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?
The site used an outdated version of a source document template, but the data collected was still valid.
What is note to file
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?
A subject missed a scheduled visit due to a personal emergency, but the visit was completed two days later without impacting safety assessments.
What is minor 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?
A study coordinator forgot to collect a participant's signature on the updated informed consent form, but the participant continued in the study.
What is Major Deviation
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?
The temperature log for the investigational product refrigerator was not recorded for one day, but the temperature remained within range.
What is Minor Deviation
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?
A subject was enrolled despite not meeting one of the inclusion criteria.
What is Major Deviation