Here are quick tips on corrective action plans

Focus on internal control

Research institutions often need a quick and efficient compliance and quality improvement strategy. One strategy that can satisfy those objectives is the corrective action plan (CAP).

At Ochsner Health Systems in New Orleans, LA, the research and corporate integrity office and the IRB office implemented a CAP process for researchers after realizing the need for an efficient compliance plan, says Stephanie Gaudreau, CIP, IRB administrator at Ochsner Institutional Review Boards, Ochsner Health Systems.

Researchers want to do the right thing, but when they make mistakes, a corrective action plan with education and training requirements can help reinforce compliance and best practices, she notes.

Here are some of Gaudreau's tips on how to create and implement a CAP:

• Require a corrective action plan whenever there is noncompliance: At Ochsner, quality assurance (QA) staff conduct not-for-cause audits that might have noncompliance findings, Gaudreau notes.

The QA office can serve as a liaison between the research team and the IRB office, and if an audit discovers problems, this could trigger a CAP, Gaudreau says.

"We want a plan in place right away to fix the problem," she says. "So we will work with the research team to get the plan submitted."

• Ask investigators to take internal control measures to enhance risk management: "We also recommend researchers create their own internal check sheets or monitoring," Gaudreau says.

For example, there could be a case where a research site did not communicate subject follow-up information from one clinical research coordinator to another, she says.

A CAP addressing this problem might recommend that the site include a check-off sheet that coordinators have to sign to become part of the internal research operations of that unit, she adds.

Internal control is a process that is more than policy manuals and forms; it is affected by people and can be expected to provide reasonable assurance, according to Ochsner's clinical research corrective action plan outline.

Ochsner's CAP outline includes these examples of internal control:

— Policies & procedures/standard operating procedures

— training

— access limit

— segregation of duties: requiring different phases of a transaction to be performed by different people and having at least two people involved in every transaction

— dual controls: a physical restriction that requires two people to access an asset or execute a transaction

— joint custody: having two individuals share the responsibility

— sole accountability: having one person held accountable

— reconciliation

• Liberally add additional education and training to CAPs: The most common feature of a corrective action plan possibly is a requirement for additional education and training.

"The quality assurance group will check their education program, and sometimes we'll ask for follow-up education and training information on the CAPs," Gaudreau says. "There have been a few instances where we've requested a copy of training logs."

Also, research institutions can offer good clinical practice (GCP) training courses and responsible conduct in research training with monthly hot topics that highlight areas that often are problems for research staff.

Other strategies are to provide monthly newsletters that address CAPs to research staff, Gaudreau says.

• Provide a CAP template: Ochsner provides a corrective action plan sample for research sites. It's readily available online at www.ochsner.org. The template has space to note the deficiency found and who is responsible for the overall corrective action plan, as well as asking for a signature from the principal investigator.

It also lists a table for steps, actions, due dates, responsible party, and status/comments.

For instance, one action listed as an example on the Ochsner template is as follows: "A Standard Operating Procedure has been developed and implemented to assist with documentation practices for determining study eligibility. A copy of the procedure is attached."

In most compliance cases, this CAP will suffice, Gaudreau says.

"Generally, the clinical coordinator and principal investigator and study team work out the CAP on their own, and it's generally acceptable," she says. "In cases where violations or events are more major in nature, the IRB or the QA staff will work with the principal investigator to make sure it's a comprehensive plan."