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 study participant missed a scheduled visit due to an adverse event, but the visit was completed a week later without impacting safety assessments.
What is a minor deviation?
Who is the Regulatory Administrator and Supervisor?
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 study coordinator forgot to collect a participant's signature on the updated informed consent form, but the participant continued in the study.
What is a major deviation?
Adverse Events get reported here.
What is the Case Report Form (Rave/EDC)?
Notes to File should be signed and dated, and should include this to justify its creation.
What is the rationale or explanation?
Minor deviations may still need to be reported to this oversight body.
What is the Institutional Review Board?
Major deviations must often be reported to both the sponsor and this oversight body.
What is the IRB?
The temperature log for the investigational product refrigerator was not recorded for one day, but the temperature remained within range.
What is Minor Deviation
Study coordinators have 24 hours to report this.
What is a serious adverse event?
The NTF author reports the situation to this type of person.
Who is the Regulatory Administrator and the Supervisor?
Repeating the same minor deviation can cause it to be reclassified as this.
What is a major deviation?
Failure to obtain this critical document before a procedure can constitute a major deviation.
What is informed consent?
A subject was enrolled despite not meeting one of the inclusion criteria.
What is Major Deviation?
Sites where a study is open to accrual are listed here.
What is CTSU site registrations?
Regulators may view excessive use of notes to file as a red flag indicating poor this.
What is documentation or study conduct?
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 regulatory agency may impose penalties or halt a study if major deviations are systemic and unresolved.
What is the Sponsor/FDA?
A site used an outdated consent form.
What is a major deviation?
NCI protocol funding events can be found here.
a. What is the dollar icon on OPEN?
b. What is the CTSU funding sheet?