Yale's QI self-assessment tool assists with better site compliance

It also helps with internal audits

Many clinical research institutions have limited resources for internal audits or quality improvement (QI) checks, so the key is to create proactive tools and policies to improve overall site regulatory compliance.

Yale University of New Haven, CT, has mastered this strategy through its creation of a quality improvement self-assessment tool and checklist.

There only are enough staff resources for about seven quality improvement reviews per quarter, says Tracy Rightmer, JD, CIP, compliance manager of the human research protection program at Yale University.

"So we focus on smaller, investigator-initiated studies, federally-funded studies, and others that are not industry-sponsored because those have outside organizations that monitor their activities," she explains.

The studies selected for audits are randomly chosen, based on criteria of greater-than-minimal risk.

The compliance office recommends that researchers improve their processes before a QI visit by completing a self-assessment tool. This tool also serves as a way to educate investigators and research staff on what is expected of them in terms of regulatory documentation, IRB documentation, subject recruitment procedures, informed consent process, subject selection criteria, adverse event reporting, drug/device dispensing accountability, and case report form source documents.

The regulatory documentation section includes references of specific regulations to which the questions pertain. Here are some examples of the self-assessment tool's questions about regulatory documentation:

  • Is the approved protocol (and consent) on file?
  • Is there a subject enrollment log? # of subjects included; # of subjects excluded.
  • Has the protocol been monitored by the PI or outside monitor as described in the protocol DSMP? Is there a monitoring log? How often is the study monitored?
  • Are all personnel who interact with subjects or their identifiable data listed on the protocol? Have all personnel completed the required HSPT and HIPAA training?
  • Is there a staff signature log? Is the staff signature log complete? Does the staff signature log include delegation of responsibilities?
  • Are lab tests required? Is a copy of normal lab values on file?
  • If eligibility or treatment decisions are based on test results or when study results are shared with subjects, are they done in a CLIA-approved certified lab?
  • Is there a COI on this protocol? If so, has the HIC management plan been adhered to?

The point of quality assurance visits is to help investigators and clinical research staff with their documentation and compliance, Rightmer notes.

"We give them an idea of what to expect during the visit, and this reduces some anxiety," she adds. "This is something we do to help them with the process and to work collaboratively to ensure all safeguards for the protection of human subjects are being followed."

The QA reviews are time-consuming and involved, but can be made easier for both the site and QA coordinator if the site has been conducting its own internal audits and monitoring. The self-assessment tool provides a simple structure for doing this. For instance, the self-assessment checklist gives investigators prompts on what is required in subject recruitment procedures, the informed consent process, and subject selection criteria. Here are the checklist questions for these three areas:

  • Are recruitment methods stated in the protocol?
  • Are approved recruitment materials (original and all revisions) on file?
  • Have changes to the recruitment materials been made since the last reapproval?
  • If yes, was an amendment submitted to the IRB?
  • How many versions of the consent form are there (i.e., how many times has the ICF been amended)?
  • How many different consent forms are being used in this study (e.g., healthy volunteers, adult subjects, minors)?
  • Provide the approval and expiration date for each version of the consent form.
  • Are all the original consent forms approved by the HIC on file?
  • List the subject files chosen for inspection (this may be a sample of subject files or all subject files).
  • Was any invalid consent form used?
  • If yes, was a protocol violation submitted to the IRB?
  • Did each subject or his/her [legally authorized representative] sign his/her own consent form?
  • Did each subject or his/her [legally authorized representative] date his/her own consent form?
  • Are there copies of enrollment notes written for each subject and kept in each subject's chart?
  • Did each subject or his/her [legally authorized representative] receive a copy of the signed consent form? Is subject's receipt of a copy of the signed consent form documented?
  • Is there an inclusion/exclusion criteria checklist?
  • Does each record indicate that the subject was included/excluded appropriately?
  • If subject was included inappropriately, was a protocol deviation submitted to the IRB?
  • Does the inclusion/exclusion criteria checklist for each subject include the dated signature/initials of the person obtaining the information?

Typically, CT sites receive a short report with recommendations following the QA visit.

"We'll provide them with templates with enrollment logs and inclusion/exclusion criteria checklists, and things like that," Rightmer says. "Depending on the findings, we will require corrective actions and a time line for completing those corrective actions."

There is a follow-up to make sure those corrective actions have been completed, she adds.