The purpose of this is to document continued observations and procedures during the course of the study and the subject's involvement. Best Practice includes: adverse event assessment, Principal Investigator acknowledgement of adverse events, study drug compliance, and other protocol-specific assessments.

University of Rochester
Research Study Visit Summary: = Unscheduled Visit / Change of Treatment
The patient was seen for a study visit today for the <insert name> trial/ protocol. This was an
unscheduled visit due to clinical failure per protocol.
Weight = xxx lb, unchanged from <date>.
Blood Pressure = 113/70
Heart rate = 86
O2 sat 93% (resting)
Adverse Event Assessment/Review:
Denies adverse events since hospital discharge. Is feeling better although continues recovery from
recent surgery (as described in previous note).
Has continued abdominal pressure especially in lower quadrants.
Concomitant Medications Review: Patient reported no new medications or dose changes
Study Procedures: <customize per protocol>
Patient was seen by <PI> and had a standard physical exam.
Central labs were done; reviewed/results located in the study source documents.
Plan/Changes: Will initiate Stage 1 blinded combination therapy within next 1-2 days (pending
study/IVRS assignment). Will monitor patient weekly or more frequently as needed over next one
month. Will have Standard of Care <procedure> in approx 4 weeks.
Study drug compliance 100%; see IP log for specifics.
<Sign, Date>