Clinical Research Coordinators And Pis

1240 WordsOct 24, 20155 Pages
clinical research coordinators and PIs are typically involved in this process. As the protocol is further developed, so are the CRFs. They are utilized to collect proper content of a protocol, presentation of insuring questions are asked properly to collect the proper data and the methodology of what design alternatives should be used and or avoided to minimize any problems associated with the study and the collection of data. Although there are standards to develop CRFs and collect data across all trials, there may be some situations that will require changes and therefore deviate from the norm. Demographics, vital signs, physical exams and lab data can all be removed from standard CRF data collection I order to meet protocol requirements. CRFs should always follow the Sponsor’s protocol in order to collect data as effectively and efficiently as possible. 2.3 Data capture, which is an accumulation of clinical data in a clinical trial, although may vary across different organizations, does have similar objectives when capturing the effectiveness and accuracy of data. Data that is captured in a clinical trial should represent all of the Investigator’s observations that have occurred with any given subject over the course of the study. Data entry in a study is usually single or double captured. When data is double captured, it increases accuracy due to two different entries but two operators. Data entry screens are an effective way of capturing double data. Once data is
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