by Jill Cernohous, Senior Principal Advisor
Waiting until the end of a clinical study to start preparing for an FDA inspection can be disastrous. Early interventions allow issues to be addressed in real-time instead waiting until the end of a study. Implementing quality control measures to anticipate issues before they occur and identify and address issues in real-time can save money, minimize study delays, allow for better resolution of issues, ensure audit readiness at all times, and improve data integrity. FDA conducted over 1,100 BIMO inspections in 2015 with 301 conducted by CDRH. Are you ready for an inspection? The time to start preparing for an FDA BIMO inspection is now regardless of the current phase of your study.
Consider the following as part of the quality control process to help ensure compliance throughout the life of a study.
- With what regulations does the study need to comply?
- Are individuals managing the study qualified to fulfill their roles, and is documentation on file to support their qualifications?
- Are there sufficient written procedures in place to ensure the study is conducted in compliance with the study protocol and applicable regulations? Do these procedures encompass all critical areas? Has compliance with these procedures been documented?
- Are all vendors qualified, and is there sufficient documentation to support their qualifications? Are there procedures in place surrounding vendor qualification and management?
- Does the study require registration on clinicaltrials.gov?
- Is site staff qualified to fulfill their roles and is documentation on file to support their qualifications?
- Are adequate site agreements in place and have financial disclosures been obtained and any potential conflicts of interest addressed?
- Is the study adequately monitored to ensure compliance with the protocol and applicable regulations, and are the monitoring activities, including close-out of action items, documented? Are instances of site non-compliance being sufficiently addressed, and is compliance being secured in a timely manner?
- Are sponsor and site audits being conducted early during the enrollment period to confirm compliance and adequate monitoring, and identify any potential issues?
- Are study-related documents being maintained in accordance with good documentation practices?
- Are test articles being adequately controlled and maintained under proper conditions with limited access, proper labeling, and accurate accountability records?
- Can the investigators demonstrate adequate oversight of the study at their sites? Can the sponsor demonstrate adequate oversight of the entire study?
- Are study personnel familiar with record retention requirements?
- Are sponsor and site audits being conducted to ensure sites are ready for potential FDA inspection?
- Are study personnel trained on what to do in the event of an FDA inspection?
- Are all sites closed and have all test articles been accounted?
- Has the trial master been file verified as accurate and complete?
Compliance is critical to any clinical study, and compliance planning should begin before the first subject is enrolled. In order to be successful and ensure a study meets regulatory requirements, compliance measures need to be incorporated at every step in the process.
RCRI expert advisor can assist with your clinical study compliance needs. Contact Samantha Thrun at email@example.com or 952-224-2260.