Sub-Investigators are healthcare professionals who assist the Principal Investigator (PI) in overseeing and conducting the study. While the Principal Investigator has the primary responsibility for the trial, sub-investigators help manage various aspects of the research, ensuring that the study is conducted in accordance with the protocol and regulatory requirements.
Key Responsibilities of Sub-Investigators
Assisting the Principal Investigator (PI)
Support the PI in managing and conducting the clinical trial. This includes ensuring that the study is carried out according to the approved protocol and that all procedures are properly followed.
Participant Care and Monitoring
Sub-investigators often have direct contact with study participants. They provide medical care, monitor participants’ health throughout the trial, and assess any symptoms or adverse events that occur.
Conducting Medical Procedures
Perform medical assessments, administer treatments, and collect biological samples (e.g., blood draws, imaging) as required by the study protocol.
Adverse Event Reporting
Identify and report any adverse events or side effects experienced by participants, ensuring that these are documented and managed according to the study’s guidelines.
Data Collection and Documentation
Ensure accurate and thorough documentation of all clinical trial activities. This includes entering data into case report forms (CRFs) and maintaining comprehensive medical records for each participant.
Ensuring Protocol Compliance
Sub-investigators help ensure that all study procedures adhere to the approved protocol, Good Clinical Practice (GCP), and any regulatory guidelines. They are responsible for maintaining the integrity of the study.
Communication with the Research Team
Work closely with the Principal Investigator, Study Coordinator, nurses, and other members of the research team to ensure that all aspects of the clinical trial are well-coordinated and properly executed.
Participant Education
Educate participants on the study procedures, potential risks, and expected outcomes, ensuring they fully understand their role in the clinical trial.
Sub-Investigators are critical members of the clinical trial team who provide medical expertise and support to the Principal Investigator. Their responsibilities include participant care, monitoring health, reporting adverse events, and ensuring the study is conducted according to the protocol. They play a key role in maintaining the quality and integrity of the clinical trial.