Compliance checklist grants review constancy

Key is to provide comprehensive structure

The regulatory compliance office at Children's Medical Center of Dallas, TX, has developed a comprehensive, 14-page research compliance checklist that is used to review all studies.

Research compliance is involved, complex, and must follow numerous rules and regulations, so it's helpful to have a checklist for compliance staff to follow, says Barry Rosen, JD, ARM, CHC, CHRC, manager, regulatory compliance, Children's Medical Center in Dallas.

"We had to come up with a list as an objective way to review each clinical trial," Rosen says. "We have reviews that cover multiple trials, but that are focused on narrow issues, and so we'd use elements of the checklist."

The checklist used by the compliance department of Children's Medical Center is in a table format. It's very comprehensive with 17 elements related to informed consent, for instance.

Here are some sample items on the checklist, under the billing section:

  • Is this a qualifying clinical trial?
  • Are the items and services routine costs?
  • Are the routine costs reasonable and necessary? (i.e., does Medicare generally cover the services outside a clinical trial?)
  • Were repeated orders entered according to study plans to ensure correct charging (to the study or to the patient)?
  • Were reviewed charges for study procedures properly accounted?
  • If reviewed charges were incorrectly allocated, were corrections made in a timely manner and the cause of the error addressed?
  • Is the study an Approved Clinical Research Study (ACRS)—a study during which billing to Medicare is allowed? Medicare billing rules: Drugs: Clinical Trial Policy (NCD 310.1) Devices: device trial regulations and chapter 14 of the Medicare Benefit Policy Manual. Procedures: deferred to local Medicare Administrative Contractor. "Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered... these services include all services furnished in preparation for the use of a noncovered device, services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related noncovered services." 42 CFR 405.207(a).
  • Is the device being studied as a "covered device?" Yes: Routine services may be covered. No: Nothing required by study is covered.
  • What type of device trial is being studied:

–Non-FDA approved with no IDE
–IDE Category A devices (when studying a life-threatening condition)
–IDE Category B devices (when Medicare contractor approves coverage)
–HUD/HDE (Humanitarian Use Device/Humanitarian Device Exemptions)
–Post-marketing approval FDA-required studies
–On-label use of FDA-approved device
–Off-label use of FDA-approved device

  • Were reviewed research charges billed to the research account as outlined by the study protocol?
  • Were any stipends paid to the patient during the study? (Policy #7.46 Paying Patient Stipends)

Obviously, the elements related to device trials do not apply to studies that involve no devices. But the checklist's chief asset is that it can be applied in general ways to all trials, Rosen says.

"This provides consistency in reviews and helps us document our papers with exactly what we found and didn't find," he says. "We have a way to show what we did to back-up our conclusions."