125742 S1 M5 CRF c4591001 1260 12601075

Document text

Page 1 of 227
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option
is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836424
Page 2 of 227
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836425
Page 3 of 227
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12601075]
2.Birth Date: 1969
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836426
Page 4 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836427
Page 5 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836428
Page 6 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836429
Page 7 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[allergy to penicillin]
Start Date: Feb/13/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[tendonopathy (feet)]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[tendonopathy (hip)]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[tendonopathy (hands)]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836430
Page 8 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [192.4]
3.Unit: LB
4.Height: [77.0]
5.Unit: in
6.Body Mass Index: [22.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836431
Page 9 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [82226]
3.Randomization Group: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836432
Page 10 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BPT7BW]
5.bSample ID [BNV68G]
5.cSample ID [BNV68H]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836433
Page 11 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BPT7BS]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836434
Page 12 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 09:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836435
Page 13 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836436
Page 14 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836437
Page 15 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836438
Page 16 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BP26SD]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836439
Page 17 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/2/2020 16:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836440
Page 18 of 227
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836441
Page 19 of 227
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP26XM]
5.bSample ID [BNTX7L]
5.cSample ID [BNTX7M]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836442
Page 20 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836443
Page 21 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836444
Page 22 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836445
Page 23 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836446
Page 24 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836447
Page 25 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836448
Page 26 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836449
Page 27 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/8/2020
2.Date of First Symptom Started: Dec/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/9/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? 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? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Abdominal Pain]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836450
Page 28 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locatio
nAssay Code and Descriptio
nDevice Type Form Instance
 1.Not Applicable  Not Applicable
 Not Applicable  Not Applicable  Not Applicabl
e Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836451
Page 29 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836452
Page 30 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/8/2020
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 [CV19195]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836453
Page 31 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[self swab was collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836454
Page 32 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]Comments
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836455
Page 33 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836456
Page 34 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: Not Applicable Comments
2.Hospitalization Term: Not Applicable Comments
3.Admission Date: Not Applicable
//Comments
4.Ongoing? Not Applicable Comments
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836457
Page 35 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836458
Page 36 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836459
Page 37 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 3
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836460
Page 38 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1. DELETED         Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836461
Page 39 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Incomplete, Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event: Comments
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836462
Page 40 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab T
estVendor Na
meCollection Dat
e:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Identif
ierTest
:Result
:Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836463
Page 41 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836464
Page 42 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab
TestVendor Name (DERI
VED)Collection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836465
Page 43 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836466
Page 44 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Dec/8/2020 Record Identifier: Systolic: Diastolic:
1  127  71 Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836467
Page 45 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [127]
Diastolic: [71]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [61]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836468
Page 46 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Dec/8/2020 Record Identifier: Oxygen Saturation
1  100.0 Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836469
Page 47 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/8/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [100.0]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836470
Page 48 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836471
Page 49 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836472
Page 50 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836473
Page 51 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836474
Page 52 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Dec/8/2020  OTHER
If other, specify:
abdomen
 CT SCAN  ABNORMAL
If abnormal, specify findings:
acute appendicitis
 Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836475
Page 53 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/8/2020
2.Location of Assessment: OTHER
If other, specify:
[abdomen]
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[acute appendicitis]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836476
Page 54 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: Not Applicable Comments
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836477
Page 55 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836478
Page 56 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836479
Page 57 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPVNVR]
5.bSample ID [BNTXDD]
5.cSample ID [BNTXDF]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836480
Page 58 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836481
Page 59 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836482
Page 60 of 227
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836483
Page 61 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836484
Page 62 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836485
Page 63 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836486
Page 64 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  soreness at injection site  Sep/8/2020 16:00  NO
End Date Time:
Sep/10/2020 08:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  worsening of tendopathy (h
ands) Oct/18/2020 UNK:
UNK NO
End Date Time:
Nov/1/2020 18:00
 Repeating
Pages
 3.ADVERSE EVE
NT 3  acute appendicitis  Dec/7/2020 22:00  NO
End Date Time:
Dec/8/2020 20:00
 Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836487
Page 65 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[soreness at injection site]
4.Start Date Time: Sep/8/2020 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/10/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836488
Page 66 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening of tendopathy (hands)]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/1/2020 18:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[medical history of tendopathy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836489
Page 67 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836490
Page 68 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[acute appendicitis]
4.Start Date Time: Dec/7/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/8/2020 20:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[acute appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836491
Page 69 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?: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[2020487807]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836492
Page 70 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836493
Page 71 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836494
Page 72 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836495
Page 73 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836496
Page 74 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1. DELETED 1  CORTICOSTERO
IDS NO  prednisone  20-60  Repeating
Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836497
Page 75 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications Pre-specified: NO
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).[prednisone ]
5.Dose: [20-60]
6.Dose Unit: mg
7.Dose Frequency: TID
8.Route: ORAL
9.Start Date: Oct/24/2020
10.Ongoing? NO
End Date:
Nov/2/2020
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836498
Page 76 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836499
Page 77 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836500
Page 78 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836501
Page 79 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836502
Page 80 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836503
Page 81 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836504
Page 82 of 227
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836505
Page 83 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836506
Page 84 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836507
Page 85 of 227
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836508
Page 86 of 227
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836509
Page 87 of 227
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836510
Page 88 of 227
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836511
Page 89 of 227
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836512
Page 90 of 227
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836513
Page 91 of 227
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836514
Page 92 of 227
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836515
Page 93 of 227
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836516
Page 94 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836517
Page 95 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836518
Page 96 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836519
Page 97 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-08-2020 13:36:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836520
Page 98 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-14-2020 17:16:15 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
FormDec-14-2020 17:16:08 (UTC-05:00) Eastern Time
(US & Canada)NA
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836521
Page 99 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836522
Page 100 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836523
Page 101 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836524
Page 102 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836525
Page 103 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836526
Page 104 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836527
Page 105 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836528
Page 106 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836529
Page 107 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Dec-14-2020 17:16:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836530
Page 108 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.bDec-09-2020 15:26:05 (UTC-05:00) Eastern Time (US
& Canada)subject admitted through emergency room for acute
appendicitis
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836531
Page 109 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-02-2021 20:30:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836532
Page 110 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-02-2021 20:30:59 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836533
Page 111 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-02-2021 20:30:59 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836534
Page 112 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-02-2021 20:30:59 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836535
Page 113 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-02-2021 20:30:59 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836536
Page 114 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Incomplete, Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormDec-14-2020 17:11:04 (UTC-05:00) Eastern Time
(US & Canada)NA
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836537
Page 115 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Incomplete, Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Dec-14-2020 17:12:25 (UTC-05:00) Eastern Time (US
& Canada)
2Dec-14-2020 17:12:18 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
2Dec-09-2020 15:42:36 (UTC-05:00) Eastern Time (US
& Canada)acute appendicitis
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836538
Page 116 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-14-2021 11:06:01 (UTC-05:00) Eastern Time (US
& Canada)not applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836539
Page 117 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: DATE OF VISIT - ILLNESS CONVALESCENT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-04-2021 15:56:20 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836540
Page 118 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-17-2021 13:02:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836541
Page 119 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-17-2021 13:02:43 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836542
Page 120 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-17-2021 13:02:43 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836543
Page 121 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-17-2021 13:02:43 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836544
Page 122 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-17-2021 13:02:43 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836545
Page 123 of 227
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-01-2021 15:34:10 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Jan-25-2021 19:18:04 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFinberg, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-09-2020 10:45:18 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-09-2020 12:19:06 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836546
Page 124 of 227
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-08-2020 13:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-08-2020 13:23:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836547
Page 125 of 227
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020 13:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/8/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836548
Page 126 of 227
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-08-2020 13:23:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12601075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020 13:23:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1969Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020 13:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 13:24:20
(UTC-05:00) Eastern 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
Sep-08-2020 13:24:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836549
Page 127 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 13:24:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836550
Page 128 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-08-2020 13:26:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020 13:26:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020 13:26:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836551
Page 129 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-08-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:allergy to penicill
in
Start Date: Feb/13/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-08-2020 13:31:01
(UTC-05:00) Eastern 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
Nov-05-2020 11:52:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-05-2020 11:12:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Nov-05-2020 07:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls update
Med Hx CRF with
relevant information on
tendinopathies in hip,
feet and hands. Thanks.
Nov-05-2020 07:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Candidate clinical: pls update
Med Hx CRF with
relevant information on
tendinopathies in hip,
feet and hands. Thanks.
Sep-08-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
allergy to penicillinInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-08-2020 13:31:01 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836552
Page 130 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-05:00) Eastern Time
(US & Canada)Feb/13/2018
1.a Ongoing:
Date Location User Value Reason
Sep-08-2020 13:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-05-2020 11:08:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:tendonopathy (fe
et)
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Nov-05-2020 11:08:31
(UTC-05:00) Eastern 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
Nov-05-2020 11:08:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tendonopathy (feet)Initial Entry
1.b Start Date:
Date Location User Value Reason
Nov-05-2020 11:08:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-05-2020 11:08:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836553
Page 131 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c
Date Location User Value Reason
Nov-05-2020 11:08:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:tendonopathy (hi
p)
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Nov-05-2020 11:08:47
(UTC-05:00) Eastern 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-05-2020 11:08:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tendonopathy (hip)Initial Entry
1.c Start Date:
Date Location User Value Reason
Nov-05-2020 11:08:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-05-2020 11:08:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-05-2020 11:09:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:tendonopathy (han
ds)
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836554
Page 132 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Nov-05-2020 11:09:23
(UTC-05:00) Eastern 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
Nov-05-2020 11:09:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tendonopathy (hands)Initial Entry
1.d Start Date:
Date Location User Value Reason
Nov-05-2020 11:09:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-05-2020 11:09:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836555
Page 133 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
192.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
77.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.8Initial Entry
7.a
Date Location User Value Reason
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836556
Page 134 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 13:33:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836557
Page 135 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-08-2020 13:33:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 06:53:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-09-2020 19:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-09-2020 19:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
82226Initial Entry
Sep-09-2020 03:55:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response for
"Randomization
Number" is missing?
kindly review and
update.
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836558
Page 136 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 13:34:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 13:34:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 14:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 13:34:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-08-2020 13:34:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 14:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT7BWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 14:42:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT7BWInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836559
Page 137 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Sep-08-2020 14:42:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV68GInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-08-2020 14:42:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNV68GInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020 14:42:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV68HInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-08-2020 14:42:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNV68HInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836560
Page 138 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 13:34:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 13:34:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 14:41:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 13:34:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-08-2020 13:34:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 14:41:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT7BSInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 14:41:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT7BSInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836561
Page 139 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
02:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Closed Auto closed by
Validation Check:
VC_EC001_2_02
Sep-09-2020
19:47:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answer
edChanged data per
query
Sep-08-2020
15:57:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Opened DMW4640711;A
dosing date is
provided on a
Treatment eCRF,
but the patient does
not have a
Randomization
number recorded.
Please review and
update as
appropriate.
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836562
Page 140 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-08-2020
13:35:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 09:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-08-2020 13:35:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836563
Page 141 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-08-2020 13:35:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836564
Page 142 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 07:12:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site confirmation
- updated PD tracker
Oct-06-2020 11:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered there were issues with
the
vaccine/refridgeration on
his scheduled visit date
and he had to be delayed
Oct-06-2020 07:39:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at this visit
is out of window (1 day)
from DOV (08/Sep
/2020) at V1D1VX1L.
Please either update
DOV or confirm
whether visit is out of
window due to
temporary delay of
vaccination/ else provide
details as appropriate.
Oct-02-2020 20:39:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836565
Page 143 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2.a
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 20:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836566
Page 144 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 20:40:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 20:40:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 09:43:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-03-2020 08:21:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-02-2020 20:40:05
(UTC-05:00) Eastern 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-02-2020 20:40:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 09:43:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26SDInitial Entry
5.a Sample ID
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836567
Page 145 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-05-2020 09:43:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP26SDInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836568
Page 146 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-11-2020 16:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-10-2020 07:45:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Oct-09-2020 15:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-09-2020 15:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-09-2020 12:28:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-09-2020 12:28:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened CLINQUERY: The
intent of this question
is to capture only
medically related
events that cause
temporary delays of
vaccination. Per prior
query response, this
delay was not for
medical reasons. Please
update the question
from YES to NO.
Oct-09-2020 12:21:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered sorry-vaccination for
this patient was
delayed due to vaccine
refrigeration issue and
not an AE so the
patient had to return at
a later date and he was
not able to return for
several days. there was
no allergic reaction
with this patient
Oct-09-2020 12:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened 'Was there a temporary
delay of vaccination?'
is marked as Yes and
'Reason(s) for
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836569
Page 147 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temporary Delay of
Vaccination' is not
entered. Please review
and update as
appropriate.
Oct-09-2020 12:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-09-2020 12:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-09-2020 12:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/29/2020
Reason(s) for Temporary Delay of Va
ccinationTranscription Error
Oct-09-2020 11:33:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened CLINQUERY: Please
clarify as there is no
record of CMED
removal for this
subject.
Oct-09-2020 11:31:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened CLINQUERY: Allergic
reaction is not reported
on the AE log for this
subject. Please clarify.
Oct-09-2020 11:21:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answered ae is on log-allergic
reaction
Oct-09-2020 11:21:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered ae-allergic reaction
seen in ER and given
one dose of IV steroids
(was listed on
prohibited med but data
team asked us to
remove it) so
vaccination was
delayed due to that
medication
Oct-09-2020 11:03:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINQUERY: Please
confirm if there is an
AE associated with
corticosteroid treatment
and update the CRF as
appropriate, else
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836570
Page 148 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
clarify.
Oct-09-2020 11:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Please confirm if recent
dose and duration of
systemic corticosteroid
meets criteria for use of
prohibited concomitant
medication as per
protocol section 6.5.1.
If yes, capture on
appropriate CRF.
Thank you.
Oct-09-2020 08:50:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Oct-09-2020 08:50:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/29/2020
Reason(s) for Temporary Delay of Va
ccination
RECENT SYSTEMIC CORTICOS
TEROID TREATMENTTranscription Error
Oct-08-2020 16:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY: The
intent of this question
is to capture only
medically related
events that cause
temporary delays of
vaccination. Per prior
query response, this
delay was not for
medical reasons. Please
update the question
from YES to NO.
Oct-08-2020 07:06:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation, query has
been closed.
Oct-06-2020 11:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered none of the options are
applicable but the
vaccine was delayed
due to refridgeration
issues
Oct-06-2020 11:18:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Was there a temporary
delay of vaccination?'
is marked as Yes and
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836571
Page 149 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
'Reason(s) for
Temporary Delay of
Vaccination' is not
entered. Please review
and update as
appropriate.
Oct-06-2020 11:18:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/29/2020issues with
refridgeration was the
delay
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 16:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836572
Page 150 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
7. Route:
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-02-2020 20:40:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836573
Page 151 of 227
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 09:23:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836574
Page 152 of 227
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020 09:24:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020 09:24:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 12:23:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-03-2020 09:24:19
(UTC-05:00) Eastern 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-03-2020 09:24:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020 12:23:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26XMInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 12:23:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP26XMInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836575
Page 153 of 227
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Nov-03-2020 12:23:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX7LInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 12:23:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX7LInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 12:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX7MInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 12:24:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX7MInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836576
Page 154 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 15:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed data updated
Mar-02-2021 10:46:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered Changed data per query
Feb-21-2021 23:33:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened DM: ‘Hospitalization
Details form' at this
visit still missing.
Please update or else
clarify. Thank you.
Feb-19-2021 16:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered Changed data per query
Feb-18-2021 12:03:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly review and
complete
‘Hospitalization Details
form' at this visit.
Thank you.
Dec-15-2020 03:50:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Dec-14-2020 17:16:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per query
Dec-14-2020 06:41:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly consider to
update missing COVID
TEST form or else
clarify. Thank you.
Dec-09-2020 15:25:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-09-2020 11:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 11:15:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836577
Page 155 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Dec-09-2020 11:15:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 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.
Dec-09-2020 11:15:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-09-2020 11:15:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836578
Page 156 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-09-2020 15:27:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-09-2020 15:27:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Transcription Error
Dec-09-2020 15:25:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of assessment is
not same as Date Visit.
Please check and
correct.
Dec-09-2020 15:25:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-09-2020 15:25:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-22-2021 16:44:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 16:37:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-22-2021 16:37:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Dec/9/2020New Information
Jan-08-2021 08:12:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
clarify whether the
reported symptoms are
still ongoing? If
symptoms have ended,
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836579
Page 157 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
please update
‘Symptoms Ongoing’
on to ‘NO’ and add
Date of Last Symptom
Resolved on the CRF.
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pr
esent:NOInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836580
Page 158 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.b Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec 09 2020 15 23 36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
Symptoms: CHILLS
Symptom Present: YESInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836581
Page 159 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.d Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom P
resent:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec 09 2020 15 23 36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom Pr
esent:NOInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836582
Page 160 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.f Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom P
resent:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE THROA
TInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Dec 09 2020 15 23 36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836583
Page 161 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.h Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-09-2020 15:23:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-04-2021 15:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: Abdominal PainChanged Information
Dec-09-2020 15:24:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
- Other:RLQ abdominal pain cons
istent with appendicitisInitial Entry
5.a Symptoms - Other Text:
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836584
Page 162 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-04-2021 16:13:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-04-2021 15:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-04-2021 15:29:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Abdominal PainChanged Information
Feb-03-2021 13:47:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY: As
subject has SAE of
Appendicitis recorded,
please update the SOD
RLQ abdominal pain
consistent with
appendicitis to
Abdominal Pain.
Dec-09-2020 15:24:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RLQ abdominal pain consistent with ap
pendicitisInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836585
Page 163 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836586
Page 164 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-14-2020 17:16:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836587
Page 165 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 11:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 11:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-09-2020 11:42:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 11:41:48
(UTC-05:00) Eastern 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-09-2020 11:41:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
Date Location User Value Reason
Dec-09-2020 11:42:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV19195Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-09-2020 11:42:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CV19195Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836588
Page 166 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-09-2020 11:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 11:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020 17:15:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-14-2020 17:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Dec-14-2020 17:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-14-2020 17:04:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Dec-11-2020 12:33:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-09-2020 11:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836589
Page 167 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Please review and
correct as appropriate.
Dec-09-2020 11:51:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-14-2020 17:15:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
self swab was collectedInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836590
Page 168 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Dec-14-2020 17:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIALI
ST
Occurrence of Visits or C
ontacts:NOInitial Entry
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIALI
ST
Occurrence of Visits or C
ontacts:Initial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-15-2020 01:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-14-2020 17:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Dec-14-2020 17:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Dec-11-2020 02:01:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
the form and update.
1.b
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGENCY R
OOMInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836591
Page 169 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Occurrence of Visi
ts or Contacts:YES
Number of Visits
or Contacts:
1
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:PRIMARY CARE
PHYSICIAN
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836592
Page 170 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.d
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGENT CARE
Occurrence of Visi
ts or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.e
Date Location User Value Reason
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836593
Page 171 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-14-2020 17:05:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:TELEPHONE CO
NSULTATION
Occurrence of Vis
its or Contacts:NOTranscription Error
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:TELEPHONE CO
NSULTATION
Occurrence of Vis
its or Contacts:YES
Number of Visits
or Contacts:
1Initial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 17:05:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.f
Date Location User Value Reason
Dec-14-2020 17:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:NOInitial Entry
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Cont
acts:Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836594
Page 172 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 17:05:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-02-2021 18:58:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Mar-02-2021 11:20:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 10:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-02-2021 10:45:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive care
due to potential COVID-19 illness?
NOTranscription Error
Feb-19-2021 16:15:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY: Please
confirm if any Labs or
Vasopress assessments
were performed and
update CRF if
applicable.
Feb-19-2021 16:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-19-2021 16:07:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive care
due to potential COVID-19 illness?Transcription Error
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836595
Page 173 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
YES
Feb-17-2021 15:24:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY: Please
record any
hospitalization
information in the
following CRF's vital
signs, pulse oxymet,
respiratory treatment,
lab results,
imaging…)in this
COVID_A visit.
Feb-17-2021 15:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-17-2021 15:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensive care
due to potential COVID-19 illness?
NOChanged Information
Feb-04-2021 16:14:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY: Please
record any
hospitalization
information in the
following CRF's vital
signs, pulse oxymet,
respiratory treatment,
lab results,
imaging…)in this visit.
Feb-04-2021 15:32:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Sorry just confused, do
you want the
hospitalization details
recorded here in inform
somewhere or just have
it in our physical
binder?
Feb-03-2021 13:49:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY: As subject
was hospitalized for
SAE Appendicitis even
though not related to
COVID ILL, please
record Hospitalization
details in this visit on
applicable CRF's.
Dec-09-2020 11:52:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836596
Page 174 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Mar-02-2021 20:26:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Undeleted Transcription
Error
Mar-02-2021 19:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Mar-02-2021 18:59:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Undeleted Transcription
Error
Mar-02-2021 18:59:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Mar-02-2021 14:26:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836597
Page 175 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Mar-02-2021 20:30:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-02-2021 20:26:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-02-2021 14:26:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Mar-02-2021 20:30:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-02-2021 20:26:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-02-2021 14:26:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-02-2021 20:30:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-02-2021 20:26:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-02-2021 14:50:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 14:26:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-02-2021 14:26:47
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0836598
Page 176 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
Mar-02-2021 11:20:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY: Please
complete CRF as
Healthcare CRF
confirms subject was
Hospitalized.
4. Ongoing?
Date Location User Value Reason
Mar-02-2021 20:30:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Mar-02-2021 20:30:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-02-2021 14:26:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Dec/9/2020Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836599
Page 177 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-09-2020 11:53:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-09-2020 11:53:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-09-2020 11:53:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836600
Page 178 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE - Audit Trail
Form Version: 17-Jul-2020 21:55 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Dec-14-2020 17:15:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Dec-09-2020 15:30:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836601
Page 179 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Incomplete, Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-14-2020 17:07:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-09-2020 15:30:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE COVID-19 ILLNESSInitial Entry
2. Subcategory of Clinical Event:
Date Location User Value Reason
Dec-15-2020 02:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as logline is
deleted
Dec-14-2020 17:12:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 17:12:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Dec-14-2020 17:09:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Dec-11-2020 03:13:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response for
"Subcategory of
Clinical Event" is
missing. Kindly review
and update.
3. Was a diagnosis obtained?
Date Location User Value Reason
Dec-15-2020 07:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-14-2020 17:07:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-14-2020 17:07:00
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0836602
Page 180 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Incomplete, Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
(US & Canada)
Dec-11-2020 12:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY: Diagnosis
should be given for
events caused by
significant acute renal,
hepatic, or neurologic
dysfunction. Please
remove or update acute
appendicitis.
Dec-09-2020 15:30:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Diagnosis:
acute appendicitis
Start Date:
Dec/8/2020
Ongoing?:
YESInitial Entry
4. Toxicity Grade:
Date Location User Value Reason
Dec-14-2020 17:07:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Dec-09-2020 15:30:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836603
Page 181 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - COVID - Audit Trail
Form Version: 21-Aug-2020 02:50 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836604
Page 182 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
2.a
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Systolic:: 12
7
Diastolic:: 71
Respiratory Rate in respirations/
minute:18
Heart Rate in beats/minute: 61Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Systolic:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
127Initial Entry
2.a Diastolic:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
71Initial Entry
2.a Respiratory Rate in respirations/minute:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
18Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836605
Page 183 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - COVID - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.a Heart Rate in beats/minute:
Date Location User Value Reason
Feb-19-2021 16:05:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
61Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836606
Page 184 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-19-2021 16:06:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836607
Page 185 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Feb-19-2021 16:06:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
2.a
Date Location User Value Reason
Feb-19-2021 16:06:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Oxygen Saturation: 100.0Initial Entry
2.a Record Identifier:
Date Location User Value Reason
Feb-19-2021 16:06:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a SPO2 Pulse Oximetry %
Date Location User Value Reason
Feb-19-2021 16:06:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
100.0Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836608
Page 186 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: IMAGING - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Dec-09-2020 11:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836609
Page 187 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/08/2020Form: IMAGING - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-09-2020 11:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
2. Location of Assessment:
Date Location User Value Reason
Dec-09-2020 11:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHER
If other, specify:
abdomenInitial Entry
3. Type of Imaging Exam:
Date Location User Value Reason
Dec-09-2020 11:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CT SCANInitial Entry
4. Assessment:
Date Location User Value Reason
Dec-09-2020 11:54:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ABNORMAL
If abnormal, specify findings:
acute appendicitisInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836610
Page 188 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 09:53:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed raised another query on
the SAMP TRK form
Feb-08-2021 09:04:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Closed Alternate query has
been created and this
particular query is
redundant.
Feb-05-2021 03:53:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Please consider to
add form level
comment as "NOT
APPLICABLE” on
SAMP TRK form.
Thank you.
Feb-04-2021 23:59:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Opened Erroneous Visit is
marked, but date of
visit is entered. Please
either untick the
erroneous visit button if
visit occurred, or mark
any forms containing
data within this visit as
Not Done/Not
Applicable at the form
level.
Feb-04-2021 15:29:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered I fixed it as erroneous
visit.
Feb-04-2021 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
either untick the
erroneous visit button if
visit occurred, or mark
any forms containing
data within this visit as
Not Done/Not
Applicable at the form
level.
Jan-25-2021 17:24:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened The form is unlocked.
Thank you!
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836611
Page 189 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-25-2021 14:49:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unlock sample
trk form
Jan-22-2021 01:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Deleted DM query in place
Jan-20-2021 15:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
either untick the
erroneous visit button if
visit occurred, or mark
any forms containing
data within this visit as
Not Done/Not
Applicable at the form
level.
Jan-18-2021 08:54:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Deleted Alternate query present
Jan-14-2021 11:02:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
either untick the
erroneous visit button if
visit occurred, or mark
any forms containing
data within this visit as
Not Done/Not
Applicable at the form
level.
Jan-08-2021 03:13:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Data is not
updated as per query.
Kindly confirm if this
is an erroneous visit if
yes then mark
erroneous visit on this
page and clear data and
add form level
comment ‘Not
Applicable’ on ‘SAMP
TRK’ form. Refer CCG
section 4.10. Else
clarify.
Jan-07-2021 17:12:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Query 1: Answered Changed data per query
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836612
Page 190 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
Dec-28-2020 08:24:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Erroneous Visit is
marked, however date
of visit is entered.
Please either untick the
erroneous visit button if
visit occurred, or mark
any forms containing
data within this visit as
Not Done/Not
Applicable at the form
level.
Dec-26-2020 11:27:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Dec-24-2020 02:43:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Deleted Query is invalid or does
not apply
Dec-23-2020 12:19:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this visit.
Dec-17-2020 04:04:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Per response 'visit
has not happened yet',
kindly mark this visit as
erroneous visit, please
consider adding a form
level comment "not
applicable" by
removing data recorded
on initiated CRFs under
this visit
Dec-09-2020 10:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-04-2021 15:26:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Jan-25-2021 14:48:38
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(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) (6)
(b) (4)
FDA-CBER-2021-5683-0836613
Page 191 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
Jan-20-2021 15:35:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Jan-20-2021 15:35:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-14-2021 11:02:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Jan-07-2021 17:10:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Changed Information
Dec-23-2020 12:19:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-05-2021
02:10:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clo
sedResponse satisfies query
Feb-04-2021
15:56:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not Applica
bleInitial Entry
Feb-04-2021
15:26:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: An
sweredTranscription Error
Feb-04-2021
15:26:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-02-2021
01:34:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: Op
enedDMW7088863;COVID-19
Illness Visit ID in this
convalescent visit is the
same as another
convalescent visit,
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836614
Page 192 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
however date of visit are
different. Please review
and update as appropriate.
Feb-01-2021
15:34:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
Jan-20-2021
15:35:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-07-2021
17:10:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
Dec-17-2020
04:05:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clo
sedDM query placed
Dec-15-2020
09:45:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Rei
ssued:Candi
dateDM: Please update
missing data when visit
occurs. Thank you.
Dec-14-2020
17:17:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredVisit has not happened yet
Dec-11-2020
01:31:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Op
enedDM: The response for
"COVID-19 Illness Visit"
is missing. Kindly review
and update.
Dec-09-2020
11:58:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: wrong area of inform
Dec-09-2020
10:45:17ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836615
Page 193 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-05:00)
Eastern Time
(US & Canada)
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836616
Page 194 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 13:02:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 13:02:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-09-2020 10:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 13:02:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 13:02:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Dec-09-2020 10:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021 01:59:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 7: Closed Response satisfies
query
Feb-17-2021 13:02:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 13:02:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Answered Transcription Error
Feb-17-2021 13:02:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836617
Page 195 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-08-2021 09:53:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 7: Opened DM: Please remove all
data from the form and
then add a FORM level
comment of Not
Applicable by clicking
on the comment icon
located at the top right
of the form.
Jan-14-2021 11:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Closed Close Auto Query
Jan-14-2021 11:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Jan-14-2021 11:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Jan-14-2021 11:03:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Jan-08-2021 07:52:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-07-2021 17:10:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-07-2021 17:10:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020New Information
Dec-17-2020 04:04:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed moved to DOV
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836618
Page 196 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-17-2020 04:02:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened DM: Per response 'visit
has not happened yet',
kindly mark this visit
as erroneous visit,
please consider adding
a form level comment
"not applicable" by
removing data recorded
on initiated CRFs
under this visit
Dec-15-2020 01:15:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Candidate per site's response 'visit
has not happened yet'.
Take further action
once visit done
Dec-14-2020 17:18:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered visit has not happened
yet
Dec-14-2020 17:18:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Dec-14-2020 17:18:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Dec-14-2020 17:18:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Dec-11-2020 12:33:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-09-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Dec-09-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836619
Page 197 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Dec/08/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Dec-09-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020Transcription Error
Dec-09-2020 11:59:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Dec-09-2020 11:59:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-09-2020 11:59:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOinfo in wrong area of
inform
Dec-09-2020 10:45:47
(UTC-05:00) Eastern 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-09-2020 10:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-17-2021 13:02:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Feb-17-2021 13:02:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Jan-14-2021 11:03:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
erroneous visitInitial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (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-2021-5683-0836620
Page 198 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/14/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 11:04:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-04-2021
21:36:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Clo
sedAuto closed by Validation
Check: VC_SV001_10
Feb-04-2021
15:27:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredDec8th conva visit is
erroneous and I just
documented it as so
Feb-02-2021
01:34:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Op
enedDMW7088862;COVID-19
Illness Visit ID in this
convalescent visit is the
same as another
convalescent visit,
however date of visit are
different. Please review
and update as appropriate.
Jan-14-2021
11:04:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3fed\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836621
Page 199 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/14/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-14-2021 11:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-14-2021 11:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-14-2021 16:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-14-2021 11:04:30
(UTC-05:00) Eastern 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.
Jan-14-2021 11:04:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/14/2021Initial Entry
5.a
Date Location User Value Reason
Jan-14-2021 16:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVNVRInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-14-2021 16:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPVNVRInitial Entry
09
…[truncated]