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A mode to improve QI monitoring forms
Lacking IC form signatures is common finding
Research administrators often find that quality improvement (QI) monitoring reports elicit complaints from investigators or many questions about what the findings mean.
One research organization has worked to improve monitoring reports to reduce these problems by listening to what investigators want to read in such a report.
"We listened to feedback from principal investigators to make sure the reports and materials we use are clearer," says Anne Alberhasky, CIP, education and compliance specialist in the human subjects office at the University of Iowa in Iowa City, IA.
"We've learned from our investigators that the reports are long and the message in them was getting lost," Alberhasky explains. "So we moved some things around and changed things, such as moving our findings from the end of the reports to the beginning of the reports."
They made the findings brief and to the point, she adds.
"We have three columns in the table, and one is for the finding," Alberhasky says. "Another thing we learned from investigators is they want to know the basis of the findings, and so we have a column for policy reference, either university or policy regulations."
The column also refers to federal regulations, so the investigator will know which regulation the problem occurred in.
"The third column tells them what to do to fix the problem," Alberhasky says.
"We have set guidelines for some of the actions investigators need to take to remedy the situation, and we've come up with a template for handling them," Alberhasky says. "We've changed it from a wordy paragraph to a list of 'First do this and then do this.'"
Also, in most cases, PIs have to submit a modification plan, and compliance specialists find it wasn't accurately described, so this takes the guess-work out of it, she adds.
Negative feedback about QI monitoring reports have been greatly reduced since the form was revised, Alberhasky notes.
"Also, the responses that come in have been where they've done what they should do instead of our having to go back and explain what needs to be done," Alberhasky says. "We haven't gotten as many complaints from investigators or concerns about what they should do."
The reports, which are done electronically, range from four pages — for studies where there are few problems and no noncompliance — to 21 pages for older studies with more problems to report, she says.
The reports are sent as Microsoft Word attachments via email.
"We email the report to the investigator, and he responds through an on-line application system," Alberhasky says.
The entire monitoring report process is brief. Investigators have two weeks to respond, and most times they'll answer well before the deadline, Alberhasky says.