Electronic databases can find trends more easily
Identify, track, make process changes
A well-conceived electronic database can make it possible for a quality improvement (QI) department to quickly identify and act on noncompliance trends.
Using a web-based electronic database system, the human research quality improvement program at Partners Healthcare of Boston, MA, has built a quality improvement review process that works quickly, efficiently, and is useful for finding trends.
"We can give investigators detailed data for self-directed improvements," says Sarah White, MPH, CIP, assistant director of the quality improvement (QI) program at Partners Healthcare.
QI specialists can show a group of investigators aggregate data on the most frequent noncompliance observations. Then investigators can compare this information with their own site's activities.
Also, the QI program can share trends of noncompliance with the institution's IRB office that can use it to look for ways the office's own policies and procedures could be restructured to reduce research site noncompliance.
For instance, the QI office might identify a trend of record-keeping problems that would generally not be reported to an IRB as noncompliance, but still must be corrected, White says.
"The IRB has guidance for those, and we'll look at the guidance to see if we need to define our audience a little better or push for more education at research sites," she adds.
One common trend is incomplete or inadequate study management practices. An example of this is when an investigator's curriculum vitae (CV), evidence of training, and qualification are not documented when required, White says.
"This is an administrative issue, but it reflects on the study's management success," she explains. "These types of observations generally are not reported to the IRB, but it's an issue that could lead to regulatory noncompliance in the event that someone is working on a study when they lack the necessary training and qualifications."
When QI specialists come across this type of incomplete paperwork, they will advise a site to improve their documentation of staff qualifications. If they see an observation frequently enough, they might ask the IRB to further clarify its guidance to ensure that investigators and study staff understand their responsibilities in documentation, she adds.
As a QI office reviews its database for trends, here are some questions that should be asked:
- Which sites are involved in this trend?
- Does the observation involve minimal risk studies or principal investigator-initiated studies?
- Do they involve drug or device studies?
- Who are the CR professionals having this problem and how can the QI office correct it?
- Would it help to send out email education to all CR sites?
- Should an educational workshop be created for specific research professionals or departments?
- Which systematic changes might be necessary?
- Which institutional policies could be changed to address this trend?
A standardized database makes it both possible and fairly straightforward to answer these sorts of questions about trends.
Most QI programs are moving in the direction of collecting metrics, identifying trends, and standardizing their data collection process, White says.
"The whole idea of having a standardized database is something most QI programs are thinking about now," she adds.