Document text
Page 1 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901701
Page 2 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/14/2020
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901702
Page 3 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281003]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: NOT REPORTED
5.Race: (Check X all that apply): ASIAN
6.Racial Designation:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901703
Page 4 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901704
Page 5 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901705
Page 6 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901706
Page 7 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anus Surgery (Hemorrhoids)]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Induced Abortion]
Start Date: Jul/UNK/2013
Ongoing: NO
End Date:
Jul/UNK/2013
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Environmental allergy]
Start Date: UNK/UNK/2013
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901707
Page 8 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1994
Ongoing: YES
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901708
Page 9 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [109.56]
3.Unit: LB
4.Height: [62.2]
5.Unit: in
6.Body Mass Index: [19.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901709
Page 10 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/14/2020
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:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901710
Page 11 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [48540]
3.Randomization Group: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901711
Page 12 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BN617F]
5.bSample ID [BN617G]
5.cSample ID [BN617H]
5.dSample ID [BLBBX5]
5.eSample ID [BLBBX6]
5 fSample ID [BLBBX7]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901712
Page 13 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BN616W]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901713
Page 14 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/14/2020 10:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901714
Page 15 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901715
Page 16 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901716
Page 17 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901717
Page 18 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901718
Page 19 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901719
Page 20 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
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:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901720
Page 21 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BN61PR]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901721
Page 22 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/4/2020 11:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?NO
If No, specify reason:
[patient had a work meeting and was unable to stay the full 30 minutes. This was
reviewed with Sub-I and patient left the site 9 minutes after injection]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901722
Page 23 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901723
Page 24 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901724
Page 25 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901725
Page 26 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BP9307]
5.bSample ID [BP9308]
5.cSample ID [BP9309]
5.dSample ID [BLBCDC]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901726
Page 27 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901727
Page 28 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901728
Page 29 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901729
Page 30 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901730
Page 31 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901731
Page 32 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901732
Page 33 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901733
Page 34 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901734
Page 35 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901735
Page 36 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901736
Page 37 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901737
Page 38 of 174
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901738
Page 39 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901739
Page 40 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901740
Page 41 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901741
Page 42 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901742
Page 43 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901743
Page 44 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/21/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901744
Page 45 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901745
Page 46 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901746
Page 47 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1. ADVERSE E
VENT 1 exposure during pr
egnancy Nov/29/2020 UN
K:UNK YES Repeating
Pages
2. DELETED ADVERSE E
VENT 2 miscarriage Dec/22/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901747
Page 48 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[exposure during pregnancy]
4.Start Date Time: Nov/29/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901748
Page 49 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901749
Page 50 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[miscarriage ]
4.Start Date Time: Dec/22/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
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
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:
[miscarriage ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901750
Page 51 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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?:NOT RECOVERED/NOT 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[2020506248 ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901751
Page 52 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Da
teIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901752
Page 53 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901753
Page 54 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901754
Page 55 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901755
Page 56 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901756
Page 57 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901757
Page 58 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901758
Page 59 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901759
Page 60 of 174
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901760
Page 61 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901761
Page 62 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901762
Page 63 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901763
Page 64 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901764
Page 65 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901765
Page 66 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901766
Page 67 of 174
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901767
Page 68 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901768
Page 69 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901769
Page 70 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901770
Page 71 of 174
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901771
Page 72 of 174
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901772
Page 73 of 174
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901773
Page 74 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/21/2020
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Patient reported pregnancy, she withdrew so she could be unblinded]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901774
Page 75 of 174
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901775
Page 76 of 174
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901776
Page 77 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/21/2020
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901777
Page 78 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901778
Page 79 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Lillestol Approved Jan-25-2021 17:43:36 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901779
Page 80 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-14-2020 12:53:03 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901780
Page 81 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Dec-22-2020 16:16:05 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901781
Page 82 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Lillestol Approved Jan-25-2021 17:43:36 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Jan-21-2021 14:58:04 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Lillestol Approved Jan-13-2021 11:31:56 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Jan-05-2021 12:30:26 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Lillestol Approved Jan-05-2021 09:55:27 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901782
Page 83 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, MichaelLillestol, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-21-2020 17:39:25 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Lillestol Approved Oct-12-2020 17:14:48 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Oct-05-2020 14:36:44 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Lillestol Approved Sep-16-2020 11:47:04 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901783
Page 84 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020 12:50:11
(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-14-2020 12:50:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901784
Page 85 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 12:50:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901785
Page 86 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 12:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10281003Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 12:49:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 12:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 12:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT REPORTEDInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 12:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASIANInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901786
Page 87 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020 12:51:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901787
Page 88 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-14-2020 12:52:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 12:52:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 12:52:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901788
Page 89 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 12:54:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Anus Surgery (Hem
orrhoids)
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:54:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:54:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Anus Surgery (Hemorrhoids)Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 12:54:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 12:54:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901789
Page 90 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Aug-14-2020 12:55:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:2
Medical History T
erm:Induced Abort
ion
Start Date: Jul/UNK/2013
Ongoing: NO
End Date:
Jul/UNK/2
013Transcription Error
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Induced Aborti
on
Start Date: Jul/UNK/2013
Ongoing: NO
End Date:
Jun/UNK/2
013Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901790
Page 91 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Induced AbortionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2013Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 12:55:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 12:55:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/UNK/2013Transcription Error
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Term Induced
Abortion End Date is
prior to Start Date.
Aug-14-2020 12:55:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2013Initial Entry
1.c
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901791
Page 92 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 12:55:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Environmental al
lergy
Start Date: UNK/UNK/2013
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:55:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:55:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Environmental allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 12:55:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 12:55:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-14-2020 12:55:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hemorrhoids
Start Date: UNK/UNK/2009Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901792
Page 93 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/2
009
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:55:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:55:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HemorrhoidsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 12:55:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 12:55:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.e
Date Location User Value Reason
Aug-14-2020 12:55:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Myopia
Start Date: UNK/UNK/19
94Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901793
Page 94 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:55:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:55:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MyopiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 12:55:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 12:55:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901794
Page 95 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 13:13:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
109.56Transcription Error
Aug-14-2020 12:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
109.57Transcription Error
Aug-14-2020 12:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 12:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
109.6Transcription Error
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 49.7 is
outside of Normal
Range 25 - 136 for kg
or 50 - 300 for lb.
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
49.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 12:58:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened lb is selected for
weight unit, then in is
expected to be
selected for Height
unit. Please check
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901795
Page 96 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and update data as
appropriate.
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 12:58:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 12:58:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
62.2Transcription Error
Aug-14-2020 12:58:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Height 158 is outside
of Normal Range 140
- 198 for cm or 55 -
80 for in.
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
158.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 12:58:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inTranscription Error
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020 13:13:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.9Transcription Error
Aug-14-2020 12:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.9Transcription Error
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901796
Page 97 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 12:58:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19.9Transcription Error
Aug-14-2020 12:58:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3.1Transcription Error
Aug-14-2020 12:58:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYTranscription Error
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901797
Page 98 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Temperature is greater
than or equal to 38.0
C, however 'FEVER
OR ACUTE
ILLNESS' is not
ticked for the reason
for temporary Delay
of vaccination on
VACCINATION CRF.
Please review and
update as appropriate.
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 98.4 C is
outside of Normal
Range 36.1 - 37.5 C.
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020 12:58:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FTranscription Error
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 12:57:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901798
Page 99 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020 12:57:22
(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-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901799
Page 100 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-14-2020 12:57:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901800
Page 101 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 12:59:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 12:59:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
48540Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901801
Page 102 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 12:59:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 12:59:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 13:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/14/2020Transcription Error
Aug-14-2020 13:02:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-14-2020 13:02:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 13:02:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Aug-14-2020 13:02:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to "Sample
Collected?" is No,
but Barcodes are
present on the page.
Aug-14-2020 12:59:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901802
Page 103 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
according to protocol,
please provide
reason' is missing.
Please review and
update as appropriate.
Aug-14-2020 12:59:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Aug-14-2020 13:02:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN617FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN617FInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020 13:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN617GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN617GInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020 13:02:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN617HInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901803
Page 104 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN617HInitial Entry
5.d
Date Location User Value Reason
Aug-14-2020 13:02:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBBX5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBBX5Initial Entry
5.e
Date Location User Value Reason
Aug-14-2020 13:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBBX6Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBBX6Initial Entry
5.f
Date Location User Value Reason
Aug-14-2020 13:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBBX7Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901804
Page 105 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.f Sample ID
Date Location User Value Reason
Aug-14-2020 13:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBBX7Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901805
Page 106 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 13:03:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 13:03:19
(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-14-2020 13:03:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 13:03:19
(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.
Aug-14-2020 13:03:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 13:03:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN616WInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901806
Page 107 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 13:03:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN616WInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901807
Page 108 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 13:04:06
(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-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020 10:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 13:04:06
(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-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901808
Page 109 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-14-2020 13:04:06
(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-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-14-2020 13:04:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901809
Page 110 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020 13:05:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIA
RY COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901810
Page 111 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 14:37:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901811
Page 112 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901812
Page 113 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901813
Page 114 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901814
Page 115 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901815
Page 116 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901816
Page 117 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 14:37:28 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901817
Page 118 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0901818
Page 119 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 14:37:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901819
Page 120 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 14:37:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 14:37:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 14:37:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 14:37:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 14:37:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 14:37:47 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901820
Page 121 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)ORAL CAVITY
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901821
Page 122 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 14:37:53
(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-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 14:37:53
(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-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901822
Page 123 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 14:37:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901823
Page 124 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 14:38:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 14:38:01
(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-04-2020 14:38:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 14:38:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-04-2020 14:38:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:38:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN61PRInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0901824
Page 125 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020 14:38:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN61PRInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901825
Page 126 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 14:38:41
(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-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 11:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 14:38:41
(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-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901826
Page 127 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-04-2020 14:38:41
(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-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-09-2020 01:38:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed per SITE
response
Sep-08-2020 08:39:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered confirmed. patient
wasn't able to stay the
30 minutes
Sep-08-2020 03:21:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Response to
question for
observation post dose
is 'NO'. Please review
and correct or
confirm.
Sep-07-2020 09:09:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
If No, specify reason:
patient had a work meeting and
was unable to stay the full 30 mi
nutes. This was reviewed with S
ub-I and patient left the site 9 mi
nutes after injectionTranscription Error
Sep-04-2020 14:38:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901827
Page 128 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 14:36:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901828
Page 129 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901829
Page 130 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901830
Page 131 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901831
Page 132 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901832
Page 133 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOIN
T PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901833
Page 134 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 14:39:02 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901834
Page 135 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TEInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901835
Page 136 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site react
ions present on the last d
ay the Subject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 14:39:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901836
Page 137 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 14:39:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 14:39:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 14:42:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 14:39:13
(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-05-2020 14:39:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 14:42:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9307Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901837
Page 138 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-05-2020 14:42:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9307Initial Entry
5.b
Date Location User Value Reason
Oct-05-2020 14:42:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9308Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 14:42:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9308Initial Entry
5.c
Date Location User Value Reason
Oct-05-2020 14:42:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9309Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 14:42:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP9309Initial Entry
5.d
Date Location User Value Reason
Oct-05-2020 14:42:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBCDCInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-05-2020 14:42:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLBCDCInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901838
Page 139 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-07-2020 08:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 08:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 08:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901839
Page 140 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-22-2021 13:02:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-22-2021 12:31:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Jan-22-2021 10:21:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened New information after
discontinuation should
only be reported in the
Safety database!
Therefore ensure all
applicable updates to
CRFs are removed and
set back to time of
discontinuation. Thank
You!
Jan-20-2021 08:57:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered the start date was after
the date of
discontinuation so
does the whole AE
need to be removed?
Jan-19-2021 08:03:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: No date should
be entered AFTER the
disposition follow-up
date. If the miscarriage
occured after the date
the subject was
withdrawn, then the
stop date should be
removed on the AE
OR the disposition
follow-up date should
be updated.
Jan-19-2021 05:54:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Accepted per protocol
AEs will be collected
from the time the
participant/parent(s)
/legal guardian
provides informed
consent to
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901840
Page 141 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
approximately 6
months after the last
dose of study
intervention (Visit 8
for Phase 1
participants, and Visit
4 for Phase 2/3
Jan-13-2021 10:15:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered patient notified site on
21Dec and withdrew
from the trial.
Miscarriage happened
22Dec. Patient notified
site on 28Dec of
miscarriage
Jan-13-2021 07:15:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Please reconcile this
date, AE "Miscarriage"
reported with start of
22Dec2020 after the
follow up disposition
date. Please review
and update as
appropriate. Else
clarify.
Jan-05-2021 12:30:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-05-2021 12:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Jan-26-2021
07:43:59
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
ClosedPer TRT UNBLN CRF:
"Patient reported
pregnancy, she withdrew
so she could be
unblinded." Also query
audit trail on DISP
STATUS indicates no
pregnancy tests
performed at the site
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901841
Page 142 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(with collection date
on/before DISP date)
were positive.
Jan-26-2021
05:36:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
Reissued
:OpenedPlease clarify
where/which pregnancy
test was performed
leading to a positive
result.
Jan-25-2021
11:24:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 4:
Answere
dnone of the pregnancy
tests done were positive
at the site.
Jan-25-2021
01:03:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query 4:
OpenedDMW6937448;Response
to 'Status' is
PREGNANCY, but there
is no pregnancy tests
with a positive result
with a 'Collection Date'
on or before the
disposition date. Please
review and update as
appropriate.
Jan-12-2021
16:44:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2:
ClosedResponse satisfies query
Jan-12-2021
16:35:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
ClosedClose Auto Query
Jan-12-2021
16:34:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3:
OpenedResponse to "Status" is
PREGNANCY but
"Specify Status" is
Provided.
Jan-12-2021 ACV0PFEINFP6000 auto query Query 2: Changed Information
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901842
Page 143 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
16:34:39
(UTC-06:00)
Central Time
(US &
Canada)(autoquery) Answere
d
Jan-12-2021
16:34:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
PREGN
ANCYChanged Information
Jan-12-2021
16:19:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2:
Reissued
:OpenedCLINQUERY: Per CRF
guidelines, if an adverse
event contributed to
withdrawal then this
status should indicate
that. AE#1 is also
reported to have led to
study discontinuation.
Please consider status
PREGNANCY as the
underlying cause of
discontinuation
Jan-05-2021
15:50:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Answere
dChanged data per query
Jan-05-2021
13:57:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2:
OpenedCLINQUERY: Since
withdrawal was linked to
the Pregnancy per
Specify, Status comment
(and AE entry indicates
discontinuation due to
that event) please update
status to match
Jan-05-2021
12:30:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
ClosedClose Auto Query
Jan-05-2021
12:30:26ACV0PFEINFP6000 auto query
(autoquery)Query 1:
OpenedResponse to "Status" is
WITHDRAWAL BY
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901843
Page 144 of 174
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time
(US &
Canada)SUBJECT but "Specify
Status" is missing.
Jan-05-2021
12:30:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
WITHD
RAWAL
BY SUB
JECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Jan-12-2021 16:35:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Changed Information
Jan-05-2021 15:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Patient withdrew in order to be unbl
inded due to exposure during pregn
ancy AE 1Changed Information
Jan-05-2021 15:49:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Patient withdrew in order to be unbl
inded due to pregnancyChanged Information
Jan-05-2021 12:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Patient withdrew due to finding out
she was pregnantInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901844
Page 145 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901845
Page 146 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-22-2021 12:30:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901846
Page 147 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020 17:39:25
(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 Value Reason
Mar-08-2021 01:59:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed acceptable discrepancy.
Feb-25-2021 08:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 9: Closed belongs on partner
Feb-25-2021 08:55:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 9: Opened Clinical SAE update 17Feb
has "On 28Dec2020, the
subject informed that she
had a miscarriage and
started bleeding on
22Dec2020. She had blood
work done with her doctor
and confirmed she was no
longer pregnant." Please
re-add Miscarriage SAE if
correct
Feb-22-2021 21:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 8: Closed Response satisfies query
Feb-17-2021 10:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 8: Answered I looked at the report and it
says miscarriage of
pregnant partner. I will
resend.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901847
Page 148 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-16-2021 12:01:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 8: Opened Clinical Event term is
EDP; however, the most
recent Event report
(#2020506248) on
02Feb21 still has the event
term Miscarriage. Please
send a safety update to this
report with the current EDP
term, and dates/serious
criteria (none) for the EDP
event
Feb-16-2021 11:53:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 7: Closed Response satisfies query
Feb-09-2021 09:24:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 7: Answered this was added under the
partner patient 10281033.
Miscarriage was asked to
be removed for the patient
Feb-09-2021 09:22:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Closed mother unblinding date was
submitted to safety report
Feb-09-2021 09:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 7: Opened Clinical Event term is
EDP; however, SAE report
(2020506248) for this
subject has event term
'Miscarriage'. As
miscarriage occurred after
subject's study termination
& cannot be added to CRF,
please send safety update to
restore original EDP event
term
Feb-02-2021 16:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered that father was not
unblinded. only the mother
was.
Feb-02-2021 14:44:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Reissued:Opened Clinical If the mother
(10281003) was unblinded,
please record on the
Exposure during PG
(non-serious) safety report.
If the father (10281033)
was unblinded, lease record
on the Pregnancy SAE (this
should have a NEW unique
SAE number)
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901848
Page 149 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-01-2021 10:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Answered case 2020506248 is for
patient 10281033. This has
been updated and faxed in.
Jan-30-2021 22:40:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 6: Opened Clinical Please submit a
PG Safety update
(#2020506248) stating the
exact date of unblinding
(21Dec20
Jan-28-2021 17:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies query
Jan-28-2021 09:20:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered per data management,
nothing should be entered
after the date of
withdrawal. as the start and
stop date of the miscarriage
was 1 day after withdrawal,
this was removed per
query.
Jan-27-2021 19:57:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Opened Clinical - The SAE of
Miscarriage has been
incorrectly deleted. Please
follow the 'Undelete'
instructions in the CRF
completion guidelines Sect
4.11.1 (at the end of the
Delete Section) to return
the SAE
Jan-26-2021 08:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Candidate Pending SDB update
Jan-25-2021 11:25:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered will remove in safety
database. As it was asked
to be removed per query.
Jan-25-2021 06:58:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened SAE
RECON:AER#2020506248
Miscarriage(onset
date:22Dec2020)was
reported as serious in
Safety database but deleted
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901849
Page 150 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-04-2021 15:05:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Jan-04-2021 09:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered added new event as AE
Dec-31-2020 10:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - please update this
exposure during pregnancy
event report to Miscarriage
(a SAE; #2020506248;
with new dates and other
answer reponses)
Dec-31-2020 10:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Dec-29-2020 10:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
exposure during pregnancyTranscription Error
Dec-29-2020 10:48:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Dec-29-2020 10:48:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
miscarriageChanged Information
Dec-24-2020 10:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Dec-22-2020 21:30:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Event term is
Exposure during
Pregnancy; however, SAE
event term is Pregnancy.
Per 03Nov20 guidance
(study communication),
healthy pregnancy is not an
AE. Term for SAE report
should also be Exposure
during pregnancy; please
submit a SAE update
Dec-22-2020 11:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Dec-22-2020 11:29:05 ACV0PFEINFP6000 Data Entry: Changed Information
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901850
Page 151 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)exposure during PREGNAN
CY
Dec-22-2020 08:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020506248, the
term in both database was
reported as PREGNANCY.
Per 3 Nov EDP guidance
(study communication),
term should be recorded as
Exposure during
pregnancy. Please confirm
and update accordingly.
Dec-21-2020 17:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/29/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 14:34:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed confirmed ongoing at
disposition
Jan-22-2021 14:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Jan-22-2021 13:23:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Changed data per query
Jan-22-2021 13:22:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened 'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Jan-22-2021 13:22:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901851
Page 152 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021 13:22:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged Information
Jan-22-2021 13:11:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Since the ‘End Date' is after
‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF it needs to
be updated to the the
information as to the time
of discontinuation. Please
clarify or correct.
Jan-22-2021 13:04:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Jan-22-2021 09:22:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-22-2021 09:22:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKTranscription Error
Jan-22-2021 09:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Jan-22-2021 09:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Jan-22-2021 09:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESChanged Information
Jan-22-2021 02:19:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: No date should be
entered AFTER the
disposition follow-up date.
Kindly review dates and
update CRF as appropriate.
Please connect with CRA in
case further assistance
needed.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0901852
Page 153 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
5. Is the adverse event still ongoing?
Date Location User ValueReason
Jan-21-2021
12:27:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredclarifying with sponsor if
the whole event should be
removed.
Jan-21-2021
12:07:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6938954;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Dec-29-2020
10:46:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NO
End
Date
Tim
e:
De
c/2
2/2
02
0
U
N
K:
U
N
KNew Information
Dec-22-2020
16:16:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YESInitial Entry
Dec-21-2020
17:41:55
(UTC-06:00)ACV0PFEINFP6000 Data
Entry
:Transcription Error
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901853
Page 154 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US &
Canada)
Dec-21-2020
17:39:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020 16:16:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial 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
Jan-02-2021 02:37:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Deleted Close Auto Query
Dec-29-2020 10:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE exposure
during pregnancy:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Dec-29-2020 10:48:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE miscarriage:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901854
Page 155 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-22-2020 21:25:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-22-2020 21:24:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-22-2020 16:16:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Candidate For AE exposure
during
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'No' but
"Serious Adverse
Event Number" is
present.
Dec-22-2020 16:16:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed Information
Dec-22-2020 16:16:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Dec-22-2020 16:16:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOChanged Information
Dec-22-2020 15:15:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Dec-22-2020 14:03:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Candidate Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Dec-22-2020 14:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical As per CRF
CG 8.50.2.5, an
“Exposure During
Pregnancy” is NOT
an SAE [despite
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901855
Page 156 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
using similar forms
to report pregnancy];
only abnormal
outcomes of
pregnancy are
evaluated for serious
criteria. Please
update.
Dec-22-2020 11:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-22-2020 11:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YESChanged Information
Dec-22-2020 07:23:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901856
Page 157 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-21-2020 17:39:25
(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.
Dec-21-2020 17:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
PREGNANCY:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Dec-21-2020 17:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Other medically important seri
ous 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
Dec-21-2020 17:39:25
(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
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901857
Page 158 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Dec-21-2020 17:39:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020 17:39:25
(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
Jan-22-2021 13:22:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDChanged Information
Dec-29-2020 10:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Dec-29-2020 10:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-29-2020 10:46:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE exposure
during
PREGNANCY:
Response to "What
was the outcome of
this adverse event?" is
'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Dec-22-2020 16:17:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-22-2020 16:17:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDChanged Information
Dec-22-2020 16:16:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE exposure
during
PREGNANCY:
Response to "What
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901858
Page 159 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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".
Dec-21-2020 17:41:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-21-2020 17:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
PREGNANCY:
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".
Dec-21-2020 17:39:25
(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
Jan-05-2021 13:58:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Jan-05-2021 12:31:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Jan-05-2021 11:28:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Please
complete the FUP tab
to register no further
visits
Dec-29-2020 10:49:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered patient withdrew
from participation,
but would allow us to
collect information
on her.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901859
Page 160 of 174
***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, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-23-2020 08:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Entry
of 'YES' indicates
subject will no longer
complete follow up
on the study. Please
review if correct. If
correct, please update
the FUP tab to
indicate end of study
Dec-21-2020 17:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-02-2021 02:37:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: downgraded to non
serious
Dec-22-2020 08:30:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020506248Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901860
Page 161 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-29-2020 12:49:34
(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
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
miscarriageInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021
13:06:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clos
edResponse satisfies query
Jan-22-2021
12:30:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Del
etedChanged Information
Jan-22-2021
12:30:43
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Query
2: Ans
weredChanged data per query
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901861
Page 162 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Canada)
Jan-22-2021
10:25:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Reis
sued:O
penedNew information after
discontinuation should only
be reported in the Safety
database! Therefore ensure
all applicable updates to
CRFs are removed and set
back to time of
discontinuation. Thank
You!
Jan-22-2021
01:19:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Reis
sued:C
andida
teDM: Please update when
data is available per query
response provided.
Jan-21-2021
12:27:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredclarifying with sponsor if
the whole event should be
removed.
Jan-21-2021
10:57:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredawaiting on response from
the sponsor if this whole
event should be removed.
Jan-21-2021
10:57:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Ope
nedDMW6937944;Start Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Jan-21-2021
09:49:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6937944;Start Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Dec-29-2020
12:49:34
(UTC-06:00)ACV0PFEINFP6000 Data
Entry:
Dec/2Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0901862
Page 163 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Central Time
(US &
Canada)2/2020
UNK:
UNK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021
09:49:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clos
edResponse satisfies query
Jan-21-2021
20:39:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clos
edAuto closed by Validation
Check: VC_AE001_10_AN
Jan-21-2021
14:58:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredOriginal value is correct
Jan-21-2021
14:58:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ope
ned'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Jan-21-2021
14:58:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
YESChanged Information
Jan-21-2021
12:27:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredclarifying with sponsor if
the whole event should be
removed.
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901863
Page 164 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-21-2021
12:07:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW6938959;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Dec-29-2020
12:49:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry:
NO
End
Date
Time
:
Dec
/22/
202
0 U
NK
:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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
Jan-04-2021 15:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Jan-04-2021 09:27:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901864
Page 165 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-04-2021 09:27:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
YESChanged Information
Jan-02-2021 02:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020506248
Miscarriage(onset
date:22Dec2020)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.
Jan-02-2021 02:37:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be addressed
internally
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901865
Page 166 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-02-2021 02:36:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE miscarriage:
Response to "Is the adverse
event serious?" is 'No' but
"Serious Adverse Event
Number" is present.
Dec-29-2020 12:49:34
(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
Dec-29-2020 12:49:34
(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
Dec-29-2020 12:49:34
(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:
miscarriageInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-29-2020 12:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901866
Page 167 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-29-2020 12:49:34
(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
Jan-21-2021 14:58:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-21-2021 14:58:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE miscarriage: Response to
"What was the outcome of this
adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Jan-21-2021 14:58:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NO
T RESOLVEDChanged Information
Jan-06-2021 05:21:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Jan-05-2021 09:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated form and is waiting PI
signature. Will send in today
Jan-05-2021 06:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020506248,outcome
was reported as UNKNOWN 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.
Dec-29-2020
12:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901867
Page 168 of 174
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Dec-29-2020 12:49:34
(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
Jan-02-2021 02:36:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2020506248Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901868
Page 169 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-13-2021 05:57:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Inconsistent
unblinding dates in
Inform & IVRS have
been investigated @
site by CTM. Site's
NTF explains
unblinding date =
21Dec2020 but site
didn't add ublinding
event in IVRS until
07Jan2021 & per
IVRS team,
07Jan2021 date in
IVRS can't be
changed.
Jan-11-2021 10:15:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered I entered a DCF to
impala and was told
the status date could
not change, and that
the site has to write a
note to file explaining
what happened.
Jan-11-2021 04:07:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Other query raised.
Jan-11-2021 04:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened IVRS Q1: Date Blind
broken at Impala and
Date treatment
unblinded is expected
to be same. Response
provided 'I could not
change date of
un-blinding to
21Dec2020.' is not
satisfactory. Please
update date or
provide appropriate
reason for not
changing date.
Jan-11-2021 03:48:46 ACV0PFEINFP6000 Query 1: Reissued:Candidate review in next IVRS
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901869
Page 170 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)recon: if still
unresolved, please
add to vendor issue
log for update from
07Jan2021 to
21Dec2020.
Jan-08-2021 15:39:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered confirmed. wasn't
originally done in
impala. I entered a
DCF and they told me
I could not change
date of unblinding to
21Dec2020.
Jan-08-2021 01:45:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS Reconciliation:
Date Blind broken
07Jan2021 at Impala
is not matching with
Date treatment
Unblinded
21Dec2020. Please
check and update data
as appropriate. Else,
clarify. Thank you.
Dec-21-2020 17:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/21/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-11-2021 03:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Closed as data is
updated in Impala.
Jan-05-2021 09:21:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered patient was not
blinded in impala,
however, the blind
was broken by the
study coordinator and
unblinded injector
Jan-05-2021 07:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Per query
response 'the patient
was unblinded, it just
wasn't completed in
impala.' and comment
for other Specify field
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901870
Page 171 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
it appears response to
'Blind Broken' at
Impala needs to be
corrected to 'Yes'.
Please update data as
appropriate. Else,
clarify.
Jan-05-2021 07:13:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed other query raised.
Jan-04-2021 09:26:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered the patient was
unblinded, it just
wasn't completed in
impala.
Dec-31-2020 02:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM2: Per response
'patient was not
unblinded in impala.'.
Please confirm if this
form is completed in
error. If yes, update
data as appropriate.
Else, clarify. Thank
you.
Dec-29-2020 11:04:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered patient was not
unblinded in impala.
do we need to have
the PI go in and do
this?
Dec-23-2020 02:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Per response,
kindly update the
eCRF data after
checking with the
coordinator. Change
the query status to
answered once data is
updated or confirmed.
Thank you.
Dec-22-2020 11:27:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000
)Query 1: Answered break blind was not
performed in impala
that I'm aware. I'm
checking with the
coordinator who
completed the visit.
Dec-22-2020 02:29:35 ACV0PFEINFP6000 Query 1: Opened IVRS Reconciliation:
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901871
Page 172 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)BLIND BROKEN? is
‘No’ in Impala but
Treatment Unblinded
form is entered in
Inform. Please review
and update data as
appropriate. Else,
clarify. Thank you.
Dec-21-2020 17:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHER
If other, specify:
Patient reported pregnancy, she
withdrew so she could be unbli
ndedInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901872
Page 173 of 174
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-12-2021 16:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Jan-05-2021 12:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-07-2020 08:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020 12:59:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-14-2020 12:52:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-12-2021 16:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/21/2020Changed Information
Jan-05-2021 12:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/21/2020Initial Entry
Oct-07-2020 08:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-14-2020 12:59:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020 12:52:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901873
Page 174 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-16-2020 09:34:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e11\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901874