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Clinical Data Acquisition
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Details
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems.There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.The ICH guidelines on Good clinical practice (GCP) use the term Case report form or CRF to refer to these systems 1 .
Weitere Informationen
- Allgemeine Informationen
- GTIN 09786130296506
- Genre Technik
- Editor Frederic P. Miller, Agnes F. Vandome, John McBrewster
- Sprache Englisch
- Anzahl Seiten 56
- Herausgeber Alphascript Publishing
- Größe H3mm x B220mm x T150mm
- Jahr 2010
- EAN 9786130296506
- Format Fachbuch
- ISBN 978-613-0-29650-6
- Titel Clinical Data Acquisition
- Untertitel Clinical trial. Electronic data capture, Case report form, Good clinical practice, Clinical Data Interchange Standards Consortium, Clinical data management system
- Gewicht 92g
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