Sub-investigator

A sub-investigator (SI) is a member of the trial site personnel who works under the direction of the principal investigator (PI) to perform study-related procedures that require medical decision-making.

Co-investigator

The term co-investigator is not defined in FDA regulations. However, as commonly used it indicates that each co-investigator is fully responsible for fulfilling all the obligations of an investigator as identified in 21 CFR 312.60 . The term co-investigator can also be found in the glossary provided by the US National Institutes of Health (NIH) .

Definitions

ICH E6(R2)

1.56 Subinvestigator:

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows) .

Differences in regulatory requirements worldwide

United States (FDA)

A sub-investigator is considered part of the clinical investigation team. They must be listed on Form Form FDA 1572, which the PI submits to the FDA. Sub-investigators must comply with the same regulations and guidelines as the PI, including adherence to the protocol, GCP, and other regulatory requirements.

Under US regulations, any hospital staff who offer support or occasional medical care but do not significantly contribute to the clinical data do not need to be classified as sub-investigators  .

European Union (EMA)

The European Medicines Agency (EMA) refers to all members of the clinical trial team as “investigators”. The principal investigator is responsible for the overall conduct of the trial, but all team members, including (sub-)investigators, must comply with the EU Clinical trials Regulation and GCP guidelines.

The EU regulation does not acknowledge a distinct role titled “sub-investigator”.

Duties and responsibilities of sub-investigator

Sub-investigators share the responsibility of ensuring that the trial is conducted in accordance with the study protocol, good clinical practice (GCP), and regulatory requirements. A sub-investigator assists in various aspects of the study, which may include:

• screening and enrolling study participants
• obtaining informed consent
• conducting physical exams and assessments
• administering study drugs (or other interventions)
• following up of adverse events and adverse drug reactions
• monitoring study participant progress
• collecting and recording clinical data
• maintaining medical notes and other study documentation
• communicating with the principal investigator, other trial site staff, CRO or sponsor

Study coordinators vs sub-investigators

Responsibilities, regulatory oversight, and areas of focus of study coordinators (SC) and sub-investigators differ significantly. Generally, SCs manage the operational aspects of the trial, while SIs are involved in clinical decision-making and patient care under the direction of the principal investigator.

It is possible that roles of SC and SI beard by one ant the same person.

	Study coordinator (SC)	Sub-investigator (SI)
Role	The study coordinator (SC) focuses on the administrative and operational aspects of a trial.	Role of SI is more clinical and decision-making-oriented, involving direct patient care and significant input into the clinical aspects of the trial.
Regulation	SCs are typically not regulated directly by specific laws or guidelines. They are usually not listed on regulatory documents such as the Form FDA 1572.	SIs are regulated under specific guidelines and are considered part of the clinical investigation team. In studies under US regulation, they must be listed on Form FDA 1572.
Education / training	SCs usually have a background in healthcare, such as nursing, or a degree in a scientific discipline. They often complete training programs focused on clinical trial management, regulatory compliance, and GCP.	SIs are usually medical doctors or other healthcare professionals (such as doctors of osteopathic medicine or dentists) with advanced degrees. They receive extensive training in clinical research methodologies, regulatory requirements, GCP, and the specific therapeutic area of the trial.
Examples of duties / interaction	SCs manage the day-to-day activities of the trial. Their responsibilities may include: scheduling participant visits data entry (e.g. into CRF) coordinating with other study personnel managing study documentation and regulatory submissions	SI perform trial-specific procedures and make significant trial-related decisions. Their responsibilities include: screening and enrollment physical examinations study drug administration safety monitoring data recording (e.g. into source records) communicating with the pi and other study staff maintaining study documentation

See also

Another relevant pages

• Investigator

Links to this page

• Investigator ‎ (← links)
• Subinvestigator (redirect page) ‎ (← links)
• SI (redirect page) ‎ (← links)
• Trial site ‎ (← links)