Wednesday, 11 January 2012

Good Documentation For Clinical Research


Good documentation practice in the clinical trial holds few credentials like accuracy, legibility and traceability. The document drafted in the clinical trial should tell the entire story in a readily understandable and standardized manner, and must contain all relevant information. The clinical trial document attains the credibility of legibility when it is read and understood by others. The data entered in the clinical trial document should be accurate and error free. The possibility of error in the clinical trial document can be reduced by recording the clinical trial proceedings immediately so that there will be a chance to recall the errors and correct it.

The traceability of the clinical trial document tells what is recorded? Who recorded it? Why it is recorded and when it is recorded? Clinical trial research documentation should include trained staff for the documentation process because it involves combining plenty unique documents into one.

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