Diaries, electronic subject

Paper subject diaries are notoriously poor in their legibility, completeness and accuracy. Electronic diaries are small, portable devices that can present text and graphics to the subject. They allow the subject to record and store responses, which can be time-stamped for each entry made. 

Paper subject diaries are notoriously poor in their legibility, completeness and accuracy. Electronic diaries are small, portable de vices that can present text and graphics to the subject. They allow the subject to record and store responses, which can be time-stamped for each entry made. The data can then be downloaded directly into the clinical trial database. The main drawbacks include the need for training of the subject in the diary s use, possible errors in local time settings and the logistics of distribution, maintenance and recovery of the diaries. 

Obviously, if the clinical mirror approach to bioequivalency testing gains momentum, we may expect to see more quantification of clinical response in bioequivalency studies. In some instances pharmacodynamic parameters that are amenable to precise quantification are easily identified. Thus, if we are working with an antihypertensive drug, measurement of blood pressure using an electronic sphygnomanometer is an obvious option. However, for many drugs there is no simple way to quantify pharmacodynamic response. In some cases we may have to rely, to some extent at least, on patient diaries [41]. Such techniques are open to criticism of subjectivity and imprecision. 

Electronic Diary Cards are portable, hand-held systems designed to be programmed according to specific protocol requirements and are used by patients to record directly information on their condition and medication consumption during a particular study. They should be specified and designed so that they are highly prescriptive since they are used in a relatively uncontrolled environment (e.g., subject s home). Specific considerations for the validation of electronic diary cards are ... 

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