Research institution's QI checklist aids process

IRB provides hard stop

When IRBs and research organizations' quality improvement offices work together, the net effect is a more thorough and efficient human subjects research process, experts say.

The Emory Healthcare office of quality in Atlanta, GA, created a clinical trial readiness checklist that is completed by researchers at the beginning of a study, says Sarah Putney, JD, IRB director at Emory University in Atlanta.

The project was created after various clinical research stakeholders met to analyze and discuss ways to improve efficiency and safety, she adds.

While the IRB assesses the overall safety of a clinical trial, it's less attuned to the study preparation process, notes William A. Bornstein, MD, PhD, chief quality and medical officer at Emory Healthcare.

"This checklist is an attempt to create a linkage between the planned efforts and the reality and to see if the staff really knows about this trial," he says. "Do they know what kind of impact it will have on the laboratory and radiology and investigational drug services?"

The checklist is a collaborative effort between the QI office, the IRB, and the office of clinical research, Putney says.

"As with any good QI program it has to include hard stops," she says. "So the way it works is the IRB helps to educate study staff when they submit a new study for us to review."

IRB staff directs them to the checklist, which is listed on the website.

"The IRB tells the study team they need to complete this, and then we continue on with our regular protocol review," Putney explains. "The IRB can go ahead and approve a clinical study, but we won't release the validated consent forms and HIPAA forms until the office of quality says the checklist is complete."

If investigators have any questions about the checklist, they are sent to the office of quality.

"There are two ways to think of the checklist," Bornstein says. "It's useful to make sure researchers have done what they need to do, and it's also useful as a way to provide organizational controls around the way they get things done."

The checklist itself is a simple, one-page form in table format. It lists these items:

• Study title

• IRB #

• Principal investigator

• Clinical research coordinator

• Protocol orders:

— Clinical facility approval of study site feasibility; signatures by EHC executive

— Approved/PI signed protocol orders written and reconciled with study and care delivery team and delivered to applicable care areas; signatures by PI, pharmacist, clinical nurse manager, and CRC

— Clinical in-service to entire clinical unit for protocol; occurs after all orders are signed off on; CNS educated if applicable; signatures by clinical nurse managers

— Stakeholder ancillary services in-service (depending on study requirements); occurs after all orders are signed off on; signatures by PI, lab, radiology

• Education

— Protocol education and training provided to research team, including MD investigators, nurses, and CRCs; signatures by PI and CRC

• IDS

— The study has fulfilled IDS requirements? Signature by IDS pharmacist

• Billing/compliance

— The study has been received by OCR? Signature by OCR representative.

Each item on the checklist represents an accountability sign-off step in the process.

"The intent is to give investigators something they have to look at and say, 'I haven't done this yet,'" Bornstein says. "Behind each sign-off there's another checklist to make sure things get done."

For example, before the investigational drug service sign-off can occur, the investigator will have to complete the IDS checklist of tasks to be performed.

"The pharmacist's signature represents they've checked and made sure they're responsible for saying the study team is ready to go from their point of view," Putney explains.

The clinical trial readiness checklist and the hard-stop involving the IRB releasing the informed consent document and HIPAA form are a way to enforce responsibility and accountability along each step leading up to the initiation of a clinical trial.

The quality improvement office doesn't monitor all of the steps required before officials sign the checklist, but it is assumed that if someone signs the form then the investigator has meet all of their requirements, Bornstein says.