Document text
Page 1 of 231
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987975
Page 2 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987976
Page 3 of 231
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12031026]
2.Birth Date: UNK/UNK/1997
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987977
Page 4 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987978
Page 5 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987979
Page 6 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987980
Page 7 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987981
Page 8 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987982
Page 9 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [97.6]
3.Unit: kg
4.Height: [176.0]
5.Unit: cm
6.Body Mass Index: [31.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987983
Page 10 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [110623]
3.Randomization Group: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987984
Page 11 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HKV]
5.bSample ID [BN8HKW]
5.cSample ID [BNLM00]
5.dSample ID [BNLM01]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987985
Page 12 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8H8D]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987986
Page 13 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/20/2020 12:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987987
Page 14 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987988
Page 15 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987989
Page 16 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987990
Page 17 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987991
Page 18 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987992
Page 19 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987993
Page 20 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BN1BCZ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987994
Page 21 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/10/2020 09:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987995
Page 22 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987996
Page 23 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987997
Page 24 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987998
Page 25 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987999
Page 26 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/8/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8HFF]
5.bSample ID [BN8HFG]
5.cSample ID [BNLM46]
5.dSample ID [BNLM47]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988000
Page 27 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988001
Page 28 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988002
Page 29 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988003
Page 30 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988004
Page 31 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988005
Page 32 of 231
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988006
Page 33 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988007
Page 34 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988008
Page 35 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988009
Page 36 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988010
Page 37 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Iden
tifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 headache Nov/7/2020
16:00 NO
End Date Time:
Nov/7/2020 17:00
Repeating
Pages
2.ADVERSE
EVENT 2 inguinal her
nia left Nov/9/2020
16:00 NO
End Date Time:
Feb/19/2021 08:00
Repeating
Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988011
Page 38 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[headache]
4.Start Date Time: Nov/7/2020 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/7/2020 17:00
6.Toxicity Grade: 2
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988012
Page 39 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[stress induced]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988013
Page 40 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988014
Page 41 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[inguinal hernia left]
4.Start Date Time: Nov/9/2020 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/19/2021 08:00
6.Toxicity Grade: 2
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988015
Page 42 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital
anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong
hospitalization?
YES
Did this serious event result in persistent or
significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988016
Page 43 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE Comments
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021143222]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988017
Page 44 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988018
Page 45 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988019
Page 46 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988020
Page 47 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: //
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988021
Page 48 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988022
Page 49 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988023
Page 50 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988024
Page 51 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988025
Page 52 of 231
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988026
Page 53 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988027
Page 54 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988028
Page 55 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988029
Page 56 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/2/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [subject was called since he reported inguinal hernia with
planned surgery on 09FeB2021 3rd vaccination was planned to
01MAR2021]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988030
Page 57 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988031
Page 58 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988032
Page 59 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/10/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Information was given that surgery for inguinal hernia was
performed on 09FEB2021 including 1 overnight stay at surgery
site, ConMed: Ibuprofen 400mg 3x/day starting 09FEB2021, AE
onset corrected]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988033
Page 60 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988034
Page 61 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988035
Page 62 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/11/2021
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [further questions abaout start date of AE due to contradicting
information]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988036
Page 63 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988037
Page 64 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988038
Page 65 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988039
Page 66 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988040
Page 67 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988041
Page 68 of 231
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988042
Page 69 of 231
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988043
Page 70 of 231
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988044
Page 71 of 231
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988045
Page 72 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988046
Page 73 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent
Date :Not Applicable
//Comments
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988047
Page 74 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988048
Page 75 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988049
Page 76 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/1/2021
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988050
Page 77 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988051
Page 78 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988052
Page 79 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN1BJP]
5.bSample ID [BN1BJR]
5.cSample ID [BNLM8R]
5.dSample ID [BNLM8S]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988053
Page 80 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN1BM9]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988054
Page 81 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/1/2021 10:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988055
Page 82 of 231
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988056
Page 83 of 231
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988057
Page 84 of 231
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988058
Page 85 of 231
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988059
Page 86 of 231
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988060
Page 87 of 231
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988061
Page 88 of 231
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988062
Page 89 of 231
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988063
Page 90 of 231
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988064
Page 91 of 231
***Confidential***
Header Text: C4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988065
Page 92 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/8/2020
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988066
Page 93 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988067
Page 94 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sybille
Baumann Approved Mar-02-2021 18:00:44 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, SybilleBaumann, 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.
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988068
Page 95 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-20-2020 10:14:19 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988069
Page 96 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-20-2020 10:20:41 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988070
Page 97 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
10Feb-10-2021 15:28:46 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebDrug for Vaccination 3 temporarily
withdrawn or withheld
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988071
Page 98 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-03-2021 12:43:08
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988072
Page 99 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-03-2021 12:43:08 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988073
Page 100 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormFeb-03-2021 12:43:26
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988074
Page 101 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Feb-03-2021 12:43:26 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988075
Page 102 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormMar-01-2021 11:23:43
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebNot Applicable
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988076
Page 103 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sybille
Baumann Approved Mar-02-2021 18:00:44
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, SybilleBaumann, 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 Mar-01-2021 11:22:59
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Sybille
Baumann Approved Feb-17-2021 16:30:40
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988077
Page 104 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SybilleBaumann, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-15-2021 14:59:08
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Sybille
Baumann Approved Feb-12-2021 11:03:47
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988078
Page 105 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SybilleBaumann, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-10-2021 12:48:01
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Sybille
Baumann Approved Feb-04-2021 16:56:51
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988079
Page 106 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SybilleBaumann, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-03-2021 07:53:49
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Sybille
Baumann Approved Dec-11-2020 18:15:48
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988080
Page 107 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, SybilleBaumann, 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-08-2020 13:08:53
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-17-2020 17:14:03
(UTC+01:00) Sarajevo, Skopje,
Warsaw, ZagrebBOOK Signed
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988081
Page 108 of 231
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988082
Page 109 of 231
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-02-2020
13:52:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
08 SEP 2020Transcription
Error
Oct-20-2020
09:52:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-20-2020
09:52:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988083
Page 110 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-20-2020
09:52:34
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Oct/20/2020Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988084
Page 111 of 231
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-20-2020
09:52:09
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12031026Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-20-2020
11:43:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Transcription
Error
Oct-20-2020
09:52:06
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1997Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-20-2020
09:53:24
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988085
Page 112 of 231
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo, Skopje,
Warsaw, Zagreb
4. Ethnicity:
Date Location User Value Reason
Oct-20-2020
09:53:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-20-2020
09:53:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988086
Page 113 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
10:14:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988087
Page 114 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-20-2020
10:14:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
10:14:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
10:14:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988088
Page 115 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-20-2020
10:15:08
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988089
Page 116 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
97.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988090
Page 117 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
176.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.5Initial Entry
7.a
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988091
Page 118 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo, Skopje,
Warsaw, Zagrebntifier::
Temperatu
re:37.0
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988092
Page 119 of 231
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-20-2020
10:15:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988093
Page 120 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-20-2020
10:16:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-20-2020
10:16:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
110623Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988094
Page 121 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
13:23:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
13:23:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
13:23:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
13:23:18ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988095
Page 122 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebYes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
13:23:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
13:23:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN8HK
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
13:23:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8HKVInitial Entry
5.b
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988096
Page 123 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Oct-20-2020
13:23:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample I
D:BN8HK
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
13:23:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8HKWInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020
13:24:09
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BNLM0
0Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988097
Page 124 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
13:24:09
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLM00Initial Entry
5.d
Date Location User Value Reason
Oct-20-2020
13:24:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BNLM0
1Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-20-2020
13:24:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLM01Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988098
Page 125 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
13:24:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
13:24:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020
13:24:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
13:24:41ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988099
Page 126 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebYes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
13:24:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
13:24:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN8H8
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
13:24:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8H8DInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988100
Page 127 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988101
Page 128 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/20/2020 12:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988102
Page 129 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-20-2020
13:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988103
Page 130 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-20-2020
13:25:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988104
Page 131 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020
11:34:49
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-12-2020
15:18:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answere
din e-Diary as
of
12NOV2020
15:18 no
severe reaction
is present for
this subject
Nov-12-2020
15:06:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened the patient
reported a
severe reaction
on Nov.11th: is
an unplanned
assessment or
telehealth visit
going to be
performed?
Nov-10-2020
14:04:30
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988105
Page 132 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988106
Page 133 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988107
Page 134 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988108
Page 135 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NO
2.c Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-10-2020
14:05:02ACV0PFEINFP6000 Data Entry:
Symptom:: CInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988109
Page 136 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebHI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
O
2.d Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988110
Page 137 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988111
Page 138 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988112
Page 139 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988113
Page 140 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988114
Page 141 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988115
Page 142 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988116
Page 143 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988117
Page 144 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988118
Page 145 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988119
Page 146 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were injectio
n site reaction
s present on t
he last day th
e Subject Diar
y was complet
ed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-10-2020
14:05:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988120
Page 147 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2.a
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.6
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988121
Page 148 of 231
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo, Skopje,
Warsaw, Zagreb
2.a Temperature:
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-10-2020
14:05:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988122
Page 149 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020
14:05:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020
14:05:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020
14:05:45
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-10-2020
14:05:27ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988123
Page 150 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebYes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-10-2020
14:05:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020
14:05:45
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN1BC
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020
14:05:45
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN1BCZInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988124
Page 151 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988125
Page 152 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/10/2020 09:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988126
Page 153 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-10-2020
14:06:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988127
Page 154 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-08-2020
13:08:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988128
Page 155 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988129
Page 156 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988130
Page 157 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.b Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988131
Page 158 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NO
2.c Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-08-2020
13:10:40ACV0PFEINFP6000 Data Entry:
Symptom:: CInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988132
Page 159 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebHI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
O
2.d Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988133
Page 160 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988134
Page 161 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988135
Page 162 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.f Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988136
Page 163 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988137
Page 164 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988138
Page 165 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.h Symptom:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988139
Page 166 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988140
Page 167 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988141
Page 168 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988142
Page 169 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Were injectio
n site reaction
s present on t
he last day th
e Subject Diar
y was complet
ed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-08-2020
13:10:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988143
Page 170 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-08-2020
13:09:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-08-2020
13:09:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-08-2020
13:09:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-08-2020
13:09:15ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988144
Page 171 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebYes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-08-2020
13:09:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
Date Location User Value Reason
Dec-08-2020
13:09:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN8HF
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-08-2020
13:09:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8HFFInitial Entry
5.b
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988145
Page 172 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Dec-08-2020
13:09:43
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN8HF
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-08-2020
13:09:43
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8HFGInitial Entry
5.c
Date Location User Value Reason
Dec-08-2020
13:09:56
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BNLM4
6Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988146
Page 173 of 231
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.c Sample ID
Date Location User Value Reason
Dec-08-2020
13:09:56
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLM46Initial Entry
5.d
Date Location User Value Reason
Dec-08-2020
13:10:04
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BNLM4
7Initial Entry
5.d Sample ID
Date Location User Value Reason
Dec-08-2020
13:10:04
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNLM47Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988147
Page 174 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988148
Page 175 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988149
Page 176 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-12-2020
11:06:06
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-11-2020 ACV0PFEINFP6000 Query 1: Answe headache was
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988150
Page 177 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
15:59:07
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
Zagrebred induced to stress
at university,
thus a COVID 19
illness visit was
not indicated in
the opinion of
the investigator
Nov-11-2020
15:53:45
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Query 1: Opene
dCLINQUERY-
Nausea/fatigue
/headache/nasal
congestion/runny
nose may
represent a
potential
COVID-19
symptom, please
consider whether
a COVID-19
illness visit may
be indicated.
Thank you
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988151
Page 178 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/7/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/7/2020 17:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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).
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988152
Page 179 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
stress inducedInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988153
Page 180 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988154
Page 181 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020
14:08:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988155
Page 182 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-24-2021
20:53:19
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle Castillo Query 1: Closed Thank you for
the
confirmation.
Feb-17-2021 ACV0PFEINFP6000 Query 1: Answer after further
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988156
Page 183 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
09:32:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagrebed clarification
subject stated
that symptom
onset was on
9thNovember,
Follow-UP
SAE report has
already been
sent to safety
board,
physician
consultation
was on
16NOV2020
and in Jan2021,
hospitalization
was on
09FEB2021
Feb-16-2021
21:02:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle Castillo Query 1: Opened CLINICAL_
Per report,
"adverse event
symptom onset
was on
22Dec2020".
Pls clarify
symptom of
onset and if the
subject went to
ED/was
hospitalized on
that date.
Thanks.
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988157
Page 184 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
inguinal hernia le
ftInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-15-2021
15:04:19
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/9/2020 16:00Changed
Information
Feb-12-2021
16:39:43
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed as discussed
with SI today
site will wait
for hospital
record to be
sure about the
start date of
the SAE
Feb-12-2021
13:39:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened discrepancy:
per info
documented on
11Feb21 in
source
symptoms
started on
9Nov2021
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988158
Page 185 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/22/2020 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021
20:16:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-01-2021
12:45:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New
Information
Mar-01-2021
12:45:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/19/2021 08:
00New
Information
Feb-26-2021
21:40:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please confirm
if "inguinal
hernia left"
remains
ongoing (start
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0988159
Page 186 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov 09, 2020).
Else, review if
update can be
applied to end
date and
outcome status.
Thank you
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 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
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988160
Page 187 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-17-2021
02:15:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-11-2021
22:03:25
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-11-2021
08:08:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edAnswer Auto
Query
Feb-11-2021
08:08:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NOTranscription
Error
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988161
Page 188 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or sign
ificant disability
/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important seriou
s event
NO
Feb-11-2021
06:44:47
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Reissue
d:OpenedDM: Kindly
consider to tick
all the
seriousness
criteria's
reported in
CRF field.
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988162
Page 189 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Thank you.
Feb-10-2021
15:25:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Answer
edEvent is serious
due to required
surgery with
hospitalization
for 1 night
Feb-10-2021
15:23:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?'
is reported
'Yes', but at
least one
seriousness
criteria is
missing. Please
review and
update as
appropriate.
Feb-10-2021
15:23:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE
inguinal hernia
left: Response
to "Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-10-2021
15:23:58ACV0PFEINFP6000 Data Entry:
YESChanged
Information
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988163
Page 190 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebDid this serious
event require or
prolong hospital
ization?
YES
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988164
Page 191 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-11-2021
21:19:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response
satisfies query
Feb-11-2021
15:38:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edTranscription
Error
Feb-11-2021
15:38:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICAB
LETranscription
Error
Feb-11-2021
13:53:56
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Blinded
treatment phase
is complete and
open label
phase has not
yet started (vax
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0988165
Page 192 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
3 not yet
given). As
such, please
review this
entry.
Temporary
delays are not
classified as
'drug
withdrawn'
Feb-10-2021
15:28:04
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
DRUG WITHDR
AWNChanged
Information
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-10-2021
15:29:25
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESChanged
Information
Feb-10-2021
12:48:01ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988166
Page 193 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagreb
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-10-2021
15:26:00
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESChanged
Information
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-01-2021
12:46:13
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Cl
osedClose Auto Query
Mar-01-2021
12:46:13
(UTC+01:00)ACV0PFEINFP6000 Data Entry
:
RECOVERNew Information
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988167
Page 194 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo,
Skopje,
Warsaw,
ZagrebED/RESOL
VED
Mar-01-2021
12:45:31
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Op
enedFor AE inguinal hernia
left: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Feb-10-2021
15:29:05
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data Entry
:
RECOVERI
NG/RESOL
VINGChanged Information
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data Entry
:
NOT RECO
VERED/NO
T RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988168
Page 195 of 231
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-10-2021
12:48:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-17-2021
02:15:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
2021143222Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0988169
Page 196 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
07:53:48
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988170
Page 197 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Feb-03-2021
07:56:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
07:53:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Feb-03-2021
07:53:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CONTACT OUTCO
MEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988171
Page 198 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-03-2021
07:56:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-03-2021
07:56:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/2/2021
Contact Outcome:
VISIT NOT REQ
UIRED, INVESTI
GATOR DECISIO
NInitial Entry
3. Comments:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988172
Page 199 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled
Visit on Feb/02/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-03-2021
07:56:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
subject was called sin
ce he reported inguina
l hernia with planned
surgery on 09FeB202
1 3rd vaccination was
planned to 01MAR20
21Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988173
Page 200 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
15:30:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/10/2021Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988174
Page 201 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Feb-10-2021
15:32:34
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
15:30:46
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Contact
Outcome is
ticked
however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Feb-10-2021
15:30:46
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CONTACT OUT
COMEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988175
Page 202 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-10-2021
15:32:34
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-10-2021
15:32:34
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/10/2021
Contact Outcome:
VISIT NOT RE
QUIRED, INVE
STIGATOR DE
CISIONInitial Entry
3. Comments:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988176
Page 203 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 2 - Unscheduled
Visit on Feb/10/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-10-2021
15:32:34
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Information was giv
en that surgery for i
nguinal hernia was
performed on 09FE
B2021 including 1
overnight stay at su
rgery site, ConMed:
Ibuprofen 400mg 3
x/day starting 09FE
B2021, AE onset co
rrectedInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988177
Page 204 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021
14:59:07
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988178
Page 205 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Assessments
Date Location User Value Reason
Feb-15-2021
15:01:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-15-2021
14:59:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Feb-15-2021
14:59:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CONTACT OUTCO
MEInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988179
Page 206 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-15-2021
15:01:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-15-2021
15:01:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/11/2021
Contact Outcome:
VISIT NOT REQ
UIRED, INVESTI
GATOR DECISIO
NInitial Entry
3. Comments:
Date Location User Value Reason
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988180
Page 207 of 231
***Confidential***
Header Text: C4591001
Visit: Unplanned 3 - Unscheduled
Visit on Feb/11/2021Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-15-2021
15:01:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
further questions abao
ut start date of AE du
e to contradicting info
rmationInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988181
Page 208 of 231
***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, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-08-2020
13:10:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-08-2020
13:10:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-08-2020
13:10:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988182
Page 209 of 231
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
12:43:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988183
Page 210 of 231
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021
12:43:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible per other
protocol allowan
ce(s) and confir
med to have rece
ived only placeb
o at Vaccination
1/2Initial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988184
Page 211 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021
12:42:49
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021
12:42:49
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988185
Page 212 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-03-2021
12:43:08
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988186
Page 213 of 231
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-03-2021
12:43:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0988187
Page 214 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
11:22:59
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988188
Page 215 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-01-2021
11:23:17
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written
Consent Obtai
ned
Mar/1/2021Initial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988189
Page 216 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-01-2021
11:24:44
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial
Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-01-2021
11:24:44
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENIN
G 1Initial Entry
3. Status:
Date Location User Value Reason
Mar-01-2021
11:24:44
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988190
Page 217 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
11:25:03
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
11:25:03
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
11:25:29
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Dele
tedClose Auto
Query
Mar-01-2021 ACV0PFEINFP6000 auto query Query 1: Can 'Sample
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988191
Page 218 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11:25:03
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
Zagreb(autoquery) didate Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
11:25:03
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Coll
ection:
Mar/1/202
1Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
11:25:29
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Sample
ID:BN1
BJPInitial
Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
11:25:29
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
BN1BJPInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988192
Page 219 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo,
Skopje, Warsaw,
Zagreb
5.b
Date Location User Value Reason
Mar-01-2021
11:25:45
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Sample
ID:BN1
BJRInitial
Entry
5.b Sample ID
Date Location User Value Reason
Mar-01-2021
11:25:45
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
BN1BJRInitial
Entry
5.c
Date Location User Value Reason
Mar-01-2021
11:26:05
(UTC+01:00)
Sarajevo,ACV0PFEINFP6000 Data Entry:
Sampl
e ID:BNL
M8RInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988193
Page 220 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Skopje, Warsaw,
Zagreb
5.c Sample ID
Date Location User Value Reason
Mar-01-2021
11:26:05
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
BNLM8RInitial
Entry
5.d
Date Location User Value Reason
Mar-01-2021
11:26:22
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Sample
ID:BNL
M8SInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988194
Page 221 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.d Sample ID
Date Location User Value Reason
Mar-01-2021
11:26:22
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
BNLM8SInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988195
Page 222 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
11:26:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
11:26:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
11:27:26
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Dele
tedClose Auto
Query
Mar-01-2021 ACV0PFEINFP6000 auto query Query 1: Can 'Sample
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988196
Page 223 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11:26:57
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
Zagreb(autoquery) didate Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
11:26:57
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Coll
ection:
Mar/1/202
1Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
11:27:26
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Sample
ID:BN1B
M9Initial
Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
11:27:26
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
BN1BM9Initial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988197
Page 224 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Sarajevo,
Skopje, Warsaw,
Zagreb
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988198
Page 225 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
NOInitial
Entry
2. Treatment Name
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988199
Page 226 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
Mar/1/2021 10:
41Initial
Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial
Entry
7. Route:
Date Location User Value Reason
Mar-01-2021
11:31:18ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988200
Page 227 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagreb
8. Actual Dose:
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0988201
Page 228 of 231
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
investigational product administration?
Date Location User Value Reason
Mar-01-2021
11:31:18
(UTC+01:00)
Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000 Data Entry:
YESInitial
Entry
090177e196ae3f12\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0988202
Page 229 of 231
***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: 1203 Site Name: (1203) CRS Clinical Research Services Berlin
Subject No: 12031026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location Us
…[truncated]