IRB approved number of subjects to be enrolled: Informed Reason for Date Eligibility Assigned Additional Consent Signed: Exclusion Screening Screened Criteria Participant Randomization ID Participant Comments (Date or N/A) (Screen Fail, Number Met Initials Assigned ID # Refused to (Copy to Subject (Yes/No) (if enrolled) Participate, etc.) Y/N) PI Signature: _______________________________________________________
IRB approved number of subjects to be enrolled: Screening Number Assigned Participant ID # (if enrolled) Date Screened Eligibility Criteria Met (Yes/No) Participant Initials Informed Consent Signed: (Date or N/A) (Copy to Subject Y/N) Reason for Exclusion (Screen Fail, Refused to Participate, etc.) Randomization ID Assigned Additional Comments PI Signature: _______________________________________________________