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Inclusion criteria may include factors such as type and stage of disease, the subject’s previous treatment history, age, sex, race, ethnicity. Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria ...
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 IB is a document of critical importance throughout the drug development process and is updated with new ...
Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration.
In qualitative research, a member check, also known as informant feedback or respondent validation, is a technique used by researchers to help improve the accuracy, credibility, validity, and transferability (also known as applicability, internal validity, [1] or fittingness) of a study. [2]
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial. (NCI) A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known ...
A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as ...
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For example, the Lecture Notes in Computer Science by Springer take much of their input from proceedings. Conference proceedings also get published through dedicated proceedings series as an edited volume where all their inputs comes from the conference papers. For example, AIJR Proceedings [1] [2] series published by academic publisher AIJR. [3]