What are competing research studies?
Competing studies typically occur when two or more studies have substantially the same inclusion/exclusion criteria so that many patients will qualify for enrollment in each of the studies.
What are investigator initiated studies?
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 in research?
Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and …
What is competitive enrollment clinical trials?
competitive enrollment. When sites may enroll as many subjects as they wish until the overall study enrollment goal is achieved. cumulative enrollment. Current enrollment as well as any ever-enrolled subjects who have ended participation. current enrollment.
What is 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 is an ISS study?
Investigator Sponsored Studies (ISS) and ISS Sponsor. An ISS is a clinical study that is initiated, developed, designed, and conducted by a qualified sponsor external to Amgen who assumes sole responsibility for the conduct of the study. An ISS can take a variety of forms.
Why is investigation important in research?
The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent.
How is research different from investigation?
is that investigation is the act of investigating; the process of inquiring into or following up; research; study; inquiry, especially patient or thorough inquiry or examination; as, the investigations of the philosopher and the mathematician; the investigations of the judge, the moralist while research is (uncountable …
What is investigator of clinical study supervises?
Investigators are responsible for supervising the proper handling, administration, storage, and destruction of investigational agents (ie, drug accountability). Although these tasks can be delegated to an appropriately qualified individual, the investigator maintains ultimate responsibility.