Improvement checklists help quality processes

Thorough, efficient human subjects research

When review boards and research organizations' quality improvement (QI) 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 created a clinical trial readiness checklist that is completed by researchers at the beginning of a study, says Sarah Putney, JD, institutional review board (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, Putney says. While the review board 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," Bornstein 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 review board, 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." Review board staff directs them to the checklist, which is listed on the web site. (For a sample checklist, see box, below.)

Clinical Trial Readiness Checklist

The Emory Healthcare (EHC) Office of Quality in Atlanta created a clinical trial readiness checklist that is completed by researchers at the beginning of a study. The checklist is a simple, one-page form in table format. It lists these items:

  • Study title
  • IRB number
  • Principal investigator (PI)
  • Clinical research coordinator (CRC)
  • 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; clinical nurse specialist (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

  • Investigational Drug Service (IDS)

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

  • Billing/compliance

— The study has been received by the Office of Clinical Resesarch (OCR),
—Signature by OCR representative.

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

"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.

Bornstein add, "There are two ways to think of the checklist. 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.

"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 (IDS) 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 hardstop 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.