Ensuring the safety of healthy volunteers and patients taking part in clinical trials is vital. Another essential component of clinical studies is data integrity. What are the primary ethical and regulatory guidelines (such as ICH and GCP) that CRAs and researchers must adhere to in order to preserve reliable data and safety? What role do CRAs monitoring visits play in these aspects?
Patient safety and data integrity are at the heart of clinical trials, and guidelines like ICH and GCP provide a framework to ensure both. These standards emphasize rigorous protocols, informed consent, and careful documentation, safeguarding participants and maintaining reliable data. CRAs play a critical role by conducting monitoring visits to ensure sites follow these guidelines, verifying data accuracy, and checking that any adverse events are reported and addressed promptly. Their oversight helps uphold both ethical standards and regulatory compliance, ensuring trial integrity from start to finish
