Page 306 - CHST Research Administration eBook 2 of 2 (Q4 2021)

RESEARCH Visit note in Medical Record includes (as applicable):
Joint Commission
EPIC: Progress note or scanned document
Yes No N/A
Chief Complaint (Research Participant): { Visit Type: RESEARCH
Principle Investigator:
Title of Study/ IRB#:
}
Location of visit:
All inclusion and no exclusion criteria met.
Adverse events and concomitant medications were reviewed.
Assessments and procedures performed at this visit per protocol:
• Vital signs, Height, Weight, etc.
• Medication administered (if indicated)
• Labs (state each lab)
• Physical exam performed by (MD name)
• Subject returned ___ number of study drug (i.e., 3 vials, 15 pills)
• Patient given __ amount of study drug to take home
• Study questionnaires administered prior to study procedures (if indicated)
Patient tolerated procedures and assessments (well, with difficulty, etc)
State any education provided.
Patient, Parents, Mother, Father verbalized understanding of education provided at this visit. Next visit is scheduled for: Month/Year
Documentation of ALL study related procedures and medications
Joint Commission Joint Commission Joint Commission Joint Commission Joint Commission Joint Commission
EPIC: Progress note or scanned document
Yes No N/A Yes No N/A
Documentation of patient's response to all study procedures and medications.
EPIC: Progress note or scanned document
Education is provided in primary language (documentation of interpreter used)
EPIC: Progress note or scanned document
Documentation that patient education was provided related to the study.
EPIC: Progress note or scanned document
Yes No N/A Yes No N/A Yes No N/A
Documentation that patient was informed study follow up plan.
EPIC: Progress note or scanned document
Documentation that parent's verbalized understanding of information.
EPIC: Progress note or scanned document
2011 Research Chart Audit Tool
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