Corrective and Preventative Action Plans (CAPAs) - PowerPoint Presentation

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Corrective and Preventative Action Plans (CAPAs)

Common Pitfalls and Solutions

Human Research Protection Program (HRPP)

HRPP COMPLIANCE AND QUALITY TEAM

Yale University

Preventing Deviations/Noncompliance in the First Place is Key

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CAPAs:

6 Common Pitfalls and Solutions

1. Missing the Basic Elements

Pitfalls

:

All of the issues have not been addressed

Deficiencies are addressed in part, not whole

No timeframe of completion has been provided

There is no initiation or implementation of change

Responses are vague, lack detail or clarity

1. Missing the Basic Elements

(continued)

Solution

:

The Best CAPAs:

Respond point-by-point to the issues

Correspond to the deviation that they are addressing

Provide a time frame of completion

Provide specific details

2. Overpromising

Pitfall

:

Actions are promised that cannot reasonably be fulfilled or satisfied in the provided timeframe

Solution

: Actions should be able to be completed and carried out in the proposed timeframe, and necessary resources should be available.

Departmental support should be provided for serious cases with significant CAPAs

3. Addressing Only the Current Issue at Hand

Pitfall

:

The response does not address the larger issue

(e.g., eight subjects did not sign the correct version of a consent form and will be approached to provide consent using the correct form; the CAPA does not address the reasons(s) behind why the deficiency transpired)

No steps are proposed or actions offered that will stop the issue from reoccurring in the future.

3. Addressing Only the Current Issue

at Hand

(continued)

Solution

:

A good CAPA takes a two-pronged approach.The proposed CAPA should adequately address:

The current issue at hand

(i.e., include a specific remedy for the eight affected subjects), and

The larger issue as a whole

(i.e., what steps have been put in place to ensure that, going forward, all subjects will sign the correct consent form)

4.

The CAPA Does Not Address the Issue

Pitfall

:

The provided CAPA does not connect with the deficiency

Solution: A good CAPA should adequately address the underlying issues/deficiencies and demonstrate an element of learning/education.

The CAPA should address the individual incident and any larger problematic/systemic issues

The CAPA should prevent a reoccurrence of the identified deficiencies/issues going forward.

5. A Lack of Ownership or Responsibility for the Deficiency

Pitfall

:

The CAPA does not involve all responsible parties or exhibits a lack of ownership by the PI or parties involved in the deficiencies.

Solution

: A CAPA should reflect the accountability of all involved parties; it is noted, however, that the PI is ultimately responsible.

6. Stating the Obvious

Pitfall

:

The CAPA is a vague

‘promise'

with no plan: “Don’t worry, it won’t happen again” or “We’ll be more careful next time” “We will continue to ensure…”

Solution

:

A CAPA that contains statements of action and demonstrates learning will help ensure the CAPAs success as opposed to statements of acknowledgement alone.

Case Scenarios

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CASE SCENARIO #1

A new study coordinator is hired to work on a research project. In reviewing the study records, she identifies that 12 of the 17 subjects enrolled had problems with the consent forms that were signed.

5 signed expired consent forms [content identical to the currently approved consent form];

7 signed consent forms that were not stamped approved by the IRB and did not contain information about recently added remuneration (as approved by the IRB);

All 12 subjects with consent issues remain on study in follow up.

Question

: What could be an effective CAPA?

Have the 12 subjects re-sign an IRB-approved, stamped consent at their next visit, study team re-training, note to file (NTF) to document the issue.

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CASE SCENARIO #2

HIC #4567 enrolls subjects with advanced Parkinson’s Disease. During a recent monitoring visit, the monitor noted that 12 of the 30 study subjects provided only verbal consent to participate. The Principal Investigator recalls that the 12 subjects were unable to physically provide written consent due to their medical condition. The reasons for the lack of written consent were not documented in any of the 12 subjects’ research records.

Question

: What could be an effective CAPA?

Create a note to file (NTF) for each of the 12 subjects to document the consent process that transpired, submit a modification to the protocol immediately to the IRB that includes a plan to ensure subjects who are physically unable to provide written consent go through the consent process appropriately. Report these deviations to the IRB in accordance with Yale policies. Retrain the PI and study team regarding consent and implementing a study modification without approval.

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CASE SCENARIO #3

During a self-review for QI, the study team noticed that for four subjects, the study team member obtaining consent used the previous version of the study consent form, and, in writing, edited the form to include the revised information (i.e., increase in target number, addition of urine collection at three time points).

The CAPA provided included the following: the subjects have since been provided with and signed a new, clean, currently approved consent form. The study team member obtaining consent has been reeducated regarding this issue.

Question

: What is MISSING from the CAPA that was provided?

A Note to File (NTF) should also be written by the study team and added to the study file to explain the 3 consent deviations and efforts taken to remedy/address such deviations.

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