Open AccessClinical data acquisition standards harmonization importance and benefits in clinical data management
Author(s) -
Jagadeeswara Rao Gaddale
Publication year - 2015
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.167101
Subject(s) - harmonization , data collection , raw data , computer science , clinical trial , data quality , data science , electronic data capture , process (computing) , data management , data mining , medicine , engineering , operations management , statistics , metric (unit) , physics , acoustics , programming language , mathematics , pathology , operating system
In the clinical trial process, precise and concise data collection at the source is imperative and requires statistical analysis to be performed to derive the primary and secondary endpoints. The quality of raw data collection has a direct impact on the statistical outputs generated as per the statistical analysis plan. Hence, the data collection tools used for data transcription must be clear, understandable, and precise, which helps the investigator to provide the accurate subject data. Clinical Data Acquisition Standards Harmonization (CDASH) provides guidance to develop the case report form (CRF) for domains that are commonly used for the majority of the clinical trials across the therapeutic areas. This white paper describes the importance of CDASH standards, its advantages and its impact on the efforts and the cost in designing the CRF.