Improve quality control following expert suggestions

Independent IRB grows with quality

One of the most important services an IRB can provide is rapid turnaround on protocol reviews. The next most important service is providing quality documents, says the president of a large independent IRB in Austin, TX.

At least one IRB organization has achieved both services by incorporating quality assurance processes from the start to finish of the protocol review process.

"As we've grown, we've identified the need for a quality department, which is our regulatory compliance department," says Lynn Meyer, CIP, CIM, president and founder of IntegReview Ethical Review Board of Austin.

Meyer formed IntegReview in 1999, and in the last eight years it's grown from having one employee to having a staff of 30 full time employees and one part-time employee. Also, there now are four independent review committees, two of which were created for specific clients who submit a large volume of protocols on a weekly basis, Meyer says.

IntegReview recently received full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. in Washington, DC. And the company was one of three small business finalists for the Greater Austin Business Award for customer service.

The quality department's role is to perform quality assurance and quality control on all documents the IRB office handles, Meyer says.

"As a result of that, we've implemented a CAPA [corrective and preventative action] program, and through that program, as errors or oversights are discovered, we evaluate our processes to identify if we need to strengthen a particular policy or process," she explains. "Or if there isn't anything existing at this time, then we will need to create a process to strengthen our quality."

When an error or oversight is discovered, a CAPA report is created and it's reviewed at the monthly managers' meeting.

"At the meeting we determine whether or not it was handled appropriately, or if there is something more we can do to take action," Meyer says.

IntegReview also uses a variety of tools, forms, and checklists to assist in improving quality.

For example, the single site review process is summarized in a one-page flow chart that begins with these steps:

  • Submit IntegReview New Study Submission forms for single site studies; Submission deadline — Wednesday 12:00 p.m. Central Time;
  • Quality assurance performed;
  • Data entry;
  • Quality control;
  • Document distribution to board members;
  • Board review Tuesday evening;
  • Board action distributed to client within 48 hours of review…

"Any new study submissions are submitted to the senior quality assurance associate," Meyer says. "She goes through the document to ensure all questions are answered and that they're answered appropriately and that accompanying documents have been received and so on."

There are checklists for all documents processed at IntegReview, Meyer notes. (See sample quality control checklist.)

"Checklists are time-consuming, but it helps you keep on track," she says. "The checklists can vary up to a dozen pages for a new study admission form, and whatever quality assurance person performs the function will use the checklist."

Checklists usually are developed by the director of operations, using input from coordinators, and the regulatory compliance manager helps to maintain and revise documents, Meyer says.

"They're discussed at weekly staff meetings, and sometimes they are a work in progress," Meyer says. "We're forever changing our checklists."

The senior quality assurance associate checks for omissions and mistakes, following the checklist.

If there are missing pieces, the QA associate and her assistant follow-up on this, and all documents stay in the QA department until they're complete and ready to be assigned to an IRB, Meyer says.

One of the IRB's co-chairs is an IRB coordinator, who also is a voting IRB member, Meyer says.

The other board members are consultants to IntegReview, she adds.

After the protocol is assigned to a board, it goes to a team manager, who looks over the study with regard to its therapeutic area and whether the drug has been reviewed by IntegReview in the past, she says.

If the drug has been studied before, it's assigned to the same board that reviewed it previously, she notes.

The team manager assigns new studies to one of the boards, based on the members' knowledge and expertise. If the study review will require a scientific specialist, then there is a list of consultants who can be called to provide comments.

"Once a study is assigned to a particular board, the coordinator/co-chair notifies our client that the study is put on the agenda," Meyer says. "The co-chairs basically introduce themselves and say they will be the main contact for any future communications."

IRB members receive study documents prior to the meeting, and they are provided a checklist that will assist them with their review, Meyer says.

"This helps them stay on track and it helps them look for certain documents that need clarification," Meyer says. "They come into our facility for a meeting, and the first quality control point happens after the meeting."

An IRB assistant uses an overhead projector at the IRB meeting to show board members the informed consent form. The IRBs use a primary reviewer system, so one person is assigned the task of facilitating the study review, Meyer says.

After the IRB meeting, the coordinator/co-chair formats the document and looks at its pagination, putting headers and footers on the document.

"Then they give the document to someone in the regulatory department who will perform another quality control check, reading through the entire document to see if there are any questions and to use the protocol as a reference, Meyer says.

"Sometimes they find things in the consent forms that need to be changed to match the protocol, and these possibly were missed during the study review," she explains. "They're also looking to see whether our required wording is included, as well." (See sample required wording for informed consent forms.)

"We try to capture a wide range of situations," Meyer says. "For example, there are pregnancy precautions, and the quality control person is making sure those are included in the consent form."

IntegReview staff spent a lot of time working on the sample informed consent form, she notes.

"We wanted to make sure that all the basic elements were there and that it included the board's required wording," Meyer says. "We also need to be sure that consent forms are written below a ninth grade reading level, and sometimes that's a challenge."

IntegReview's staff will write an informed consent document for clients who choose to pay for the service rather than write or modify their own forms according to the IRB requirements, she says.

Once all the changes have been made, the document is sent to the client with a tracking feature so the client can see what was changed from the original document.

"They are receiving from us an approved document, and if they have issues with that, then they can request another review for an approval request to show what changes they'd like to have made," Meyer says. "The coordinators/co-chairs go through these requests because they can be processed quickly if they're minor and pose no additional risk to study subjects."

The final quality improvement process involves identifying errors and beginning a CAPA process.

"If we find a problem internally, it's during the quality assurance processs and it's not reported as an oversight," Meyer says. "If things are sent out to clients and there are errors or oversights, then it's reported, and a CAPA begins."

The staff find out what happened and what on the checklist wasn't followed. If the mistake was due to a process not being in place, then a new process is created to fill that gap, she adds.