Observational Study Model (Design)
The general design, describing the strategy for identifying and following up with participants during observational studies. Types of observational study models include Cohort, Case-control, Case-only, Case-crossover, Ecologic or community studies, […]
READ MOREObservational Study
A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but […]
READ MORENuremburg Code
International standard created in 1947 that emphasized the need for a sound scientific basis in research on human subjects, and the safety and voluntary consent of participants. (Pfizer)
READ MORENon-Inferiority Study
A study with the primary objective of showing that the response to the investigational product is not clinically inferior to a comparative agent (active or placebo control). (Pfizer)
READ MOREContracts: Non-Disclosure Agreement (NDA)
A non-disclosure agreement (NDA) is a signed formal agreement in which one party agrees to give a second party confidential information about its business or products and the second party […]
READ MORENew Drug Application (NDA)
An application submitted to the FDA for a license to market a new drug in the United States. (Pfizer)
READ MORENational Research Act
The United States passed the National Research Act in 1974, which required the establishment of Institutional Review Boards (IRBs) for all research funded entirely or in part by the federal […]
READ MORENational Commission of for the Protection of Human Subjects of Biomedical and Behavioral Research
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78) is generally viewed as the first national bioethics commission. Established as part of the 1974 […]
READ MORENot Yet Recruiting
The clinical study has not started recruiting participants. A type of Recruitment Status.
READ MORENo Interventional Arm
A group of participants that does not receive any interventions during a clinical study. One of several Arm types.
READ MORE