Writing an Effective Corrective Action Plan

Step 1: Clearly state the problem or weakness, including the root cause.

  • Define the Problem:
    • What is happening?
      • What is the effect?
    • What should be happening?
    • How can it be fixed?

Step 2: List the individuals who will be accountable for the results of the corrective action

  • Who should be responsible?
    • If applicable, how will they be trained to carry out their expected duties?
  • How will they report issues/problems?
    • To whom are issues reported?
    • When should they report problems?

Step 3: Create simple, measurable solutions that address the root cause

  • What are the regulatory requirements?
  • What are the IRB requirements?
  • What are the available resources allocated for the study?
  • What can be reasonably accomplished?

Step 4: Each solution should have a person that is accountable for it.

  • Should one person be solely accountable?
  • Should two people share the responsibility?
  • Should there be a segregation of duties?

Step 5: Set achievable deadlines

  • How many people are dedicated to the effort of re-writing SOPs, Consents or protocols?
    • Does an external entity (i.e. Sponsor) need to sign off on the changes?
    • What is a reasonable time frame to develop and train 10 people? 20? 100?

Step 6: Monitor the progress of your plan.

  • When will supporting documentation be needed?
    • At the next periodic review?
    • On hand, in case of an audit?
    • If another problem occurs?
  • What type of supporting documentation will be needed
    • for the IRB?
    • FDA?
    • OHRP?
    • NIH?
    • the Sponsor?

Required Corrective Actions vs. Recommended Corrective Actions

Required Recommended

All actions must be addressed promptly to meet federal regulations, guidelines and IRB/NMH policies.

If the required action is not feasible, then justification should be provided.

Consider all recommended actions as they are strongly encouraged.

Decide the following that is best for you:

  • Accept Action
  • Postpone Action
  • Decline Action
  • Acknowledge