Each year, FDA publishes their bioresearch monitoring (BIMO) inspection metrics from the previous year. Like clockwork, inspectional findings issued by the agency contain similar themes: failure to follow the investigational plan, inadequate monitoring, and issues with informed consent. Here are the top five from Investigator and Sponsor audits for 2021:
Common Clinical Investigator Inspectional Observations from FDA Form 483s (2021):
Failure to follow the investigational plan
Inadequate case history and study records
Inadequate investigational product control and/or accountability
Failure to comply with Form FDA 1572 requirements
Inadequate subject protection; informed consent issues
Common Sponsor Inspectional Observations from FDA Form 483s (2021):
Failure to maintain adequate records
Failure to select qualified investigators and/or monitors
Failure to ensure proper monitoring of the study
Failure to submit an Investigational New Drug (IND) application
Inadequate subject protection; informed consent issues
Source: BIMO Inspection Metrics | FDA
These observations can be avoided!
While monitoring is a part of Sponsor responsibilities (21 CFR 812.40, ICH E6 5.18.3), it is limited to ongoing reviews of the study conduct at the sites and is generally performed during enrollment and follow-up.
Even if you feel confident in your monitoring team, clinical audits can give added assurance that your study conduct is sound at the sponsor, site, and vendor (think core labs) levels. A clinical audit is a broad evaluation of the systems and processes of the trial and measures the effectiveness of the execution of these processes, including monitoring. An audit adds a quality assurance component to your study and demonstrates your dedication to compliance and Good Clinical Practice. Of course, no study is perfect, and identifying and resolving gaps in your documentation is better to be done before FDA calls. An independent auditor can help coach and prepare your team and your sites for an upcoming FDA BIMO inspection as well.
If you would like to learn more about how clinical auditing can help you achieve your study objectives, Bannick LLC is your experienced Clinical partner. Our Clinical Quality Services are tailored to help you achieve your goals. Contact us to learn more.
Recent Comments