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A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Variety of microbiological samples. A laboratory specimen is sometimes a biological specimen of a medical patient's tissue, fluids, or other samples used for laboratory analysis to assist in differential diagnosis or staging of a disease process. These specimens are often the most reliable method of diagnosis, depending on the ailment.
An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.
Examples include—ORRESU, --ORNRHI, and—ORNRLO, all of which are variable qualifiers of—ORRES, and—DOSU and—DOSFRM, all of which are variable qualifiers of—DOSE. For example, in the observation, 'Subject 101 had mild nausea starting on Study Day 6,' the Topic variable value is the term for the adverse event, 'NAUSEA'.
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant. Return of results is particularly discussed in the field of biobanks , where a typical case would be that many members of a community donate biobank specimens for ...
The LOCF method allows for the analysis of the data. However, recent research shows that this method gives a biased estimate of the treatment effect and underestimates the variability of the estimated result. [8] [9] As an example, assume that there are 8 weekly assessments after the baseline observation. If a patient drops out of the study ...
A research study that follows over time groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and those who do not smoke) and compares them for a particular outcome. (NCI) Clinical trial protocol. A study plan on which all clinical trials are based.