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Case series are especially vulnerable to selection bias; for example, studies that report on a series of patients with a certain illness and/or a suspected linked exposure draw their patients from a particular population (such as a hospital or clinic) which may not appropriately represent the wider population.
A retrospective cohort study, also called a historic cohort study, is a longitudinal cohort study used in medical and psychological research. A cohort of individuals that share a common exposure factor is compared with another group of equivalent individuals not exposed to that factor, to determine the factor's influence on the incidence of a ...
Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. The supervising Institutional Review Board (IRB) oversees the release of any personally identifiable data to the sponsor.
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An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB ...
An institutional review board (IRB) is a type of committee that reviews human based bio-research. Under 45 C.F.R 46, each IRB that is designated by an institution must be registered with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services (HHS). When registering an IRB, the following information must ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.
The PRISMA flow diagram, depicting the flow of information through the different phases of a systematic review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care ...