What is an Onsite Review?
QIP is available to conduct both domestic and international review of study documentation and/or participant files (i.e., Onsite Reviews) to ensure regulatory compliance, including protocol adherence, accurate record keeping, and appropriate informed consent process. After the review, QIP will provide corrective actions and offer quality improvement recommendations.
How do I prepare for an Onsite Review?
Our Onsite Review Process document provides information on what to expect during an Onsite Review. QIP recommends using the Regulatory Binder Template and Investigator Self-Assessment to guide your preparations. If documents are kept electronically, there is no need to print copies for the purposes of the Onsite Review. QIP is also happy to assist in organizing your files while onsite.
How long with the Onsite Review take?
Depending on the nature of the study your review may take up to a full day or more. We have found, however, that a typical review takes anywhere from 1-2 hours. When you schedule the Onsite Review, the QIP reviewer will be able to provide a better estimate of the time needed onsite.
Who needs to be present during an Onsite Review?
It is ideal for the PI and/or a designated member of the study staff (generally the person who maintains the regulatory documentation) to be available for the initial meeting (15-30 minutes) and afterwards to provide a brief orientation to the regulatory files.
The PI and staff do not need to be present for the document review, but there should be at least one study staff member readily available (in person or via phone) in the event that the QA/QI Specialist needs clarification or has questions.
At the conclusion of the review QIP staff, the PI and/or any applicable study staff present will regroup for a brief exit interview. This meeting provides an overview of the preliminary findings, including likely corrective actions and/or best practice recommendations.
Do I get a report after the Onsite Review?
QIP will provide a written report within approximately 2 weeks of the completed Onsite Review. The report will include any required corrective actions as well as best practice recommendations. This report does not become a part of the IRB protocol file, and is kept confidential, only available to QIP, the PI, and appropriate study staff. The only exception to this policy is if QIP finds potential serious or continuing noncompliance. Under these circumstances, QIP is required to report this to the IRB and is available to help the PI come up with a corrective action plan. Investigators may share the report with members of the study team and should feel free to apply corrective actions and best practice recommendations to other protocols.
I only keep electronic files, how do I prepare for my Onsite Review?
This is absolutely fine, and becoming the norm. When onsite, QIP will need to have access to those electronic files, whether it is via temporary access to a shared drive, RedCap, Dropbox, or SharePoint. Use of a department computer may facilitate this process. Alternatively, you can provide a thumb drive containing your electronic regulatory documentation and QIP will review it back at their office. There is no need to print any documents only for QIP’s Onsite Review visit.
Can I request to meet with someone to walk me through the IRB process and/or what I need to have in my regulatory files?
Yes, QIP offers many educational opportunities in including One-on-One PI/Study staff Orientation, as well as regulatory binder training. In order to request these services, complete the QIP Service Request Form and specify what training would be most helpful.
For QIP assistance, please contact Alyssa Speier.