Document text
Page 1 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979170
Page 2 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979171
Page 3 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161059]
2.Birth Date: /1999
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979172
Page 4 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979173
Page 5 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979174
Page 6 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979175
Page 7 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Abdominal Pain undiagonised origin]
Start Date: Aug/UNK/2019
Ongoing: NO
End Date:
Sep/19/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979176
Page 8 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [201.8]
3.Unit: LB
4.Height: [59.5]
5.Unit: in
6.Body Mass Index: [40.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979177
Page 9 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979178
Page 10 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [75043]
3.Randomization Group: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979179
Page 11 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BN65X6]
5.bSample ID [BN65X7]
5.cSample ID [BN65X8]
5.dSample ID [BL9RBF]
5.eSample ID [BL9RBG]
5.fSample ID [BL9RBH]
5.gSample ID [BL9RBJ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979180
Page 12 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BN65LJ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979181
Page 13 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 11:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979182
Page 14 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979183
Page 15 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979184
Page 16 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979185
Page 17 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/22/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979186
Page 18 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP41DK]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979187
Page 19 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/22/2020 14:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979188
Page 20 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979189
Page 21 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BNNRR2]
5.bSample ID [BNNRR3]
5.cSample ID [BP40Z1]
5.dSample ID [BP40Z0]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979190
Page 22 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979191
Page 23 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979192
Page 24 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979193
Page 25 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979194
Page 26 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979195
Page 27 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979196
Page 28 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979197
Page 29 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979198
Page 30 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979199
Page 31 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979200
Page 32 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
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?
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979201
Page 33 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979202
Page 34 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979203
Page 35 of 182
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979204
Page 36 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979205
Page 37 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979206
Page 38 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979207
Page 39 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979208
Page 40 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979209
Page 41 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979210
Page 42 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1. ADVERS
E EVENT
1 Gall Stone Pancre
atitis Sep/13/2020
UNK:UNK NO
End Date Time:
Sep/18/2020 U
NK:UNK
Repeating
Pages
2. ADVERS
E EVENT
2 Choledocholithias
is Sep/13/2020
19:00 NO
End Date Time:
Sep/19/2020 01:
01
Repeating
Pages
3. DELETED Repeating
Pages
4. ADVERS
E EVENT
4 unprotected, heter
osexual intercours
e Nov/23/202
0 UNK:UN
K NO
End Date Time:
Nov/23/2020 22
:00
Repeating
Pages
5. ADVERS
E EVENT
5 maternal exposure
before pregnancy Nov/9/2020
UNK:UNK YES Repeating
Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979211
Page 43 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Gall Stone Pancreatitis]
4.Start Date Time: Sep/13/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/18/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).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
YES
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979212
Page 44 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Undiagnosed preexisiting condition]
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
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020363544]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979213
Page 45 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Choledocholithiasis]
4.Start Date Time: Sep/13/2020 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/19/2020 01:01
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979214
Page 46 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[Patient had underlying, undiagnosed condition]
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
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020363544]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979215
Page 47 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979216
Page 48 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from
the study?
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979217
Page 49 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[unprotected, heterosexual intercourse]
4.Start Date Time: Nov/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/23/2020 22:00
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
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979218
Page 50 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[unprotected, heterosexual intercourse]
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 WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979219
Page 51 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[maternal exposure before pregnancy]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
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
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979220
Page 52 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[unprotected heterosexual intercourse]
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?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979221
Page 53 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979222
Page 54 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979223
Page 55 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979224
Page 56 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979225
Page 57 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979226
Page 58 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979227
Page 59 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979228
Page 60 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979229
Page 61 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979230
Page 62 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979231
Page 63 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979232
Page 64 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979233
Page 65 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979234
Page 66 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979235
Page 67 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979236
Page 68 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979237
Page 69 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979238
Page 70 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979239
Page 71 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979240
Page 72 of 182
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979241
Page 73 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979242
Page 74 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979243
Page 75 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/23/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979244
Page 76 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979245
Page 77 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979246
Page 78 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979247
Page 79 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979248
Page 80 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul
Matherne Approved Mar-04-2021 14:18:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979249
Page 81 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-31-2020 19:04:17 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979250
Page 82 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-01-2020 09:59:30 (UTC-06:00)
Central Time (US & Canada)
FormAug-31-2020 19:04:45 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979251
Page 83 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul
Matherne Approved Mar-04-2021 14:18:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-04-2021 15:01:11 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul
Matherne Approved Oct-27-2020 13:36:21 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979252
Page 84 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020
19:03:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020
19:03:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979253
Page 85 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020
19:03:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Aug/31/2020Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979254
Page 86 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020
19:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11161059Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020
19:02:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1999Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020
19:03:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020
19:03:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979255
Page 87 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-31-2020
19:03:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN
AMERICANInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979256
Page 88 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
19:04:05
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979257
Page 89 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020
19:04:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020
19:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020
19:04:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979258
Page 90 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Oct-01-2020 10:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical
History T
erm:Abdominal Pain
undiagonised ori
gin
Start Dat
e:Aug/UNK/2019
Ongoing: NO
End Date:
Sep/19/2020Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-01-2020 10:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020
10:00:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Abdominal Pain undiago
nised originInitial Entry
1.a Start Date:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979259
Page 91 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-01-2020
10:00:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-01-2020
10:00:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/19/2020Initial Entry
1.b
Date Location User Value Reason
Oct-01-2020 10:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Obesity
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979260
Page 92 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Oct-01-2020 10:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020
10:00:59
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ObesityInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-01-2020
10:00:59
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-01-2020
10:00:59
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979261
Page 93 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
201.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
59.5Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979262
Page 94 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Unit:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
40.1Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:97.2
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979263
Page 95 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada)
7.a Temperature:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
19:05:35
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979264
Page 96 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979265
Page 97 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta
_PX113Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979266
Page 98 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
6.a Result:
Date Location User Value Reason
Aug-31-2020
19:05:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979267
Page 99 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020
19:06:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020
19:06:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
75043Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979268
Page 100 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
19:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
19:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
19:53:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
19:06:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-31-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979269
Page 101 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
19:06:36
(UTC-06:00)
Central Time (US &
Canada)YES
Date of Collection:
Aug/31/2020
5.a
Date Location User Value Reason
Aug-31-2020
19:53:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN65X6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:28
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN65X6Initial Entry
5.b
Date Location User Value Reason
Aug-31-2020
19:53:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN65X7Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979270
Page 102 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN65X7Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020
19:53:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN65X8Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN65X8Initial Entry
5.d
Date Location User Value Reason
Aug-31-2020
19:53:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9RBFInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979271
Page 103 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BL9RBFInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020
19:53:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9RBGInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BL9RBGInitial Entry
5.f
Date Location User Value Reason
Aug-31-2020
19:53:55
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9RBHInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979272
Page 104 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.f Sample ID
Date Location User Value Reason
Aug-31-2020
19:53:55
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BL9RBHInitial Entry
5.g
Date Location User Value Reason
Aug-31-2020
19:54:00
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9RBJInitial Entry
5.g Sample ID
Date Location User Value Reason
Aug-31-2020
19:54:00
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BL9RBJInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979273
Page 105 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
19:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
19:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020
19:59:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
19:06:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-31-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979274
Page 106 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
19:06:50
(UTC-06:00)
Central Time (US &
Canada)YES
Date of Collection:
Aug/31/2020
5.a
Date Location User Value Reason
Aug-31-2020
19:59:58
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN65LJInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
19:59:58
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN65LJInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979275
Page 107 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 11:54Initial Entry
5. Anatomical Location:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979276
Page 108 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020
19:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-31-2020
19:07:21ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979277
Page 109 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US &
Canada)
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979278
Page 110 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020
19:07:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUB
JECTInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979279
Page 111 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020
02:36:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation- not
indicative of
possible COVID
19
Oct-21-2020
16:24:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Participant was
contacted,
investigator
consulted,
clinical picture
not indicative of
possible COVID
19.
Oct-14-2020
10:49:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes"
for the question
"Have you
experienced any
of the
following?” for
the COVID-19
symptoms or
diagnosis on
06OCT2020. But
corresponding
COVID Illness
visit not reported.
Please clarify.
Sep-22-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979280
Page 112 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
18:42:15
(UTC-06:00)
Central Time (US &
Canada)Sep/22/2020
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979281
Page 113 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:97.8
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979282
Page 114 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
18:42:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979283
Page 115 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020
18:03:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-23-2020
18:03:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Transcription
Error
Sep-22-2020
18:42:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Collection Date
21/Sep/2020 is
not the same as
the Date of Visit
22/Sep/2020.
Please correct or
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979284
Page 116 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
confirm.
Sep-22-2020
18:42:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979285
Page 117 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-22-2020 18:42:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020
18:42:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta
_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020
18:42:45
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979286
Page 118 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020
18:03:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-23-2020
05:05:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-22-2020
18:42:53
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979287
Page 119 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)barcodes are
entered. Please
review and
correct as
appropriate.
Sep-22-2020
18:42:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020
18:03:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP41DKInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-23-2020
18:03:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP41DKInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979288
Page 120 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
18:43:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 18:43:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 18:43:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020
18:43:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020 14:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979289
Page 121 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-22-2020 18:43:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
18:43:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 18:43:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 18:43:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-22-2020
18:43:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979290
Page 122 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020
06:56:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Oct-26-2020
12:05:18
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Oct-24-2020
10:28:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
Oct-20-2020
16:35:08
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979291
Page 123 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979292
Page 124 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 16:35:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020
09:37:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji
Prabu RQuery 1: Closed Query raised in
hidden items
Oct-24-2020
04:22:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Hence, please
complete
treatment
disposition CRF
and update date
of EOT to match
the date the Visit
3.
Oct-20-2020
16:35:19ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979293
Page 125 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
12:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-21-2020
05:22:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-20-2020
16:35:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-20-2020
16:35:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979294
Page 126 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-21-2020
12:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNNRR2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
12:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNNRR2Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020
12:18:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNNRR3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
12:18:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNNRR3Initial Entry
5.c
Date Location User Value Reason
Oct-21-2020
12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP40Z1Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979295
Page 127 of 182
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
12:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP40Z1Initial Entry
5.d
Date Location User Value Reason
Oct-21-2020
12:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP40Z0Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020
12:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP40Z0Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979296
Page 128 of 182
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020
12:02:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 12:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020
12:02:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979297
Page 129 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979298
Page 130 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979299
Page 131 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-24-2021
14:58:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979300
Page 132 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Feb-04-2021 15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979301
Page 133 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979302
Page 134 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 17:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 17:58:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Oct-02-2020
13:59:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Oct-01-2020
10:01:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: An
swere
dChanged data per query
Oct-01-2020
08:31:47
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query
3: Rei
ssued:
OpenClinQuery - based on this event of
cholelithiasis in a young woman, please
review and consider recording obesity
(BMI 40.1) in the past medical history
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979303
Page 135 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US &
Canada)ed
Sep-30-2020
04:54:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Clo
sedResponse satisfies query
Sep-30-2020
04:53:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Clo
sedevent recorded in AE CRF
Sep-29-2020
14:42:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: An
swere
dNew Information
Sep-29-2020
14:42:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: An
swere
dNew Information
Sep-29-2020
14:42:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Gall S
tone P
ancre
atitisNew Information
Sep-29-2020
14:42:01ACV0PFEINFP6000 Query
5: AnSAE update was submitted on 29SEP2020
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979304
Page 136 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time
(US &
Canada)swere
d
Sep-25-2020
06:04:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
5: Op
enedSAE RECON:AER#2020363544
Choledocholithiasis(onset
date:13Sep2020)was reported as serious in
Safety database but missing in AE CRF.
Please confirm and update CRF. If safety
update is required, submit a follow-up
SAE Form.
Sep-25-2020
06:01:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Op
enedSAE RECON: AER#2020363544,the term
was updated to 'Gall stone Pancreatitis' in
Safety database while retained as 'Gall
Stones' in AE CRF. Please confirm correct
term.If safety update is required, please
submit a follow-up form.
Sep-25-2020
05:57:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedEvent terms updated in SDB, Pancreatitis
no longer listed. New query issued for new
event issues.
Sep-25-2020
05:57:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedEvent terms updated in SDB, Hepatitis no
longer listed. New query issued for new
event issues.
Sep-22-2020
14:52:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
3: Op
enedClinQuery - based on this event of
cholelithiasis in a young woman, please
review and consider recording obesity
(BMI 40.1) in the past medical history
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979305
Page 137 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-21-2020
04:54:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE RECON:AER#2020363544
PANCREATITIS(onset
date:14Sep2020)was reported as serious in
Safety database but missing in AE CRF.
Please confirm and update CRF. If safety
update is required, submit a follow-up
SAE Form.
Sep-21-2020
04:54:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2020363544Hepatitis(onset
date:14Sep2020)was reported as serious in
Safety database but missing in AE CRF.
Please confirm and update CRF. If safety
update is required, submit a follow-up
SAE Form.
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Gall S
tonesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020
04:55:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-29-2020
14:42:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Sep-29-2020 ACV0PFEINFP6000 Data Entry: New Information
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0979306
Page 138 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
14:42:46
(UTC-06:00)
Central Time (US
& Canada)Sep/13/2020 UNK:UN
K
Sep-25-2020
06:02:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020363544
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-05-2020
11:41:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-01-2020
10:02:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered The pancreatitis
was resolved by
the first
procedure in the
hospital. The
Overall event
was not resolved
until a second
procedure was
completed.
Sep-30-2020
15:34:10ACV0PFEINFP6000 Query 1: Opened CLINICAL The
SAE end date
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979307
Page 139 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US &
Canada)for gall stone
pancreatitis is
Sep 15 at 00:00;
however the AE
end date is Sep
18. Please
review and
update as
required.
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
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).
Date Location User Value Reason
Sep-21-2020
04:39:25
(UTC-06:00)ACV0PFEINFP6000 Query 1: Closed event entered in
SDB
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979308
Page 140 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US
& Canada)
Sep-20-2020
09:39:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:Gall
Stones(Onset
date:14Sep2020)
is not reported on
SAE Report Form
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE CRF
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Gall
Stones: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event a
ssociated with congen
ital anomaly or birth
defect?
NO
Did this serious event
result in death?Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979309
Page 141 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
NO
Did this serious event
require or prolong ho
spitalization?
YES
Did this serious event
result in persistent or
significant disability/i
ncapacity?
NO
Is this serious event li
fe threatening?
NO
Other medically impo
rtant serious event
YES
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.
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979310
Page 142 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event is
due to:
OTHER
If Other, specify:
Undiagnosed preex
isiting conditionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979311
Page 143 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US &
Canada)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-25-2020
05:49:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedoutcome updated in SDB. issue
resolved
Sep-21-2020
04:47:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#11161059,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
RECOVERED/RESOLVED on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a
follow-up form.
Sep-18-2020
17:58:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry
:
RECOVER
ED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020
17:58:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979312
Page 144 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-21-2020
04:39:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020363544Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979313
Page 145 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Sep-29-2020 14:44:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-29-2020 14:44:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-02-2020
13:58:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-02-2020
13:57:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-01-2020
10:05:33
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered Changed data
per query
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979314
Page 146 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-01-2020
10:05:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Sep-30-2020
15:37:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL SAE
information
reports a past
medical History
of Abdominal
Pain since Aug
2019; as relevant
history to this
SAE consider
addition of this
condition to Past
Med History
CRF
Sep-30-2020
15:29:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL On
review of the
SAE report, an
event of sinus
arrhythmia was
noted, yet does
not appear in the
CRF. Please
review for safety
and update AE
log CRF
accordingly.
Sep-29-2020
14:44:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
CholedocholithiasisInitial Entry
4. Start Date Time:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979315
Page 147 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/19/2020 01:01Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
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).
Date Location User Value Reason
Sep-30-2020
04:51:05ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979316
Page 148 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US
& Canada)
Sep-29-2020
14:44:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Choledocholithiasis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-29-2020
14:44:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bir
th defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolong
hospitalization?
YES
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NOInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979317
Page 149 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Is this serious event
life threatening?
NO
Other medically imp
ortant serious event
YES
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.
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event i
s due to:
OTHER
If Other, specify:
Patient had underly
ing, undiagnosed c
onditionInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979318
Page 150 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979319
Page 151 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-29-2020
14:44:39
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-30-2020
04:51:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020363544Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979320
Page 152 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Feb-24-2021
14:58:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-24-2021
14:58:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021
14:58:16
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 Data Entry: Changed
Information
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979321
Page 153 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Canada)
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sinus ArythimaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-24-2021
14:55:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-24-2021
14:56:05
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-26-2020
13:51:48
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979322
Page 154 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-26-2020
12:06:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Yes the event is
ongoing
Oct-26-2020
10:29:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please determine
if this Adverse
Event is still
ONGOING.
Please update or
confirm.
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-24-2021
14:56:16
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979323
Page 155 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
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).
Date Location User Value Reason
Feb-24-2021
14:56:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-24-2021
14:56:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979324
Page 156 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Feb-24-2021
14:57:08
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:
This was likely the
re before and just
undiagnosedInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-24-2021
14:57:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979325
Page 157 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-24-2021
14:57:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-24-2021
14:57:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-24-2021
14:57:52
(UTC-06:00)ACV0PFEINFP6000 Data Entry: Changed
Information
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (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-2021-5683-0979326
Page 158 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Central Time (US &
Canada)
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-24-2021
14:58:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry: Changed
Information
Oct-01-2020
10:04:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979327
Page 159 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Feb-04-2021 15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-04-2021 15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-13-2021
07:52:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Response satisfies
query
Feb-12-2021
14:14:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Closed closed based on
site's response
Feb-10-2021
14:14:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered Ae of maternal
exposure before
pregnancy will be
added as an AE.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979328
Page 160 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-10-2021
07:30:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened CLINICAL_ Per
safety report
(AER#
2021113072), the
additional SAE of
Exposure during
pregnancy has
been reported to
safety. Pls revise
and update AElog
accordingly.
Thanks
Feb-05-2021
16:02:55
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered SEXUAL
RELATIONSHIP
WITH HIV
POSITIVE MALE
IS UNKNOWN
WILL CONTACT
PATIENT TO
OBTAIN THIS
INFORMATION.
Feb-05-2021
06:51:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Svitlana
TonkovydQuery 1: Opened GPD Clin: Can
you please
confirm if this is
or isn't risky
sexual relationship
(unprotected) with
an HIV positive
male? Thanks
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
unprotected, heterosexu
al intercourseInitial Entry
4. Start Date Time:
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979329
Page 161 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-25-2021
08:43:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-24-2021
14:14:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Feb-24-2021
14:14:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/23/2020 22:00Changed
Information
Feb-16-2021
07:05:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please confirm
this AE should
have an END
Date the same as
the START Date
and update the
data. Otherwise,
provide
clarification.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979330
Page 162 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-04-2021
15:18:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
Date Location User Value Reason
Feb-10-2021
14:33:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Feb-10-2021
14:16:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
14:16:57
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NOChanged info per
crf guidelines
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979331
Page 163 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)
Feb-09-2021
02:45:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-08-2021
17:49:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription
Error
Feb-08-2021
17:49:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto
Query
Feb-08-2021
17:49:03
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
NOTranscription
Error
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979332
Page 164 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically import
ant serious event
YES
Feb-05-2021
12:06:53
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 3: Opened SAE RECON:
unprotected,
heterosexual
intercourse is not
reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE
CRF
Feb-05-2021
01:56:57
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 Query 2: Reissued:Open
edOnly the
seriousness
criteria "Other
medically
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979333
Page 165 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada) important serious
event" is
answered, all
other serious
criteria's are left
blank. Please
answer all
seriousness
criteria questions
with "Yes" or
"No" response.
Thank you.
Feb-04-2021
15:16:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered it is a medically
important serious
event; pregnancy
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes',
but at least one
seriousness
criteria is
missing. Please
review and
update as
appropriate.
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
unprotected,
heterosexual
intercourse:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979334
Page 166 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
blank.
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Other medically import
ant serious event
YESInitial Entry
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.
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-04-2021
15:18:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is du
e to:
OTHER
If Other, specify:
unprotected, heterose
xual intercourseNew Information
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is duInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979335
Page 167 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
e to:
OTHER
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-24-2021
14:44:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto
Query
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979336
Page 168 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-24-2021
14:44:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOL
VED WITH SEQUELA
EChanged
Information
Feb-24-2021
14:14:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE
unprotected,
heterosexual
intercourse:
Response to
"What was the
outcome of this
adverse event?"
is 'Unknown' but
End Date/Time
is provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Feb-04-2021
22:48:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-04-2021
15:19:29
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered subject is
currently 12
weeks pregnant,
outcome is
unknown
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
unprotected,
heterosexual
intercourse:
Response to
"What was the
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979337
Page 169 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
outcome of this
adverse event?"
is 'Unknown' but
End Date/Time
is provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Feb-04-2021
15:01:11
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-04-2021
15:01:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979338
Page 170 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021 14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021 14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
maternal exposure before
pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021
14:51:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response
satisfies query
Mar-01-2021
11:40:01ACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UNKChanged
Information
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979339
Page 171 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00)
Central Time (US &
Canada)
Mar-01-2021
11:39:46
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Onset date
updated on SAE
form and faxed
in
Feb-25-2021
17:43:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Open
edIf the date of
09Nov2020 is
accurate, the
start date of this
SAE should be
updated based on
the CRF CG
8.50.2.5.
Feb-24-2021
14:43:00
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Per subject this
date is correct
Feb-16-2021
18:19:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Open
edPer report, "First
day of last
menstrual period
was on
09Nov2020," Pls
clarify
Feb-13-2021
14:09:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered date of onset was
determined by
date of last
menstrual period
per subject
Feb-10-2021
15:41:28
(UTC-06:00)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened As per V12 CRF
CG 8.50.2.5,
Date of onset is
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979340
Page 172 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Central Time (US &
Canada)determined by
ultrasound
results or date of
last menstrual
period. Please
revise/update
accordingly.
Thank you
Feb-10-2021
14:28:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Nov/23/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
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).
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979341
Page 173 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event is
due to:
OTHER
If Other, specify:
unprotected heteros
exual intercourseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-10-2021
14:28:04ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979342
Page 174 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-14-2021
23:14:13
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-13-2021
14:10:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Adverse event is
ongoing as
subject is
pregnant
Feb-10-2021
14:28:04
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE maternal
exposure before
pregnancy:
Response to
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979343
Page 175 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Canada) "What was the
outcome of this
adverse event?"
is 'Unknown'
but End
Date/Time is
provided or "Is
the adverse
event still
ongoing?" is
marked "Yes".
Feb-10-2021
14:28:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-10-2021
14:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979344
Page 176 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
13:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979345
Page 177 of 182
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021
17:32:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
17:30:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-24-2021
17:30:04
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:
eligible and NOT co
nfirmed to have recei
ved only placebo at V
accination 1/2Transcription
Error
Feb-23-2021
13:24:20
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willi
ng to return for Vaccinat
ion 3 OR otherwise not
eligibleInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0979346
Page 178 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-24-2021
17:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021
17:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACC
INATIONInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979347
Page 179 of 182
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 12:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020
19:06:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Aug-31-2020
19:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-08-2021
00:10:53
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-05-2021
16:29:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Participant was
contacted by
CRC and
consulted about
symptoms,
clinical picture
not indicative of
possible COVID
19, therefore
illness visit not
initiated.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979348
Page 180 of 182
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-22-2020
03:50:01
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dRQ1: Response
states ' clinical
picture not
indicative of
possible COVID
19’. Please
confirm if Illness
ediary entry of
10DEC2020 was
deemed
erroneous and
subject had no
symptoms on that
day.
Dec-21-2020
16:25:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Participant was
contacted,
investigator
consulted,
clinical picture
not indicative of
possible COVID
19.
Dec-15-2020
10:44:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes"
for the question
"Have you
experienced any
of the
following?” for
the COVID-19
symptoms or
diagnosis on
10DEC2020. But
corresponding
COVID Illness
visit not reported.
Please clarify.
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979349
Page 181 of 182
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-26-2020
12:02:25
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-31-2020
19:06:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020
19:04:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979350
Page 182 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-27-2020
13:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f2c\Final\Final On: 01-Apr-2021 05:11 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0979351