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Corrective and Preventive Action (CAPA) Plans

While conducting research, even the most experienced and diligent research teams may deviate from the approved protocol or experience unexpected events. Corrective and preventive actions (CAPA) are actions that research teams can take to identify, evaluate, and respond to these deviations and unexpected events to protect the rights, welfare, and safety of participants and others, and the integrity of the research data. The CAPA plan and the event(s) that triggered the need for a CAPA plan must be documented within the study regulatory records. CAPA plans should detail Principal Investigator (PI) oversight. If the event requires reporting to the sponsor and IRB, the reports should be accurate, thorough, and inclusive of the CAPA plan. The IRB evaluates proposed CAPA plans to ensure they are SMART (i.e., specific, measurable, achievable, realistic, and time-bound) and may provide recommendations or request more information.

Step 1: Take Immediate Corrective Actions

If you become aware of a deviation or unexpected event that endangers the rights, welfare, or safety of participants and others, you may take immediate corrective actions without first obtaining IRB approval.

Immediate corrective actions may be in the form of a phone call or an office visit with the participants and a qualified research team member to assess the participants’ rights, welfare, and safety. The investigator may need to order tests and other procedures to ensure the participant is well and safe.

Step 2: Conduct a Root Cause Analysis (RCA)

Once the rights, welfare, or safety of participants and others are assured, it is important to identify the cause or source of a deviation or problem to prevent a recurrence.  There may be multiple reasons or causes that contribute to a problem, and there may be multiple methods to resolve each cause.  The root cause is the initiating, most basic cause of a problem that may or may not lead to a chain of causes or other problems.  Eliminating the root cause should prevent a recurrence of the deviation or problem.

The performance of a root cause analysis (RCA) is the process of identifying and documenting the root cause and the downstream effect on the causal chain. An RCA should focus on identifying underlying problems that contribute to error rather than focusing on mistakes made by individuals.

Steps:

  1. Identify and describe the problem clearly
  2. Interview those impacted by the problem
  3. Interview those people responsible for the problem, if applicable
  4. Establish a timeline from normalcy until the time the problem occurred
  5. Evaluate the probability of the problem happening again and analyze how to prevent recurrence  

Questions to identify root causes:

  1. What happened? What is the problem?
  2. Why and how did the problem occur? When did the problem occur? What were the steps?
  3. Who was affected by the problem? Was it one participant or all participants in the study?
  4. What is the magnitude of the problem? Is it in one study, or does the problem exist in all studies under this PI or even in an entire clinical department?

There are several different methods and techniques to conduct an RCA. One such technique is called the 5 Whys, in which you would keep asking the questions "why did that happen?" until you get past the symptoms of a problem and down to the root cause.

Once you have identified the root cause of each problem, your next step is to develop a corrective and preventive action (CAPA) plan to eliminate the root cause and prevent recurrence.

Step 3: Prepare the CAPA Plan

Corrective actions are those that will resolve a problem, and preventive actions are those that will keep the problem from happening again.

Corrective Actions

After you have assessed the participants' rights, welfare, and safety, taken immediate corrective actions, and identified the root cause, you should consider preparing to take additional actions that may require IRB review and approval before implementation. This may look like revising the study protocol or consent form and submitting it for IRB review and approval after noticing that study staff or participants have repeatedly misunderstood an important feature of the study.

Preventive Actions

Preventive actions are necessary to ensure that the problem does not happen again. This may look like creating and documenting a process or standard operating procedure (SOP). For example, implementing using study visit checklists to ensure compliance and minimize confusion with various study procedures on different study visits, training study staff on the process, implementing the process, evaluating the process, and amending the process as necessary.  It may be necessary to consider whether you need to revise other study documents as a part of your preventive action plan.

Step 4: Document the CAPA Plan

CAPA plans must be thorough and well documented. In your plan, include information that is SMART: 

  • Specific: Identify the actions you or others will take to address the root cause, the individual (role) responsible for taking the actions, and where you will document the actions.
  • Measurable: Include a process of assessing the action plan effectiveness and a process by which the plan will be amended if it is ineffective. Questions you may consider asking yourself include: How will I know if I have achieved this goal? How will I measure the progress and know I am moving in the right direction? How will I know when my goal has been accomplished?
  • Achievable: Setting goals that you can meet is incredibly important in avoiding setting yourself up for failure.
  • Realistic: Consider whether you have the resources available to accomplish the goals.
  • Time-bound: Include the estimated date(s) when you or others will complete the actions.

 A thorough CAPA plan must include the following elements:

  1. Action type (corrective and preventive)
  2. Action description
  3. Responsible person
  4. Due date
  5. Plan for effectiveness check
  6. Effectiveness check outcomes

You must create and maintain documentation that demonstrates that you implemented the CAPA plan. This might be meeting agenda(s), training sign-in sheet, emails, new checklist, tool, etc. The IRB or sponsor may request to review this documentation.

The following resources may guide your team in creating and documenting your CAPA plan, and they can be maintained in the study regulatory record to support compliance and ongoing oversight:

  • CAPA Plan Self-Assessment (HRP-1210)
    Supports investigators to document and report on the implementation and adherence to the CAPA plan. The IRB Office recommends completing a CAPA plan self-assessment approximately 3-6 months after CAPA plan implementation to evaluate adherence and effectiveness.

CAPA Plan Example

  • Event: During an internal audit of the study, the PI discovered that a recent hire had performed research activities prior to the study team receiving IRB approval to add the new hire to the list of study team members in eIRB+.
  • Root Cause: There was no process to ensure that new hires to the research team had taken all required actions before participating in Human Subject Research. The research manager prepared a modification (MOD) to the IRB to add a new hire to the list of study team members on eIRB+. Since the new hire has not completed their human research protections training, eIRB+ did not allow the research manager to submit the MOD. After the new hire completed their required training, the research manager directed the new hire to recruit, screen, and enroll participants into the study, forgetting that the MOD still needed to be submitted and approved by the IRB. 
  • Corrective Actions: The PI and research manager reviewed the study history and IRB-approved study team member list with the study team history and determined that there was only one occurrence where an unapproved member of the study team participated in the research.  The research manager documented these actions in a note-to-file (NTF), used the Incident Assessment Tool to determine IRB reportability, and stored the NTF in the study regulatory record.
  • Preventive Actions: The research manager created an SOP for new hire onboarding and a supporting checklist.  The research manager and PI will ensure they appropriately onboard new hires before they participate in research by utilizing the new hire checklist.  The final step of the onboarding process is the sign-off on the checklist by both the research manager and the PI.  The research manager created an NTF indicating the start date of the new SOP and checklist.  The completed checklists will be kept in the study regulatory record with the delegation of authority log.  The research manager and the PI will review the implementation of the new SOP and checklist after each of the next three new hires.  They will document their review in an NTF to be kept in the study regulatory record.  If the result of the reviews is that the SOP and checklist are working as expected, an NTF will be placed in the study regulatory record indicating the plan as effective, and the next effectiveness check will occur on an annual basis to ensure continued compliance and effectiveness.  If the SOP and/or checklist require revision, the revisions will be documented in an NTF to be kept in the study regulatory record, and the process for evaluating the next three new hires will start again.