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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.
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data ...
The term "Clinical research center" (CRC) or "General clinical research center" (GCRC) refers to any designated medical facility used to conduct clinical research, such as at a hospital or medical clinic. [1] They have been used to perform clinical trials of various medical procedures. The medical profession has had specific uses for CRC ...
Dichotomous, where the respondent has two options. The dichotomous question is generally a "yes/no" close-ended question. This question is usually used in case of the need for necessary validation. It is the most natural form of a questionnaire. Nominal-polytomous, where the respondent has more than two unordered options.
A research question is "a question that a research project sets out to answer". [1] Choosing a research question is an essential element of both quantitative and qualitative research . Investigation will require data collection and analysis, and the methodology for this will vary widely.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2 ] as:
A sample size of 10, i.e., polling 10 people, will seldom give valid polling results. Standard deviation and variance are concepts used to quantify the likely relevance of a given sample size . The placebo effect and observer bias often require the blinding of patients and researchers as well as a control group .
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