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Avoiding the Pitfalls when Completing a CRF

In the world of clinical trials, the concept of a CRF is a well-known phenomenon. According to ICH Topic E6, a CRF is "a printed, optical or electronic document designed to record all the protocol requirements to be reported to the sponsor on each trial subject". This definition implies the importance of completing a CRF correctly, as incorrect completion will lead to a misrepresentation of the data of a clinical study, since it is the means of complete data gathering during the trial.

Data collected in a CRF normally include data on the subject/patient, (including demographic and medical history), study drug admission (such as time, dose and method of administration), and the outcome of assessments as described in the protocol and full safety monitoring (adverse events, their seriousness, countermeasures and relationship to drug, for instance). It is of prime importance that these forms be completed correctly as to reflect a true picture of the trial procedures and findings.

Although the CRF is only completed during the clinical trial, its inception is much earlier. Shortly after protocol design, the CRF is drafted and finalised following protocol approval and permission to perform the trial. It can not be stressed enough that when a CRF is being designed, careful attention should be paid to the way provision is made for data capture during the clinical phase. If a CRF is well-designed and its instructions are user-friendly in layout, the correct completion of this important document is effortless and already, many potential errors can be averted.


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By Cornea Venter, Senior Data Manager, Biometry Division, and Daleen Krige, Medical Writer, Biometry Division, at FARMOVS-PAREXEL

Cornea Venter joined FARMOVS-PAREXEL in 1996 as a Statistical Programmer in the Biometry Division. In 1999 she accepted the position of Data Manager and was promoted to Senior Data Manager in 2001. She holds an Honours degree in Computer Science and has attended several conferences and workshops.


Daleen Krige joined FARMOVS-PAREXEL in 1995 as a Medical Writer in the Biometry Division, after teaching at several education institutions. She holds a Masters degree in Communication Science and is presently researching for a PhD. She attended two European Medical Writers Association (EMWA) conferences in 1996 and 2000.

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Cornea Venter
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Daleen Krige
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