Standard operating procedures clinical trial documentation

In summary, for data to be useful in clinical trial analyses they need to be quantifiable. The data must be either a continuous measure or a categorical value. Free text poses a problem for analysis, and if it is a valuable variable for the statistical analyses it really must be coded. Finally, hardcoding should be used only when absolutely necessary, because it is inherently problematic. Organizations that do allow hardcoding should document in their standard operating procedures (SOPs) that it is an approved business practice and how it is to be used. 

In case of use date extension an additional label should be affixed to the investigational medicinal product. This additional label should include the new use date and repeat the batch number. It may be superposed on the old use date, but, for quality control reasons, not on the original batch number. This operation may be performed on site by the clinical trial monitor(s) or the clinical trial site pharmacist, in accordance with specific and standard operating procedures and under contract if applicable. The operation should be checked by a second person. Documented evidence of this additional liability should be available in the trial documentation and in the batch records. 

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