Document text
Visit:
Visit 0
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
1/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 1
FDA-CBER-2021-5683-0049178
FDA-CBER-2021-5683-0049179
FDA-CBER-2021-5683-0049180
Body Height/Weight + BMI (2.0)
No do eReaso o do e Da e e He g
(c )We g
(kg) Body Mass I dex
(kg/ ²)BMI (ca cu a ed)
(kg/ ²)
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
4/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 4
FDA-CBER-2021-5683-0049181
FDA-CBER-2021-5683-0049182
FDA-CBER-2021-5683-0049183
FDA-CBER-2021-5683-0049184
FDA-CBER-2021-5683-0049185
FDA-CBER-2021-5683-0049186
FDA-CBER-2021-5683-0049187
FDA-CBER-2021-5683-0049188
FDA-CBER-2021-5683-0049189
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
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Page 13
FDA-CBER-2021-5683-0049190
FDA-CBER-2021-5683-0049191
FDA-CBER-2021-5683-0049192
Visit:
Visit 1
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
16/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 16
FDA-CBER-2021-5683-0049193
FDA-CBER-2021-5683-0049194
FDA-CBER-2021-5683-0049195
FDA-CBER-2021-5683-0049196
FDA-CBER-2021-5683-0049197
FDA-CBER-2021-5683-0049198
FDA-CBER-2021-5683-0049199
FDA-CBER-2021-5683-0049200
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
24/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 24
FDA-CBER-2021-5683-0049201
FDA-CBER-2021-5683-0049202
FDA-CBER-2021-5683-0049203
FDA-CBER-2021-5683-0049204
FDA-CBER-2021-5683-0049205
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
29/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 29
FDA-CBER-2021-5683-0049206
Blood Samples for CMI (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
30/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 30
FDA-CBER-2021-5683-0049207
FDA-CBER-2021-5683-0049208
FDA-CBER-2021-5683-0049209
FDA-CBER-2021-5683-0049210
FDA-CBER-2021-5683-0049211
Visit:
Visit 2
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
35/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 35
FDA-CBER-2021-5683-0049212
FDA-CBER-2021-5683-0049213
FDA-CBER-2021-5683-0049214
FDA-CBER-2021-5683-0049215
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
39/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 39
FDA-CBER-2021-5683-0049216
FDA-CBER-2021-5683-0049217
FDA-CBER-2021-5683-0049218
FDA-CBER-2021-5683-0049219
Visit:
Phone Call
at 48h
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
43/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 43
FDA-CBER-2021-5683-0049220
Phone Call (2.0)
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
NA No do e Reaso o do e Da e e Ou co e of e ca (e g No f d gs o ew AEs/CMs epo ed)
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
44/139
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Page 44
FDA-CBER-2021-5683-0049221
Visit:
Visit 3
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
45/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 45
FDA-CBER-2021-5683-0049222
FDA-CBER-2021-5683-0049223
FDA-CBER-2021-5683-0049224
FDA-CBER-2021-5683-0049225
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
49/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 49
FDA-CBER-2021-5683-0049226
FDA-CBER-2021-5683-0049227
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
51/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 51
FDA-CBER-2021-5683-0049228
FDA-CBER-2021-5683-0049229
FDA-CBER-2021-5683-0049230
Visit:
Visit 4
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
54/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 54
FDA-CBER-2021-5683-0049231
FDA-CBER-2021-5683-0049232
FDA-CBER-2021-5683-0049233
FDA-CBER-2021-5683-0049234
FDA-CBER-2021-5683-0049235
FDA-CBER-2021-5683-0049236
FDA-CBER-2021-5683-0049237
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
61/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 61
FDA-CBER-2021-5683-0049238
FDA-CBER-2021-5683-0049239
FDA-CBER-2021-5683-0049240
Visit:
Phone Call
at 48h (a1, b1, b2, c2P/B)
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
64/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 64
FDA-CBER-2021-5683-0049241
Phone Call (2.0)
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
NA No do e Reaso o do e Da e e Ou co e of e ca (e g No f d gs o ew AEs/CMs epo ed)
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
65/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 65
FDA-CBER-2021-5683-0049242
Visit:
Visit 5
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
66/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 66
FDA-CBER-2021-5683-0049243
FDA-CBER-2021-5683-0049244
FDA-CBER-2021-5683-0049245
FDA-CBER-2021-5683-0049246
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
70/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 70
FDA-CBER-2021-5683-0049247
FDA-CBER-2021-5683-0049248
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
72/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 72
FDA-CBER-2021-5683-0049249
Blood Samples for CMI (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
73/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 73
FDA-CBER-2021-5683-0049250
FDA-CBER-2021-5683-0049251
FDA-CBER-2021-5683-0049252
Visit:
Visit 6
(a1, b1, b2, c2P/B) / (c2) (EoT)
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
76/139
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Page 76
FDA-CBER-2021-5683-0049253
FDA-CBER-2021-5683-0049254
FDA-CBER-2021-5683-0049255
FDA-CBER-2021-5683-0049256
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
80/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 80
FDA-CBER-2021-5683-0049257
FDA-CBER-2021-5683-0049258
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
82/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 82
FDA-CBER-2021-5683-0049259
Blood Samples for CMI (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
83/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 83
FDA-CBER-2021-5683-0049260
FDA-CBER-2021-5683-0049261
FDA-CBER-2021-5683-0049262
Visit:
Visit 7
(a1, b1, b2, c2P/B) (EoT)
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
86/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 86
FDA-CBER-2021-5683-0049263
FDA-CBER-2021-5683-0049264
FDA-CBER-2021-5683-0049265
FDA-CBER-2021-5683-0049266
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
90/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 90
FDA-CBER-2021-5683-0049267
FDA-CBER-2021-5683-0049268
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
92/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 92
FDA-CBER-2021-5683-0049269
FDA-CBER-2021-5683-0049270
FDA-CBER-2021-5683-0049271
Visit:
Visit 7
(c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU)
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
95/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 95
FDA-CBER-2021-5683-0049272
FDA-CBER-2021-5683-0049273
FDA-CBER-2021-5683-0049274
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
98/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 98
FDA-CBER-2021-5683-0049275
Visit:
Visit 8
(c2) (FU) / V 9 (a1, b1, b2, c2P/B) (FU)
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
99/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 99
FDA-CBER-2021-5683-0049276
FDA-CBER-2021-5683-0049277
FDA-CBER-2021-5683-0049278
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e No do e Reaso o do e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
102/139
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Page 102
FDA-CBER-2021-5683-0049279
Visit:
End of
Trial
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
103/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 103
FDA-CBER-2021-5683-0049280
FDA-CBER-2021-5683-0049281
FDA-CBER-2021-5683-0049282
Visit:
Unrelated Forms
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
106/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 106
FDA-CBER-2021-5683-0049283
FDA-CBER-2021-5683-0049284
FDA-CBER-2021-5683-0049285
FDA-CBER-2021-5683-0049286
FDA-CBER-2021-5683-0049287
FDA-CBER-2021-5683-0049288
FDA-CBER-2021-5683-0049289
FDA-CBER-2021-5683-0049290
FDA-CBER-2021-5683-0049291
FDA-CBER-2021-5683-0049292
FDA-CBER-2021-5683-0049293
FDA-CBER-2021-5683-0049294
FDA-CBER-2021-5683-0049295
FDA-CBER-2021-5683-0049296
Visit:
Unscheduled Forms
CRS Study Code: 049/20
Sponsor Study Code: BNT162-01
07/08/2020
Blank eCRF (CTP 8.0)
120/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 120
FDA-CBER-2021-5683-0049297
FDA-CBER-2021-5683-0049298
FDA-CBER-2021-5683-0049299
FDA-CBER-2021-5683-0049300
FDA-CBER-2021-5683-0049301
Body Height/Weight + BMI (2.0)
Da e e We g
(kg)
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
125/139
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Page 125
FDA-CBER-2021-5683-0049302
FDA-CBER-2021-5683-0049303
FDA-CBER-2021-5683-0049304
FDA-CBER-2021-5683-0049305
FDA-CBER-2021-5683-0049306
Urine Sampling for Urinalysis (2.0)
Ca ego y Spec e Da e e
1
Mo e ows: 1 5 10
All 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
07/08/2020
Blank eCRF (CTP 8.0)
130/139
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Page 130
FDA-CBER-2021-5683-0049307
FDA-CBER-2021-5683-0049308
FDA-CBER-2021-5683-0049309
Blood Samples for Immunogenicity (2.1)
Ca ego y Spec e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
133/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
Page 133
FDA-CBER-2021-5683-0049310
Blood Samples for CMI (2.1)
Ca ego y Spec e Da e e
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
134/139
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Page 134
FDA-CBER-2021-5683-0049311
FDA-CBER-2021-5683-0049312
Phone Call (2.0)
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
Da e e Ou co e of e ca (e g No f d gs o ew AEs/CMs epo ed)
1
Mo e ows: 1 5 10
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
07/08/2020
Blank eCRF (CTP 8.0)
136/139
090177e194f39051\Approved\Approved On: 18-Sep-2020 07:16 (GMT)
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