From the Research
The correct answer is A. Sponsor. The sponsor of an IND (Investigational New Drug) application is the entity that holds the application, typically the company, institution, or investigator who submitted it 1. In clinical research governed by Good Clinical Practice (GCP) guidelines, the sponsor takes responsibility for initiating, managing, and financing the clinical investigation. The sponsor has significant regulatory obligations including selecting qualified investigators, monitoring the investigation, ensuring compliance with protocols, maintaining accurate records, and reporting safety information to regulatory authorities. Unlike monitors (who oversee study conduct), study physicians (who provide medical oversight for participants), or partners (who may collaborate but don't hold regulatory responsibility), the sponsor bears ultimate accountability for the IND application and the clinical investigation it permits.
Some key points to consider include:
- The sponsor is responsible for ensuring that the clinical investigation is conducted in accordance with the protocol and regulatory requirements 2.
- The sponsor must also ensure that the investigation is monitored adequately, and that any adverse events are reported to the regulatory authorities in a timely manner 3.
- It's worth noting that the other options, B. Monitor, C. Study Physician, and D. Partner, are not correct because they do not hold the same level of regulatory responsibility as the sponsor 1, 2, 3.
It's also important to ignore evidence that is not directly related to the question, such as the study on exercise-based cardiac rehabilitation for coronary heart disease 4, or the study on the impact of Saccharomyces boulardii CNCM I-745 on bacterial overgrowth and composition of intestinal microbiota in diarrhea-predominant irritable bowel syndrome patients 5, as they do not provide relevant information to answer the question.