Final answer:
A PI must comply with EMA and FDA regulations to use an EDC system in clinical trials, including following the EMA's guidance for human trials and submitting an IND application to the FDA. Post-approval, pharmacovigilance is required through Phase IV trials or other FDA-mandated safety surveillance efforts, with a strong focus on participant privacy and safety.
Step-by-step explanation:
In a clinical trial, a Principal Investigator (PI) needs to comply with specific regulations to use an Electronic Data Capture (EDC) system, such as the guidelines provided by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the United States. The EMA's Note for Guidance on Non-clinical safety studies outlines the necessary steps for the conduct of human clinical trials and marketing authorization for pharmaceuticals, including the ongoing post-marketing surveillance. Similarly, to receive FDA approval for a new therapy, researchers must submit an Investigational New Drug (IND) application to the FDA's Center for Drug Evaluation and Research (CDER) and undergo a review period before clinical trials can commence.
After a new drug is approved and reaches the market, pharmaceutical companies are mandated to carry out pharmacovigilance activities to monitor long-term safety and specific patient subgroup effects. This is often achieved through Phase IV clinical trials or other risk management plans required by the FDA. Additionally, researchers are tasked with ensuring participant privacy and safety throughout the clinical trial process, which includes obtaining informed consent from all participants.