University of Rochester
Protocol #: ____________ Site #: _________
Randomization/Baseline Visit <insert date>
The subject (name) met all inclusion and exclusion criteria for the XXX study. Please see consenting note for full study title.
All randomization study visit details were completed before administering study medication/investigational product.
Subject completed protocol-specified Quality of Life surveys before any study related matters were discussed or initiated.
Adverse Events: None reported.
Subject took her first doses of study IP at 1330, witnessed by writer. Subject may be on <insert Study IP
Name> at 100mg twice daily, or placebo.
She/he was provided an Emergency Contact card and I instructed her/him to contact the clinic office at any point if she/he had questions, concerns or unexplained health changes. Subject voiced understanding.
Her/His next visit is Week 4. I plan to contact her/him by phone within a week to check health status and continued understanding of research study.
<signature & date>
01MAY13