ANVISA and the Importance of Inspections in Clinical Research
The National Health Surveillance Agency (ANVISA) is the main regulatory body for clinical research in Brazil, with the mission of ensuring the safety, efficacy and quality of medicines and health products. With an increasingly relevant role on the global stage, ANVISA has been expanding its monitoring activities, carrying out rigorous inspections at research centers, CROs (Contract Research Organizations) and clinical studies conducted in the country.
These inspections aim to verify compliance with Good Clinical Practices (GCP), ensuring that studies are carried out with the highest quality and safety for participants. For the pharmaceutical and biotechnology industry, compliance with regulatory standards is not only a legal requirement, but an essential part of the credibility of results and the success of new treatments on the market.
ANVISA recently released a report listing the results of its inspections and mentioning a number of non-conformities, revealing that many of the recurring problems could have been avoided with simple measures and a greater focus on quality control. Let’s explore 10 critical areas of non-conformity and how to mitigate these problems in clinical trials.
1. Task Delegation
Problem : Lack of adequate delegation and training for clinical staff.
Solution : Rigorously document task delegation and ensure all team members receive adequate and up-to-date training.
2. Training Documentation
Problem : Lack of training records for standard operating procedures (SOPs).
Solution : Implement a real-time tracking system that ensures staff compliance with mandatory training.
3. Data Discrepancies
Problem : Inconsistencies between source data and Case Report Forms (CRFs).
Solution : Perform periodic internal quality checks, comparing source documents with CRFs to identify and correct discrepancies.
4. Inadequate Monitoring
Problem : Lack of adequate oversight by sponsors or CROs, resulting in unresolved issues.
Solution : Create a regular monitoring system with ongoing review to ensure any issues are addressed and resolved immediately.
5. Errors in the Consent Form
Problem : Use of outdated versions or absence of participant consent form.
Solution : Establish a tracking system to ensure that only the most recent versions of consent forms are used.
6. Missing Approvals
Problem : Studies conducted without necessary ethical or regulatory approvals.
Solution : Adopt a pre-study checklist that ensures all necessary approvals are obtained before the study begins.
7. Inadequate Data Management Systems
Problem : Failures in unvalidated data systems, resulting in inadequate data management.
Solution : Validate all data management systems before studies begin and revalidate them whenever there are updates.
8. Temperature Excursions
Problem : Lack of control over temperature excursions during drug transport.
Solution : Use temperature monitoring devices with real-time alerts to ensure medications are transported under proper conditions.
9. Equipment Calibration
Problem : Measuring equipment not properly calibrated, compromising data accuracy.
Solution : Perform regular calibration of all equipment and keep an up-to-date record of these activities.
10. Failure to Report Adverse Events
Problem : Adverse events not reported correctly, putting participant safety at risk.
Solution : Establish clear procedures for reporting adverse events, with regular training for responsible staff.
The Tip: Don't Underestimate What Seems Trivial
Looking at these nonconformities, it’s easy to think that many of the issues are trivial or easy to fix. However, these failures are the ones that most often result in study interruptions, rework, and even data rejection by ANVISA or other regulatory agencies.
The key to ensuring the success of a clinical trial is not to underestimate the impact of these seemingly simple issues. Small lapses in quality control can turn into major problems over time. The key here is to implement a robust internal control system that prevents discrepancies and ensures compliance at all stages of the study.
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