Data Review
busaxirilwam
Studyoutlinefordatareviewexercise_May2022.docx
Study Procedures
|
Visit Number |
1 |
2 |
3 |
4 |
|
Visit Window (Days) |
Day 1 |
28 to 42 Days After Visit 1 (Study Day 29 to 43) |
28 to 42 Days After Visit 2 |
168 to 196 Days After Visit 2 |
|
Informed consent |
X |
|
|
|
|
Demography |
X |
|
|
|
|
Review inclusion criteria |
X |
|
|
|
|
Review exclusion criteria |
X |
|
|
|
|
Medical history |
X |
|
|
|
|
Physical exam |
X |
|
|
|
|
Urine pregnancy |
X |
X |
|
|
|
Investigational product administration |
X |
X |
|
|
|
AE and SAE collection |
X |
X |
X |
X |
|
|
Example partial blank case report form:
