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Basic Information

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General Study Assumptions
Molecule:

Indication:

Protocol # (if known):

Phase:

Global or US: Global US

Number of countries if global:

Number of sites:

Number of patients:

Per patient costs needed? Yes No

Please provide a list of assessments or study with similar assessments:

Timeline
Timeline Date

FPI:

LPI:

LPO:

Database Lock:

Please fill out the appropriate fields for each service requested:

Central Lab ( What’s This? )
# of lab visits:

# of safety tests:

Specialty Lab ( What’s This? )
Validated assay: Yes
No

# of specialty test:

IVRS ( What’s This? )
# of language translations:

IRF ( What’s This? )
# of timepoints (visits):

# of scans/visit
(chest, abdomen, pelvis):

# of readers: 1
2

Oncology review: Yes
No

% of digital images (default):

ECG ( What’s This? )
Are ECGs required? Yes
No

Additional Comments
Any additional comments:

Are you human?

Zapatec, Inc.