Document text
Category
Date
T me
PID
Protoco Vers on
Was the subject re screened?
A prev ous TSNs (e.g. 276 0 234)
Date of f rst Informed ConsentInformed Consent (2.1)
No YesBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
DS=Disposition
DM=Demographics
DSCAT='PROTOCOL MILESTONE'
DSSTDTC
Page 1
SUPPDS.QVAL when QNAM = 'PREV_TSN'
DSSTDTC
SUPPDS.QVAL when QNAM = 'PROTVERS'
[NOT SUBMITTED]
RFICDTC
DSTERM/DSDECOD='INFORMED CONSENT OBTAINED'
DSTERM/DSDECOD='FIRST INFORMED CONSENT OBTAINED'
SUBJID
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058202
Age
Sex
Race,
select all that apply
If Other, p ease spec fy
Ethn c tyDemographic Data (2.1)
years
months
Ma e
Fema e
Wh te
B ack or Afr can Amer can
As an
Amer can Ind an or A aska Nat ve
Nat ve Hawa an or Other Pac f c Is ander
Not reported
Unknown
Other
Not H span c or Lat no
H span c or Lat no
Not reported
UnknownBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
DM=Demographics
AGEU='YEARS'
AGE
SEX
RACE
If more than one option is selected:
RACE = 'MULTIPLE', and individual responses
in SUPPDM with QNAM = 'RACE1', 'RACE2',...
SUPPDM.QVAL when
QNAM='RACEOTH'
ETHNIC
SUPPDM.QVAL when
QNAM='AGE_M'
Page 2
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058203
Body Height/Weight + BMI (2.0)
Not doneReason not done Date T me He ght
(cm)We ght
(kg) Body Mass Index
(kg/m²)BMI (ca cu ated)
(kg/m²)
More rows: 5 0
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
VS=Vital Signs
VSSTAT='NOT DONE'
when VSTESTCD='VSALL'
VSREASND
VSDTC
VSTEST
VSTEST
VSORRESU/
VSORRES
when
VSTESTCD=
'HEIGHT'
VSTEST
[NOT SUBMITTED]
Page 3
VSORRESU/
VSORRES
when
VSTESTCD=
'WEIGHT'
VSORRESU/
VSORRES
when
VSTESTCD=
'BMI'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058204
Reproduct ve Test
Ch dbear ng potent a
Non ch dbear ng potent a
Date of Last menses
Date of Ster zat on
Other , please specifyChildbearing Potential (2.0)
No Yes NA
Postmenopausa (>= 2 months)
Surg ca y ster zed
OtherBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
RP=Reproductive System Findings
RPORRES when RPTESTCD='CHILDPOT'
RPTEST='Childbearing Potential'
[NOT SUBMITTED]
RPTEST='Reason for Non-
childbearing potential'
RPTEST='Date of Sterilization'
RPTEST='Last Menstrual Period Start Date'
SUPPRP.QVAL when QNAM='OTH_SPEC'
Page 4
RPORRES when
RPTESTCD='NON_REAS'
RPORRES when RPTESTCD='LMPSTDTC'
RPORRES when RPTESTCD='STER_DTC'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058205
Urine Pregnancy Test (2.0)
Category
Spec menNA Not done Reason not done Date T me Resu t
Negat ve
Pos t ve
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
LB=Laboratory Test Results
LBTEST='Choriogonadotropin Beta'
LBCAT='CHEMISTRY'
LBSTAT='NOT DONE'
LBREASND
LBDTC
LBORRES when LBTESTCD='HCG'
[NOT SUBMITTED]
LBSPEC
LBSCAT='PREGNANCY'
Page 5
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058206
Not done
Reason not done
Date
T mePhysical Examination (2.1)
System/Organ Norma /Abnorma /ND Abnorma t es/Symptoms C n ca S gn f cance
F nd ng (ca cu ated)
Genera cond t on/psyche Norma Abnorma ND NCS CS
2
Sk n Norma Abnorma ND NCS CS
3
Lymph nodes Norma Abnorma ND NCS CS
4
Head (eyes, ears, mouth) Norma Abnorma ND NCS CS
5
Neck/thyro d g and Norma Abnorma ND NCS CS
6
Lungs Norma Abnorma ND NCS CS
7
Heart Norma Abnorma ND NCS CS
8
Abdomen Norma Abnorma ND NCS CS
9
Muscu oske eta system Norma Abnorma ND NCS CS
0
Neuro og ca system Norma Abnorma ND NCS CS
Vascu ar system Norma Abnorma ND NCS CS
2
Card ovascu ar Norma Abnorma ND NCS CS
3
Gastro ntest na Norma Abnorma ND NCS CS
4
Other Norma Abnorma ND NCS CSBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
PE=Physical Examination
PECAT='GENERAL'
PESTAT='NOT DONE' when PETESTCD='HEALTHY'
PEREASND
PEDTC
PESPID
PETEST
PEORRES
[NOT SUBMITTED]
PEORRES when...
[NOT SUBMITTED]
SUPPPE.QVAL='N'
when
QNAM='PECLSIG'
SUPPPE.QVAL='Y'
when
QNAM='PECLSIG'
Page 6
...PETESTCD='GENCON'
...PETESTCD='SKIN'
...PETESTCD='LYMPHN'
...PETESTCD='HEAD'
...PETESTCD='NECK'
...PETESTCD='LUNGS'
...PETESTCD='HEART'
...PETESTCD='ABDOMEN'
...PETESTCD='MUSCULO'
...PETESTCD='NEUROL'
...PETESTCD='VASCUL'
...PETESTCD='CARDVASC'
...PETESTCD='GASTRO'
...PETESTCD='OTHER'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058207
Vital Signs incl. VSTPT (2.0)
No
do eReaso o do e Da e e Measu e e
pos o (B )Measu e e
s de (A )Sys o c B ood
ess e
( Hg)C ca
S g f ca ceD as o c B ood
essu e
( Hg)C ca
S g f ca cese Ra e
(bea s/ ) C ca
S g f ca ceResp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1R g Lef NCS CS NCS CS NCS CS NCS CS
Please insert as many new rows as needed for the according visits and use "Schedule ired (attention BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
VS=Vital Signs
VSSTAT='NOT DONE'
when
VSTESTCD='VSALL'
VSREASND
VSDTC
VSPOS
VSLOC
VSLAT
VSORRESU
/VSORRES
when
VSTESTCD
='SYSBP'
VSTEST
VSTEST
VSTEST
For NCS:
SUPPVS.QVAL='N'
when
QNAM='VSCLSIG'
For CS:
SUPPVS.QVAL='Y'
when
QNAM='VSCLSIG'
VSTEST
Page 7
VSORRESU
/VSORRES
when
VSTESTCD
='DIABP'
VSORRESU
/VSORRES
when
VSTESTCD
='PULSE'
VSORRESU
/VSORRES
when
VSTESTCD
='RESP'
VSTPT
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058208
Body Temperature (2.1)
Not doneReason not done Date T me Measurement s te
Other measurement s te, spec fy:Body Temperature
(°C)C n ca S gn f cance
NCS CS
5 0
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
VS=Vital Signs
VSSTAT=
'NOT
DONE'
VSREASND
VSDTC
VSLOC
Page 8
VSORRESU
/VSORRES
when
VSTESTCD
='TEMP'
For NCS:
SUPPVS.QVAL='N'
when
QNAM='VSCLSIG'
For CS:
SUPPVS.QVAL='Y'
when
QNAM='VSCLSIG'
VSTEST='Temperature'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058209
12-lead ECG (2.0)
No
do eReaso o do e Da e e Measu e e
pos oHea Ra e
(bea s/ )I e p e a o C ca
S g f ca ceF d gs,
select all that
apply
1No a Ab o a NCS CS
Pl
ease insert new row(s), if you are in visit "Unscheduled Forms" onBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
EG=ECG Test Results
EGMETHOD='12 LEAD STANDARD'
EGSTAT='NOT DONE'
when
EGTESTCD='EGALL'
EGREASND
EGDTC
EGPOS
For NCS:
SUPPEG.QVAL='N'
when
QNAM='EGCLSIG'
For CS:
SUPPEG.QVAL='Y'
when
QNAM='EGCLSIG'
SUPPEG.QVAL when QNAM='CODE'
EGORRES
when
EGTESTCD=
'INTP'
Page 9
EGORRESU/
EGORRES
when
EGTESTCD=
'EGHRMN'
EGCAT='MEASUREMENT'
EGCAT='FINDING'
EGTEST='ECG
Mean Heart Rate'
EGTEST
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058210
Urine Drug Screen (2.0)
Ca ego y Spec e No
do eReaso o do e Da e e Me a p e a es Op a es Coca e Ca ab o ds e cyc d e Be zod azep es Ba b u a es Me ado e cyc c
a dep essa sA p e a es
1 Nega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os veNega ve
os ve
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
LB=Laboratory Test Results
LBCAT='URINALYSIS'
LBSCAT='DRUG OF ABUSE'
LBREASND
LBSPEC
LBTEST
LBDTC
Page 10
LBSTAT='NOT DONE'
when
LBTESTCD='LBALL'
LBORRES
when
LBTESTCD=
'METHAMPH'
LBORRES
when
LBTESTCD
='OPIATE'
LBORRES
when
LBTESTCD=
'COCAINE'
LBORRES
when
LBTESTCD
='CANNAB'
LBORRES
when
LBTESTCD=
'PCP'
LBORRES
when
LBTESTCD=
'BNZDZPN'
LBORRES
when
LBTESTCD=
'BARB'
LBORRES
when
LBTESTCD=
'METHDN'
LBORRES
when
LBTESTCD=
'TRCYANDP'
LBORRES
when
LBTESTCD=
'AMPHET'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058211
Alcohol Breath Test (2.0)
Category Spec men Not done Reason not done Date T me Resu t
Negat ve
Pos t ve
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
LB=Laboratory Test Results
LBTEST='Ethanol'
LBSPEC='EXPIRED AIR'
LBCAT='CHEMISTRY'
LBSCAT='DRUG OF ABUSE'
LBSTAT=
'NOT
DONE'
LBREASND
LBDTC
LBORRES when
LBTESTCD='ETHANOL'
Page 11
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058212
Urine Sampling for Urinalysis (2.0)
Category Spec men Not done Reason not done Date T me
Al
l comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
LB=Laboratory Test Results
LBSPEC='URINE'
LBCAT='URINALYSIS'
LBSTAT='NOT DONE'
when
LBTESTCD='LBALL'
LBREASND
LBDTC
Page 12
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058213
Blood Samples for Safety Lab (2.0)
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH at Visit 0
Category Spec men Not done Reason not done Date T me Fast ng?
No Yes
More rows: 5 0
All comments will be ente
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
LB=Laboratory Test Results
LBSTAT='NOT DONE'
when LBTESTCD='LBALL'
LBREASND
LBDTC
LBFAST
MB=Microbiology Specimen
MBSTAT='NOT DONE'
when MBTESTCD='MBALL'
MBREASND
MBDTC
Page 13
MBCAT='SARS-CoV-2 Antibodies'
MBCAT='SEROLOGY'
LBSPEC
LBCAT
MBCAT
MBSPEC
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058214
Subject meets a nc us on cr ter a and does
not meet any exc us on cr ter a?
DateIn-/Exclusion Criteria (2.0)
No Yes
If No, p ease se ect a v o ated
In /Exc us on cr ter a:
Inc us on Cr ter a:
Exc us on Cr ter a:
BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
IE=Inclusion/Exclusion Criteria Not Met
[NOT SUBMITTED]
IEDTC
IECAT='INCLUSION'
IECAT='EXCLUSION'
IEORRES='N' when
IETESTCD='INxx'
Page 14
IEORRES='Y' when
IETESTCD='EXxx'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058215
Not done
Reason not done
Date
T me
Overa hea th judgement subject hea thy?Physical Examination (2.1)
No Yes
System/Organ Norma /Abnorma /ND Abnorma t es/Symptoms C n ca S gn f cance
F nd ng (ca cu ated)
Genera cond t on/psyche Norma Abnorma ND NCS CS
2
Sk n Norma Abnorma ND NCS CS
3
Lymph nodes Norma Abnorma ND NCS CS
4
Head (eyes, ears, mouth) Norma Abnorma ND NCS CS
5
Neck/thyro d g and Norma Abnorma ND NCS CS
6
Lungs Norma Abnorma ND NCS CS
7
Heart Norma Abnorma ND NCS CS
8
Abdomen Norma Abnorma ND NCS CS
9
Muscu oske eta system Norma Abnorma ND NCS CS
0
Neuro og ca system Norma Abnorma ND NCS CS
Vascu ar system Norma Abnorma ND NCS CS
2
Card ovascu ar Norma Abnorma ND NCS CS
3
Gastro ntest na Norma Abnorma ND NCS CS
4
Other Norma Abnorma ND NCS CSBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
PE=Physical Examination
PECAT='GENERAL'
PEDTC
PESPID
PETEST
PEORRES
[NOT SUBMITTED]
[NOT SUBMITTED]
SUPPPE.QVAL='N'
when
QNAM='PECLSIG'
SUPPPE.QVAL='Y'
when
QNAM='PECLSIG'
PESTAT='NOT DONE' when PETESTCD='HEALTHY'
PEREASND
PEORRES when PETESTCD='HEALTHY'
Page 15
PETEST='Overall Health Judgement-Subj. healthy?'
PEORRES when...
...PETESTCD='GENCON'
...PETESTCD='SKIN'
...PETESTCD='LYMPHN'
...PETESTCD='HEAD'
...PETESTCD='NECK'
...PETESTCD='HEART'
...PETESTCD='LUNGS'
...PETESTCD='ABDOMEN'
...PETESTCD='MUSCULO'
...PETESTCD='NEUROL'
...PETESTCD='VASCUL'
...PETESTCD='CARDVASC
...PETESTCD='GASTRO'
...PETESTCD='OTHER'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058216
Oral Swipe for SARS-CoV-2 Testing (2.1)
Category Spec men Not done Reason not done Date T me Test name Resu t
Negat ve
Pos t ve
More rows: 5 0
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
MB=Microbiology Specimen
MBREASND
MBSTAT
='NOT
DONE'
MBDTC
MBORRES
when
MBTESTCD=
'SARSCOV2'
MBTSTDTL='DETECTION'
MBSPEC=
'SWABBED
MATERIAL'
MBLOC=
'ORAL CAVITY'
MBTEST='Severe Acute Resp
Syndrome Coronavirus 2'
MBMETHOD='QUANTITATIVE
REVERSE TRANSCRIPTASE
POLYMERASE CHAIN REACTION'
Page 16
MBCAT='SARS-CoV-2 Test (Oral Swipe)'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058217
Category
Date
T me
Subject s a ocated to
GroupAllocation (2.1)
[2]
[3]
Cohort [4]
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
Cohort 8
Cohort 9
Cohort 0
A (BNT 62a ) [5]
B (BNT 62b )
C (BNT 62b2)
D (BNT 62c2)
E (BNT 62c2 P/B)BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
DS=Disposition
DSTERM/DSDECOD='ALLOCATED'
DSCAT='PROTOCOL MILESTONE'
DSSTDTC
SUPPDS.QVAL when
QNAM = 'COHORT'
SUPPDS.QVAL when
QNAM = 'GROUP'
Page 17
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058218
Blood Samples for Immunogenicity (2.1)
Category Spec men Not done Reason not done Date T me
More rows: 5 0
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
IS=Immunogenicity Specimen Assessments
ISSTAT='NOT DONE'
when
ISTESTCD='ISALL'
ISREASND
ISDTC
ISSPEC=
'SERUM'
Page 18
ISCAT='IMMUNOGENICITY'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058219
Blood Samples for CMI (2.1)
Category Spec men Not done Reason not done Date T me
More rows: 5 0
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
[NOT SUBMITTED]
Page 19
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058220
Schedu ed t me
Not done
Reason not done
Other, spec fy
Date
T me
Route of Adm n strat on
Treatment
Med cat on Number
Dose Form
P anned dose
Other, spec fy
Un t
Tota Dose (Vo ume of Inject on)
Un t
Tota Dose g ven?
If No, rest vo ume
App cat on s te
Administration (2.1)
ug
ug
mL
No Yes
mL
r ght eft uppe armBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
EC=Exposure as Collected
EX=Exposure
ECSTDTC
EXSTDTC
ECROUTE
EXROUTE
ECTRT
EXTRT
[NOT SUBMITTED]
If 'Not Done'='No' then ECOCCUR='Y'
If 'Not Done'='Yes' then ECOCCUR='N'
SUPPEC.QVAL when
QNAM='MED_NO'
SUPPEX.QVAL when
QNAM='MED_NO'
ECDOSFRM
EXDOSFRM
ECDOSE
ECDOSU
EXDOSE if 'Total
Dose given?' is 'Yes'
EXDOSU
SUPPEC.QVAL when QNAM='TOTDOS'
SUPPEX.QVAL when QNAM='TOTDOS'
SUPPEC.QVAL when QNAM='RESTVOL'
SUPPEX.QVAL when QNAM='RESTVOL'
ECDIR
ECLOC
ECLAT
EXLAT
EXDIR
EXLOC
if ECOCCUR='N':
SUPPEC.QVAL when
QNAM='ECREASOC'
If 'Total Dose given?' is 'No' then
EXDOSE='Total Dose (Volume of
Injection)' - 'Rest Volume' * 'Planned
Dose' / 'Total Dose (Volume of Injection)'
Page 20
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058221
Adm n strat on accord ng to protoco ?
If No, p ease spec fy
Ep /Pandem c re ated adjustment
Ep /Pandem c re ated nterrupt onNo Yes
No Yes
No YesBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
SUPPEX.QVAL when QNAM='ADMPPROT'
SUPPEC.QVAL when QNAM='ADMPPROT'
SUPPEX.QVAL when QNAM='ADMNPPSP'
SUPPEC.QVAL when QNAM='ADMNPPSP'
SUPPEX.QVAL when QNAM='EXEPINTI'
SUPPEX.QVAL when QNAM='EXEPADJI'
SUPPEC.QVAL when QNAM='ECEPADJI'
Page 21
SUPPEC.QVAL when QNAM='ECEPINTI'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058222
Local Tolerability at Injection Site (2.1)
Ca ego y Sc edu ed e
No
do eReaso o do e Da e e es Na e Eva ua o I e s y of a I e s y of
e de essI e s y of
E y e a/Red essI e s y of
I du a o /Swe g
1
No e
M d
Mode a e
Seve e
o e a y fe
e
a e gNo e
M d
Mode a e
Seve e
o e a y fe
e
a e gNo e
M d
Mode a e
Seve e
o e a y fe
e
a e gNo e
M d
Mode a e
Seve e
o e a y fe
e
a e g
Mo e ows: 1 5 10
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
FACE=Findings About Clinical Events
FASCAT='ADMINISTRATION SITE'
FAREASND
FADTC
FAEVAL='INVESTIGATOR'
FAOBJ
FAORRES='N' when
FATESTCD='OCCUR'
[NOT SUBMITTED]
FAORRES
when
FATESTCD='SEV'
FASTAT='NOT DONE' when
FAOBJ='All Objects of the Observation'
Page 22
FACAT='REACTOGENICITY'
FAORRES='Y' when
FATESTCD='OCCUR'
FATEST='Severity/Intensity'
FATEST='Occurrence Indicator'
FATPT
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058223
Systemic Events Assessment
[1]
Category [2] Scheduled time
[3] Not
done
[4]Reason not done [5] Date [6] ime [7] est Name [8] Evaluator [9] Fever
[10]ntensity of
Headache
[11]New or
worsened
muscle pain
[12]New or
worsened joint
pain [13]ntensity of
Nausea
[14]ntensity of
Vomiting
[15]ntensity of
Diarrhea
[16]ntensity of
Chills
[17]ntensity of
Loss of
appetite
[18]ntensity of
Malaise
[19]Fatigue/ iredness
[20]
1
None
Mild
Moderate
Severe
Potentially
life
threateningNone
Mild
Moderate
Severe
Potentially
life
threateningNone
Mild
Moderate
Severe
Potentially
life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
More rows 1 5 10
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
FAORRES='N' when
FATESTCD='OCCUR'
FAOBJ
FAEVAL='INVESTIGATOR'
[NOT SUBMITTED]
FADTC
FAREASND
FASTAT='NOT DONE' when
FAOBJ='All Objects of the Observation'
FASCAT='SYSTEMIC'
FACE=Findings About Clinical Events
FAORRES
when
FATESTCD='SEV'
Page 23
FACAT='REACTOGENICITY'
FAORRES='Y' when
FATESTCD='OCCUR'
FATEST='Severity/Intensity'
FATEST='Occurrence Indicator'
FATPT
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058224
Phone Call (2.0)
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
NA Not done Reason not done Date T me Outcome of the ca (e.g. No f nd ngs or new AEs/CMs reported)
More rows: 5 0
Please document any additional information / changes in the appropriate forms!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
XA=Ancillary Analysis and Visit Details
XACAT='PHONE CALL'
XAORRES when XATESTCD='OUT_CALL'
XADTC
[NOT SUBMITTED]
XAORRES when
XATESTCD='ND'
when 'Yes'
XAORRES when
XATESTCD='REAS_ND'
Page 24
XATEST
XATEST
XATEST
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058225
Category
Tr a fu y comp eted?
Date of Comp et on or Ear y W thdrawa
Ma n Reason for premature term nat on
Date of Death
Other, spec fy:
Ep /Pandem c re ated
Date of ast v s t/contactEnd of Trial (2.1)
No Yes
Adverse Event
Death
Lost to Fo ow up
Phys c an Dec s on
Pregnancy
Protoco Dev at on
Screen Fa ure
S te Term nated by Sponsor
Study Term nated by Sponsor
Techn ca Prob ems
W thdrawa by Subject
Other
No YesBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
DS=Disposition
DM=Demographics
DSCAT='DISPOSITION EVENT'
DSDECOD='COMPLETED' when Yes
[NOT SUBMITTED]
DSSTDTC
DSTERM when DSDECOD is OTHER
[NOT SUBMITTED] for completer
DTHDTC
DSTERM when not Other
[Note: If Epi-Pandemic
related response is 'Yes',
" due to COVID-19" is
appended to DSTERM]
SUPPDS.QVAL when
QNAM = 'DSEPRELI'
SUPPDS.QVAL when
QNAM = 'LASTCONT'
for non-completer
DSSCAT='END OF TRIAL'
Page 25
DSTERM='END OF TRIAL COMPLETED' when Yes
DSDECOD
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058226
Category
Fo ow up fu y comp eted?
Date of Comp et on or Ear y W thdrawa
Ma n Reason for premature term nat on
Date of Death
Other, spec fy:
Ep /Pandem c re ated
Date of ast v s t/contactEnd of Follow-up (2.1)
No Yes
Adverse Event
Death
Lost to Fo ow up
Phys c an Dec s on
Pregnancy
Protoco Dev at on
Screen Fa ure
S te Term nated by Sponsor
Study Term nated by Sponsor
Techn ca Prob ems
W thdrawa by Subject
Other
No YesBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
see CRF page 25
DS=Disposition
DSDECOD = 'COMPLETED' when Yes
DSCAT='DISPOSITION EVENT'
DSSCAT='END OF FOLLOW-UP'
Page 26
DSTERM='END OF FOLLOW-UP COMPLETED' when Yes
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058227
Any Med ca H story?Medical History (2.0)
No Yes [1]
If Ongoing, please specify intensity (toxicity grading scale)
Abnorma ty/D sease [2] Start Date [3] End Date [4] Ongo ng [5]
No Yes
2 No Yes
3 No Yes
4 No Yes
5 No Yes
6 No Yes
7 No Yes
8 No Yes
9 No Yes
0 No Yes
More rows: 5 0BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
MH=Medical History
[NOT SUBMITTED]
MHTERM
MHSTDTC
MHENDTC
MHENRTPT=
'BEFORE'
MHENRTPT=
'ONGOING'
MHENTPT='SCREENING'
Page 27
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058228
Observation Period (2.0)
Vacc nat on V s t P anned observat on per od Other p anned observat on per od (e.g. 8 hours) Adherence to p anned observat on per od? If No, actua observat on per od
(hours)Reason
No Yes
More rows: 5 0
Please insert as many new rows as needed for the according visits!BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
XACAT='OBSERVATION PERIOD'
XAORRES when
XATESTCD='VACCIN_V'
XATPT
SUPPXA.QVAL when
QNAM = 'ACT_TPT'
SUPPXA.QVAL when
QNAM = 'REASON'
XA=Ancillary Analysis and Visit Details
Page 28
XATEST
VISIT
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058229
Diary - Local Reactions (2.1)
If any grading of any reaction is not NONE and not related to IMP, please document on Adverse Event page.
If any grading of any reaction is not NONE and related to IMP, please document as diagnosis on Adverse Event page.
Category [1] Study Day
[2] Not
done
Date [4] T me [5] Test Name
[6]Eva uator [7] Intens ty of Pa n
[8]Intens ty of
Tenderness [9]Intens ty of
Erythema/Redness [10]Intens ty of
Indurat on/Swe ng [11]
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
2
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngN
M d
Moderate
Severe
Potent a y fe
threaten ng
3
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
4
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
5
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
FACE=Findings About Clinical Events
FASCAT='ADMINISTRATION SITE'
FASTAT='NOT DONE'
when FAOBJ='All Objects
of the Observation'
FADTC
FAEVAL='STUDY SUBJECT'
FAOBJ='Injection site reaction - <reaction type>'
Page 29
CE=Clinical Events
CESCAT='ADMINISTRATION SITE'
CECAT='REACTOGENICITY'
FACAT='REACTOGENICITY'
FAORRES='N' when
FATESTCD='OCCUR'
FAORRES='Y' when
FATESTCD='OCCUR'
FAORRES when
FATESTCD='SEV'
CETERM='Injection site reaction - <reaction type>'
CEOCCUR='Y'
SUPPFACE.QVAL when
QNAM='STUDYDAY'
[NOT SUBMITTED]
FATEST='Severity/Intensity'
FATEST='Occurrence Indicator'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058230
6
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
7
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
8
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
9
None
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ngNone
M d
Moderate
Severe
Potent a y fe
threaten ng
More rows: 5 0BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
Page 30
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058231
Diary - Systemic Reactions (2.1)
If any grading of any reaction is not NONE and not related to IMP, or subject has fever [i.e., temperature is >= 38°C], please document on Adverse Event page.
If any grading of any reaction is not NONE and related to IMP, or subject has fever [i.e., temperature is >= 38°C], please document as diagnosis on Adverse Event Page.
ay
Not
done
[3]Date [4] Time [5]Test Name
[6]Evaluator [7] Body
Temperature
(°C) [8]Intensity of
eadache [9]Intensity of
Myalgia
[10]Intensity of
Arthralgia [11]Intensity of
Nausea
[12]Intensity of
Vomiting
[13]Intensity of
Diarrhea
[14]Intensity of
Chills
[15]Intensity of Loss
of appetite
[16]Intensity of
Malaise
[17]Intensity of
Fatigue
[18]
1
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
None
Mild
Potentially life
threateningNone
Mild
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Severe
Potentially life
threatening
3
Moderate
Severe
Potentially life
threateningModerate
Severe
Potentially life
threateningNo
Mil
Moderate
Severe
Potentially life
threateningModerate
Severe
Potentially life
threateningN
Mild
Moderate
Severe
Potentially life
threateningMild
Moderate
Severe
Potentially life
threateningMild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
4
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
5
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
6
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
7
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningBioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
FACE=Findings About Clinical Events
FASCAT='SYSTEMIC'
FAEVAL='STUDY SUBJECT'
SUPPFACE.QVAL when
QNAM='STUDYDAY'
FASTAT='NOT DONE'
when FAOBJ='All Objects
of the Observation'
FADTC
FAOBJ
VS=Vital Signs
VSORRESU/VSORRES when
VSTESTCD='TEMP'
VSDTC
SUPPVS.QVAL when
QNAM='STUDYDAY'
VSSTAT='NOT DONE'
when VSTESTCD='TEMP'
VSSCAT='SYSTEMIC'
Page 31
CE=Clinical Events
CESCAT='SYSTEMIC'
CECAT='REACTOGENICITY'
CEOCCUR='Y'
CETERM
FACAT='REACTOGENICITY'
VSCAT='REACTOGENICITY'
FAORRES='N' when
FATESTCD='OCCUR'
FAORRES='Y' when
FATESTCD='OCCUR'
FAORRES when
FATESTCD='SEV'
[NOT SUBMITTED]
VSTEST='Temperature'
FATEST='Occurrence Indicator'
FATEST='Severity/Intensity'
CETERM='Fever'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058232
8
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
9
None
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threateningNone
Mild
Moderate
Severe
Potentially life
threatening
More rows 1 5 10BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
Page 32
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058233
Any oca /system c react ons NOT RELATED to
IMPUnrelated Clinical Events (2.0)
No Yes [1]
Category [2] Study Day
[3]Date [4] T me [5] Test Name [6] Loca /system c react on
[7]
More rows
Please insert as many new rows as needed.BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
FACE=Findings About Clinical Events
FADTC
FAOBJ
Page 33
SUPPFACE.QVAL when
QNAM='STUDYDAY'
FACAT='REACTOGENICITY'
FASCAT
[NOT SUBMITTED]
FATEST='Occurrence Indicator'
FAORRES='Y' when FATESTCD='OCCUR'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058234
Any Adverse Events?Adverse Events (2.0)
AE epo ng acco d ng BNT 62 epo ng of AE and eac ons 03Ju y2020
No Yes [1]
AE No.
[2]Adverse Event
[3]Serious [4] Reason,
select all that apply
[5]AE of special
interest [6]Epi /Pandemic
related
[7]Start Date [8] Start ime
[9] Start
ime
unkn.
[10]End Date [11] End ime
[12] End
ime
unkn.
[13]Ongoing [14] Severity/ ntensity
[15]ntensity
(toxicity
grading
scale [16]reatment
emergent AE
[17]Relationship
to MP
reatment
[18]DL (Dose
limiting
toxicity
[19]Action
taken
with MP
reatment
[20]Concomitant
medication or
therapy
[21]Outcome of AE [22] AE
Group
D
[23]
1No YesCongenital
Anomaly or Birth
Defect
Persist or
Signif
Disability/ ncapacityResults in
Death
Requires or
Prolongs
Hospitalizations Life
h
reatening
Other
Medically mportant
Serious EventNo Yes No Yes No YesMild
Moderate
SevereMild
Moderate
Severe
Potentially
Life
hreateningNo YesNot
related
RelatedNo Yes Dose not
changed
Dose
reduced
Drug
interrupted
Drug
withdrawnNot
applicable
UnknownNo YesNot
recovered/not
resolved
Recovered/resolved
Recovered/resolved
with sequelae
Recovering/resolving
Fatal
Unknown
2
No YesCongenital
Anomaly or Birth
Defect
Persist or
Signif
Disability/ ncapacityResults in
Death
Requires or
Prolongs
Hospitalizations Life
h
reatening
Other
Medically mportant
Serious EventNo Yes No Yes No YesMild
Moderate
SevereMild
Moderate
Severe
Potentially
Life
hreateningNo YesNot
related
RelatedNo Yes Dose not
changed
Dose
reduced
Drug
interrupted
Drug
withdrawnNot
applicable
UnknownNo YesNot
recovered/not
resolved
Recovered/resolved
Recovered/resolved
with sequelae
Recovering/resolving
Fatal
Unknown
3
No YesCongenital
Anomaly or Birth
Defect
Persist or
Signif
Disability/ ncapacityResults in
Death
Requires or
Prolongs
Hospitalizations Life
h
reatening
Other
Medically mportant
Serious EventNo Yes No Yes No YesMild
Moderate
SevereMild
Moderate
Severe
Potentially
Life
hreateningNo YesNot
related
RelatedNo Yes Dose not
changed
Dose
reduced
Drug
interrupted
Drug
withdrawnNot
applicable
UnknownNo YesNot
recovered/not
resolved
Recovered/resolved
Recovered/resolved
with sequelae
Recovering/resolving
Fatal
Unknown
4
No YesCongenital
Anomaly or Birth
Defect
Persist or
Signif
Disability/ ncapacityResults in
Death
Requires or
Prolongs
Hospitalizations Life
h
reatening
Other
Medically mportant
Serious EventNo Yes No Yes No YesMild
Moderate
SevereMild
Moderate
Severe
Potentially
Life
hreateningNo YesNot
related
RelatedNo Yes Dose not
changed
Dose
reduced
Drug
interrupted
Drug
withdrawnNot
applicable
UnknownNo YesNot
recovered/not
resolved
Recovered/resolved
Recovered/resolved
with sequelae
Recovering/resolving
Fatal
Unknown
5BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
AE=Adverse Events
AESPID
AETERM
AESER
AESCONG
[NOT SUBMITTED]
AESDISAB
AESDTH
AESHOSP
AESLIFE
AESMIE
AECAT = 'GENERAL' when 'No'
AECAT = 'SPECIAL INTEREST' when 'Yes'
SUPPAE.QVAL when
QNAM='AEEPRELI'
[NOT SUBMITTED]
[NOT
SUBMITTED]
AEENRTPT='ONGOING'
AEENTPT='END OF STUDY'
AESEV
SUPPAE.QVAL when
QNAM='AETRTEM'
AEREL
SUPPAE.QVAL when
QNAM='AE_DLT'
AEACN
AECONTRT
AEOUT
AEGRPID
Page 34
AETOXGR
AESTDTC
AEENDTC
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058235
5
No YesCongenital
Anomaly or Birth
Defect
Persist or
Signif
Disability/ ncapacityResults in
Death
Requires or
Prolongs
Hospitalizations Life
h
reatening
Other
Medically mportant
Serious EventNo Yes No Yes No YesMild
Moderate
SevereMild
Moderate
Severe
Potentially
Life
hreateningNo YesNot
related
RelatedNo Yes Dose not
changed
Dose
reduced
Drug
interrupted
Drug
withdrawnNot
applicable
UnknownNo YesNot
recovered/not
resolved
Recovered/resolved
Recovered/resolved
with sequelae
Recovering/resolving
Fatal
Unknown
More rows 1 5 10BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
Page 35
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058236
Any pr or/concom tant med cat on/therapy?Prior/Concomitant Medication/Therapy (2.0)
No Yes
Medication/ herapy aken prior to
Study?Start Date Start imeStart
ime
unkn.End Date End imeEnd ime
unkn.Ongoing Route Other route,
specifyndividual dose Unit Other unit,
specifyFrequency Other frequency,
pecifyndication AE Nos.
1 No Yes No Yes
2
No Yes No Yes
3
No Yes No Yes
4
No Yes No Yes
5
No Yes No Yes
More rows 1 5 BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
CM=Concomitant/Prior Medications
CMTRT
CMSTRTPT=
'AFTER'
CMSTRTPT=
'BEFORE'
CMSTTPT='STUDY START'
CMSTDTC
[NOT SUBMITTED]
[NOT SUBMITTED]
CMENDTC
CMENRTPT=
'ONGOING'
CMENTPT=
'END OF STUDY'
CMROUTE
SUPPCM.QVAL when
QNAM='O_ROUTE'
CMDOSTXT
CMDOSU
SUPPCM.QVAL when
QNAM='O_UNIT'
CMDOSFRQ
SUPPCM.QVAL when
QNAM='O_FREQ'
CMINDC
SUPPCM.QVAL
when
QNAM='AE_NO1'
SUPPCM.QVAL
when
QNAM='AE_NO3'
SUPPCM.QVAL
when
QNAM='AE_NO2'
[NOT SUBMITTED]
Page 36
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058237
Any Comments?Comments (2.0)
No Yes
V s t Modu T mepo nt Comment Date of Comment
2
3
4
5
More rows: 5 0BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
CO=Comments
COREF
COVAL
COVAL1
CODTC
[NOT SUBMITTED]
Page 37
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058238
Any Protoco Dev at ons?Protocol Deviations (2.1)
No Yes
V s t Modu T mepo nt
Descr pt on of Dev at onReason for Dev at on
CategoryDate of Occurrence
2
3
4
5
More rows: 5 0BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
22/04/2020
Blank eCRF (CTP 3.0)
DV=Protocol Deviations
DVREFID
DVDECOD
DVTERM
DVSTDTC
[NOT SUBMITTED]
if DVDECOD=
'COVID 19 IMPACT',
SUPPDV.QVAL='Y' when
QVAL='DVEPRELI'.
Otherwise,
SUPPDV.QVAL='N' when
QVAL='DVEPRELI'
SUPPDV.QVAL when
QNAM='DVREAS'
Page 38
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058239
Category
Spec men
Informed Consent for pharmacogenet c
ana ys s g ven?
Date of IC for pharmacogenet c ana ys s
T me of IC for pharmacogenet c ana ys s
Informed Consent for separate HLA typ ng
samp ng g ven?
Date
T me
Date of HLA typ ng samp ng
T me of HLA typ ng samp ngInformed Consent + Blood Sampling for HLA typing
[1]
[2]
No Yes [3]
[4]
[5]
Aliquot taken from previous CMI sampling
Date of prev ous CMI samp ng for ana ys s [6] T me of prev ous CMI samp ng for ana ys s [7]
More rows: 5 0
Please insert as many new rows as needed.
No Yes [8]
[9]
[10]
Separate Blood Sampling for HLA typing taken
[11]
[12]
HLA typing Blood Sampling aliquot taken from CMI sampling
Date of correspond ng CMI samp ng [13] T me of correspond ng CMI samp ng [14]
More rows: 5 0
Please insert as many new rows as needed.BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
XACAT='PHARMACOGENETIC ANALYSIS'
[NOT SUBMITTED]
XAORRES when XATESTCD='IC_GIVEN'
XADTC
SUPPXA.QVAL when QNAM='PG_CMI',
QLABEL='PG Aliquot from previous CMI'
XACAT='HLA TYPING SAMPLING'
XAORRES when XATESTCD='IC_GIVEN'
XADTC
SUPPXA.QVAL when QNAM='HLA_BS',
QLABEL='Separate Blood Sampling for HLA'
SUPPXA.QVAL when QNAM='HLA_CMI',
QLABEL='HLA Aliquot from previous CMI'
XA=Ancillary Analysis and Visit Details
Page 39
XATEST='Informed Consent given'
XATEST='Informed Consent given'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058240
Informed Consent (uns.) (2.1)
Category [1] Date [2] T me [3] Protoco Vers on
[4]
More rows: 5 0
Please insert as many new rows as needed.BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
DS=Disposition
DSCAT='PROTOCOL MILESTONE'
DSSTDTC
SUPPDS.QVAL when
QNAM = 'PROTVERS'
Page 40
DSTERM/DSDECOD='INFORMED CONSENT RECONSENTED'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058241
Category
Spec men
Informed Consent for B ood samp ng for
research purposes?
Date
T meInformed Consent + Blood Sampling for Research
[1]
[2]
No Yes [3]
[4]
[5]
B ood Samp ng for Research purposes
Date of B ood samp ng [6] T me of B ood samp ng [7]
More rows: 5 0
Please insert as many new rows as needed.BioNTech BNT162 01 CRS 049 20 DEV
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
15/07/2020
Annotated eCRF (CTP 7.0)
XACAT='BLOOD SAMPLING FOR RESEARCH'
[NOT SUBMITTED]
XAORRES when XATESTCD='IC_GIVEN'
XADTC
SUPPXA.QVAL when QNAM='RES_BS',
QLABEL='Blood Sampling for Research Purposes'
XA=Ancillary Analysis and Visit Details
Page 41
XATEST='Informed Consent given'
090177e196736676\Final\Final On: 08-Mar-2021 02:01 (GMT)
FDA-CBER-2021-5683-0058242