What are the primary responsibilities of an Investigator in clinical research?

The primary responsibilities of an Investigator in clinical research include patient management and ensuring study compliance. The Investigator plays a crucial role in overseeing the study and is directly responsible for the safety and well-being of the study participants. This involves obtaining informed consent, conducting assessments, and monitoring the patients throughout the trial to ensure they meet study criteria and that their rights are protected.

Additionally, the Investigator must ensure that the study adheres to regulatory guidelines and the protocol established for the research. This encompasses maintaining accurate records, reporting adverse events, and ensuring that all procedures are performed according to standard operating procedures and in accordance with Good Clinical Practice (GCP) guidelines.

While other aspects such as data analysis, sponsor relations, and regulatory submissions are important in the broader context of clinical research, they primarily fall under the responsibilities of Clinical Research Coordinators or other roles within the research team. The Investigator's central focus remains on the patients and compliance with the study protocols.