Design of Case Report Forms

Oct 25, 2018 | 0 comments

Oct 25, 2018 | Miscellaneous | 0 comments

Design of Case Report Forms

Abstract

A case report form is a computerized or written tool mainly for clinical trials data collection. It assists in apprehending all procedural information by coordinators. A well-structured CRF simplifies the process of gathering and recording information data and provide assistances to relevant aspects of data control and arithmetical analysis. This essay seeks to discuss elements of a well-planned CRF and possible negative effects of developing unsatisfactory one to the clinical trials.

A well-designed CRF

A case report form (CRF) refers to a tool used to collect and record data in clinical trials in a procedural manner (Moon, 2006). The forms assist in the proficient management of information and arithmetical examination in a clinical database. A well-strategized CRF is an educational and organized numerical exploration, where the interpretation of electronic catalogue scheme (Koop and Mosges, 2002). It comprises footer and header that contains the decorum and page number, details of the sponsor, visit ID, subject’s information, form ID, and printing date (Marks, 2004). Page numbering in CRF occurs in a chronological manner for its quick recovery and database creation (Preston, 2009). The visit ID indicates the process of archiving statement in the records while form ID shows the connection between the CRF and the database. CRF encourages apprehending comprehensible, regular, and effective statistics that reduces record data errors.

Toto & McPhaul (2010) states that a poorly planned CRF especially whose scheme aims at recording the highest sum of fields in a single page can have a high cost of data management. Even the design helps to lessen the total cost of printing, it increase expenses in arithmetic analysis and query control. The complication of database plan increases in a case where a grouping of dissimilar collections of essential data occurs on a single page (Siegel, 2002). It also causes scatters in the CRF hence the illegibility of the data field and troubles of data entrance (Brody, 2011). The complications may raise several queries that required supplementary preparation of data before the analysis.

Reference

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