Attributes of a Well-Designed case report form
Well- Referenced
An informative footer and header are some of the components of a case report form (CRF) that is well-referenced. A good footer or header contains information such as page number, date of printing, subject initials, subject ID, protocol number and sponsor ID. These pieces of information identify the CRF page in a unique manner.
All the CRF booklet's pages ought to be numbered sequentially. This assists in the identification of manual review and data validation queries. Where there is just a single cumulative log page or unscheduled assessment being printed, one can insert a sequence number in the footer so that the pages being photocopied can easily be sequentially identified. A CRF that is well designed in the case of data collection in a laboratory would capture all the essential parameters linking to the central laboratory. Where the study takes place in more than one center, a central lab can be made use of for analysis of samples and preparation of results in a data set that is ready for analysis. This ensures that transcription errors are minimized and the quality of the data maintained.
CRF Design Layout
At least three types of data exist: cumulative data, time-dependent data, and non-time dependent data....
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