What are investigator initiated trials?

What are investigator initiated trials?

Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups.

What is an investigator sponsored study?

Investigator Sponsored Studies are defined as unsolicited research originating from an external sponsor entity, institution or organization and include studies also known as investigator sponsored trials (IST), expert initiated research (EIR) or any other term which may reference investigator-sponsored or investigator- …

What does IIT stand for in clinical trials?

When an investigator has an idea for a study they’d like to conduct, they may begin what is known as an investigator-initiated trial, or IIT. This article aims to provide a basic understanding of IITs and how they fit into the clinical research landscape.

Who can be principal investigator?

1. Who Can Be A Principal Investigator? The PI should be a staff of NHG or partner institution for research conducted in NHG or partner institutions.

What is IEC in clinical research?

IRBs can also be called independent ethics committees (IECs). An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants.

What is an investigator-initiated protocol?

What is an IIT? Also referred to as an investigator-initiated study (IIS) or investigator-initiated research (IIR), an IIT is a clinical trial in which the investigator conceives the research, develops the protocol, and serves as sponsor investigator.

Can you be a PI without a PhD?

My guess is that most agencies have no explicit rule that a PI must have a PhD, but that someone without one would have a much harder time making the case that they are qualified to supervise the research.

How many members are in the IRB?

five members
The IRB has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization.