Oops! I PD'd again!
No Cap on CAPAs
Scribe and Prejudice
Eyedentify This!
Compliant or Compli-ain't?
1
What is a protocol deviation? (be specific)
what is ... Any instance where the study is conducted in a way that does not fully comply with the approved protocol, SOPs, or regulations.
1
What does CAPA stand for?
what is ... Corrective and Preventive Action.
1
Name the guidelines we utilize to ensure proper documentation?
ALCOA+
1
What does an OCT scan measure?
what is...Retinal thickness and structural changes.
1
What is an adverse event (AE) in a clinical trial?
what is...Any untoward medical occurrence in a subject, whether or not related to the investigational drug.
2
Give one example of a minor protocol deviation and one example of a major protocol deviation
Minor: what is ... Subject missed a visit window by one day. Major: what is ... Subject was enrolled despite failing inclusion/exclusion criteria.
2
What is the difference between corrective action and preventive action in a CAPA?
what is...Corrective action fixes the immediate issue; preventive action ensures it does not happen again.
2
Which ALCOA principle does this break: A research coordinator can use white-out on source documentation if they make a mistake.
Original, Enduring, Contemporaneous, Accurate, Consistent
2
What is the primary endpoint in most retinal disease clinical trials?
what is...Change in best-corrected visual acuity (BCVA).
2
Name two reasons why a subject might be withdrawn from a clinical trial.
What is...Safety concerns, protocol noncompliance, investigator decision, sponsor decision, or subject withdrawal of consent.
3
What 3 important evets occurred in the past to create ICH, IRB, and the world of research that we are used to operating in today?
3
What is the first step in developing a strong CAPA?
what is...Conducting a root cause analysis (RCA) to identify the underlying issue
3
Name at least 5 different imaging modalities
OCT, OCT-A, FP, FAF, FA
3
True or False: Retinal vein occlusion is a type of hereditary eye disease.
what is...False. It is a vascular event typically related to hypertension or diabetes.
3
What are the three main ethical principles outlined in the Belmont Report?
What is...Respect for persons, beneficence, and justice.
4
True or False: A minor protocol deviation never needs to be reported to the sponsor
what is ... False. Minor deviations should still be documented and reviewed during monitoring visits
4
What are two common reasons CAPAs fail?
what is...Too vague, no measurable outcomes, failure to assign accountability, not targeting the root cause, or lack of follow-up.
4
A subject verbally denies taking a medication, but it appears in their external medical records. What should the research staff do?
- Document the discrepancy with a continuation note and seek clarification with the subject or prescribing physician.
4
How does OCT-A differ from standard OCT?
4
What is an example of a prohibited therapy in ophthalmology trials, and why would it be restricted?
What are... Systemic steroids, because they could influence inflammation outcomes in a trial studying retinal disease
5
If a site identifies a trend of repeated protocol deviations, what additional step should they take beyond documenting the individual deviations?
what is ... Implement a CAPA to correct the root cause and prevent recurrence.
5
What is an example of a weak CAPA, and how could it be improved?
Weak: "Ensure proper documentation.
"Improved: "Implement a mandatory audit process for all informed consent forms."
5
What does ALCOA+ stand for in clinical research documentation?
what is...Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available.
5
Name 3 different layers of the Retina
ILM, RNFL, RPE, GCL, PR, IPL, ONL
5
Name two consequences of failing to follow ICH GCP guidelines.
What is...Regulatory fines, study suspension, subject safety risk, or invalid data.