Attributes of a Well-Designed Case Report Form Essay

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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. The layout of the CRF design should be finalized after considering data review time, frequency, and also the CRF clustered level (Moon, 2006).

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Non-time dependent data: this is the kind of data that has been gathered at one point in time. Data like this includes medical history and demographics.

Time-dependent data: this is data that has been collected over a period of time. A good example of time-dependent data would be vital signs for an individual patient that have been recorded over several visits.

Cumulative data: this is data that has been collected over a period of time, without linkage to any particular visit. A good example is concomitant medications (Moon, 2006).

Organizing CRF Fields

CRF fields that are superbly structured and aligned give a clearer direction for the collection of data as well as for annotation of CRFs (Moon, 2006).

CRF Field Designs

CRFs that are well designed make use of different kinds of icons for various response formats. This is helpful in achieving data format consistency. They give a good picture of what investigators are expected to achieve and assists in ensuring that the data reported….....

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