User Value Reason
Dec-21-2020 08:49:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM900CInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-21-2020 08:49:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM900CInitial Entry
5.c
Date Location User Value Reason
Dec-21-2020 08:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM900DInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-21-2020 08:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM900DInitial Entry
5.d
Date Location User Value Reason
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833464
Page 272 of 366
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-21-2020 08:50:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNVKDCInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-21-2020 08:50:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNVKDCInitial Entry
5.e
Date Location User Value Reason
Dec-21-2020 08:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNVKDDInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-21-2020 08:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNVKDDInitial Entry
090177e196d89028\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0833465
Page 273 of 366
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511262 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 10:36:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-12-2021 23:09:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Jan-12-2021 07:55:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-12-2021 07:54:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(a
…[truncated]