Randomization and Enrollment Form
Randomization and Enrollment Form Version 2.0
Is the participant eligible for the study based on Inclusion and Exclusion criteria? Yes No
(If no leave the rest of the form blank)
If yes:
1. Date enrolled (met all eligibility criteria): ______/________/____________ (dd/mmm/yyyy)
2. Date randomized if different from enrolled: ______/________/____________ (dd/mmm/yyyy)
3. Assigned Group or Kit Number: ________
4. Starting Dose: _______ [specify units]*
5. Frequency: _______*
6. If eligible and not randomized, indicate reason: *
Failed to return Declined participation Other (specify): ______________________
* Optional
Date Informed Consent Signed: _______/________/____________
dd mmm yyyy
STUDY NAME:
Site Number:_____________ Visit Date: ______/_______/___________
dd mmm yyyy
Pt_ID:_____________
Visit Type (check one): Screening Baseline