A Root Cause Analysis (RCA) is a structured process used to identify the underlying reason an issue occurred—not just what happened, but why it happened.

When is it required?

RCA is recommended (and may be requested) when:

• There is a serious protocol deviation or pattern of noncompliance
• An unanticipated problem presents risk to participants
• Corrective actions are needed to prevent recurrence

Key Questions to Guide Your RCA

• What happened?
• When and where did it occur?
• Who was involved?
• Why did it happen (what systems or processes failed)?
• Could it have been prevented?

Tip: Use the “5 Whys” technique—ask "why" repeatedly (up to 5 times) to drill down to the true cause.

A CAPA Plan outlines the specific steps you will take to:

1. Correct the issue that occurred
2. Prevent it from happening again in the future

Elements of a Strong CAPA Plan

• Description of the root cause
  • What led to the issue? Summarize your findings from the RCA.
• Corrective actions taken
  • What immediate steps were taken to resolve the issue (e.g., re-consenting, re-training staff, correcting data)?
• Preventive actions implemented
  • What process changes, policy updates, or tools will be introduced to prevent recurrence?
• Timeline and responsibility
  • Who is responsible for each step, and when will it be completed?
• Follow-up or monitoring
  • How will you confirm the actions were effective?

Issue: A study coordinator enrolled a participant using an outdated consent form.
Root Cause: Study team was unaware of the updated version due to unclear document control processes.
Corrective Action: The participant was re-consented using the correct form.
Preventive Action: PI implemented a centralized consent tracking system and retrained all staff on document version control.

If your RNI requires corrective action:

• Submit the RCA and CAPA Plan as attachments within the RNI submission in Huron.
• Clearly label the documents (e.g., “RCA_Study1234” and “CAPA_Study1234”).
• Reference them in your RNI summary.