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Compliance office gives PIs audit preparation sheet
'Knowing you're about to audited can be scary'
Compliance officials can call principal investigators (PIs) and let them know about a scheduled audit, but chances are the site will be inadequately prepared for an efficient audit visit.
One solution is to send PIs a letter that details what will be happening and what the audit specialist needs to complete the oversight visit.
Columbia University of New York, NY, has a one-page audit preparation sheet that explains what the compliance oversight team needs the site to do for the audit, says Jessica Randall, MA, CIP, an audit specialist at the Columbia University IRB.
"For most investigators knowing that they're about to be audited can be a scary experience, whether it's for-cause or not-for-cause," she adds. "So this sheet lets them know what to expect, including the space we'll need, who the auditor will be, the information the auditor will need, such as regulatory binders, subjects binders, and names of everyone enrolled in the study."
The goal is to develop trust and help investigators and clinical trial coordinators prepare for the audit visit, Randall says.
"We make sure everything is taking place in accordance with regulations," she says.
Since Randall began using the audit preparation sheet, she has seen improvement in site preparation for audits.
"People can reference the audit preparation sheet, and it's easier for us to hand them this than to have to explain everything over the phone," she says. "There is no ambiguity, and we know they can contact us if they have any questions."
Here are some features of the audit preparation sheet:
It requests PIs and clinical research staff to have these items ready for the audit:
- Space, including seats and table, for one or two audit specialists for a four-hour block of time in a private area near study files;
- Access to a coordinator or study team member who has intimate knowledge of the research study under audit;
- Fifteen minutes of the PI's time at the beginning of the audit to go over the scope of the audit and to answer any questions the PI may have;
- A copy of the enrollment log for the audit specialist to use. This would include a list of all subjects enrolled and their study ID number, including those who were screen failures, excluded, or dropped out;
The form lists a sample of items the compliance oversight team will need easy access to, including these:
- Regulatory binder;
- IRB approval letters, stamped questionnaires, stamped consent forms, advertisements, and correspondence;
- Sponsor protocol and correspondence if applicable;
- Subjects charts, subjects signed consents, subjects signed HIPAA forms;
- Queries, monitoring reports and resolutions, outside audit reports.
For FDA studies, these also need to be made available:
- All FDA correspondence and FDA approval letters;
- IND/IDE paperwork;
- Drug logs, drug shipping logs;
- Sponsor correspondence;
- Data monitoring committee reports, if applicable;
- Investigational brochure;
- Monitoring visit reports.
The form concludes with a reminder that all correspondence from the audit, the subsequent report from the compliance oversight team, and the PI response should be filed in the regulatory binder at the conclusion of the audit.