The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.
According to the FDA regulations, an investigator--in this case the Menninger defendants --is defined as "an individual who actually conducts a clinical investigation...." On the other hand, a sponsor--in this case Aventis--"does not actually conduct the investigation unless the sponsor is a sponsor-investigator." All of the duties alleged by plaintiffs in this case fall within the purview of the Menninger defendants as the investigator conducting the M100907 study; the duties do not rest with Aventis.
The court notes that Aventis was not acting as a sponsor-investigator in this case.
Estate of Isner ("Darke"), the court also held that the sponsor is not responsible for the care of the patient because, again, the sponsor does not conduct the trial unless they are a sponsor-investigator. No.
"Sponsor-Investigator" means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.
FDA recommends that IRBs pay special attention to an investigator's qualifications where the study involves a sponsor-investigator, a study that is outside of the investigator's area of expertise, and/or any study design features that may significantly increase risks to subjects.
On September 10, FDA announced the availability of a related final guidance document intended to assist IRBs, clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an IND.
For each topic, the guide refers to regulations in the European Union, responsibilities of the sponsor-investigator
, hints and tips, and forms and templates.