Notes to File
This type of document is created to explain a missing signature, misfiled document, or protocol clarification.
What is a Note to File?
A minor deviation is typically defined as a protocol deviation that does not impact this.
What is participant safety or data integrity?
A major deviation typically affects this, which can compromise study validity.
What is participant safety or data quality?
A note to file should always be this—clear, factual, and avoid assigning blame.
What is objective?
Missing a single study visit by 2 days would usually be categorized as this type of deviation.
What is a minor deviation?
Enrolling a participant who does not meet inclusion criteria is considered this level of deviation.
What is a major deviation?
This type of person at the research site is typically responsible for writing a Note to File.
Who is the Principal Investigator (PI)?
Minor deviations may still need to be reported to this oversight body at the site.
What is the Institutional Review Board (IRB) or Ethics Committee (EC)?
Major deviations must often be reported to both the sponsor and this oversight body.
What is the IRB or EC?
Notes to File should be signed and dated, and should include this to justify its creation.
What is the rationale or explanation?
This document must often be updated or annotated to reflect recurring minor deviations.
What is the protocol deviation log?
Failure to obtain this critical document before a procedure can constitute a major deviation.
What is informed consent?
Regulators may view excessive use of Notes to File as a red flag indicating poor this.
What is documentation or study conduct?
Repeating the same minor deviation can cause it to be reclassified as this.
What is a major deviation?
This regulatory agency may impose penalties or halt a study if major deviations are systemic and unresolved.
What is the FDA?