Compliance Corner

IRB has CR sites correct errors with action plans

Key is prevent noncompliance

IRBs and research offices need a variety of procedures and tools to ensure compliance. One tool that sometimes is overlooked is requiring research sites to develop corrective action plans (CAPs) when they have problems.

"Often times the principal investigator and research staff want to do the right thing, and they don't want adverse events or violations to continue occurring, but they might not know how to create a corrective action plan," says Stephanie Gaudreau, CIP, IRB administrator for the Ochsner Institutional Review Boards at Ochsner Health Systems in New Orleans, LA.

The purpose of the plan is to reinforce the importance of internal controls to prevent harm to research participants, she notes.

"Going through the process helps them look at a root cause of a problem and address it," Gaudreau adds.

This is where an IRB office can assist.

"By having the corrective action plan come through the IRB office, it forces investigators to think about, report it, and respond to it," Gaudreau says. "Without the CAP, research staff might not take time to think about the root cause of the problem and how to fix it and do internal educating and communicating."

Gaudreau offers these tips on creating a thorough compliance process that uses corrective action plans (CAPs):

• Establish triggers for requiring a CAP: Research institutions that conduct post-approval monitoring audits can recommend CAPs from research sites that have had findings during these audits.

"We have an internal QA office that does for-cause and not-for-cause audits, and often times they'll go into a department and work with a specific principal investigator, finding a list of protocol violations," Gaudreau says. "The violations could be something we consider minor or others that are not minor," she adds. "For instance, we've had a few where the consent process was not carried out correctly, and the documentation for consent was not done correctly."

If this problem occurs just a couple of times, it could be seen as a minor violation. But in cases where it has occurred repeatedly, the IRB might see that as a compliance problem and would require a corrective action plan from the site, she says.

"We've also had some major issues where we may have had a study drug given outside its window, and that may have occurred with two or more subjects," Gaudreau says. "In that type of case we would definitely want a corrective action plan, and the requirements might be stricter: we might ask for follow-up data in 30 days and ask that the continuing review be submitted quarterly."

Another trigger for a CAP would be if a researcher is noncompliant in terms of submitting continuing review forms or has a large number of violations or events, she says.

"We may request the QA office audit some of their files, but this rarely happens," she adds.

Also, the CAP might be triggered involve reportable event reporting to the IRB and findings during continuing review. If there are trends, a pattern of violations or adverse events, then the IRB office will forward the information to the IRB chair and ask for advice on whether it should go to the full board for review, Gaudreau says.

"About 90% of the time the full board or chair will request an action plan," she says.

Any regulatory agency investigation that produces findings or warning letters would trigger a CAP, as well, she adds.

• The IRB makes the final CAP decision: "Sometimes the IRB chair will determine right away that it needs a corrective action plan before it goes to the panel," Gaudreau says. "Sometimes the chair will decide to wait and take it to the full panel, especially if we're trying to determine whether there's continuing or serious noncompliance."

The chair will wait for the full board to make a decision in those cases because the IRB also will have to report these events to other agencies, she adds.

When the IRB decides a corrective action plan is necessary, the IRB's electronic system sends out a formal notification from the IRB requesting corrective action plans.

"The letter provides a link to a sample corrective action plan and guidance," Gaudreau says. "We recommend they contact the IRB office for additional guidance."

• Provide guidance on creating CAPs: The IRB has a CAP form that lists the action the research site is going to take, the due date they expect the action to be met, and whose responsibility the action is plus any additional comments.

"It's not open-ended," Gaudreau says. "We want to see that they're addressing the problem and that there's a submission or end date and we can see who is held responsible in their team to make sure it happens."

The IRB office will suggest researchers check out the online materials, including a tool that outlines how to design corrective action plans for clinical research, she says.

"Education of the study team is key, so we always request they put that in the plan," she adds. "If the site's problem is addressed within the IRB's standard operating procedures or institutional policies, then they'll advise them to go to those policies and review them with their study team."

Ochsner's corrective plan guidance includes these six steps to writing effective CAPs:

1. State the problem or weakness succinctly, including the root cause.

2. Have "owners" who are accountable for results.

3. Break the solution into discrete, measurable actions that address the root cause.

4. Identify accountable person for each action.

5. Set achievable deadlines.

6. Monitor progress.

The Ochsner material also lists some items that the U.S. Food and Drug Administration (FDA) expects to see in corrective action plans, including these:

— Evaluation of the extent of the problem

— assessment of the root cause

— Any corrective actions, including plan to correct, implementation details, training, and assessment of the correction

— supporting documentation

— preventive actions to prevent recurrence.

The guidance material also lists nine helpful hints and provides a one-page sample corrective action plan based on the deficiency of having case report forms that are incomplete.

• Have the IRB review the completed CAP: First the IRB office staff review the plan to see if it is complete and contains the items the board would require.

"If something is missing we return it to them and pick up the phone to talk with the investigator or coordinator to give them specifics of what we're looking for," Gaudreau says.

Then the CAP is put on the schedule for the board's next review meeting. These CAP reviews last 10 to 30 minutes, depending on how serious were the events that triggered the plan.

"If it was a serious event that triggered the plan, then the board tends to focus on follow-up information so they will often request a follow-up to the CAP within four months or three months," Gaudreau says. "The follow-up could be a narrative from the principal investigator."

The PI needs to explain whether the CAP is working and how many people have been enrolled since the CAP was reviewed.

"It hasn't happened very often, but in some cases where participants may have potentially been seriously harmed, we'd request the follow-up data," she says. "Also at the time of continuing review, we'd look at the review and remind the panel of the corrective action plan and what the team was supposed to be following."

After comparing the CAP and the past year's events, the IRB would look for red flags that might need to be addressed by the board, she adds.