This Way or That

One problem with auditing and monitoring is that there is too much inconsistency as to how things should be documented.  A prime example is with date formats.  All of the following are ways of documenting the ninth day of September in the year 2009: 

 9/9/09
 Sep 9 2009
 09 Sep 2009

 But which one is correct?  The answer is all of them, but only if every date in the source is in the same format (according to most auditors and monitors).  I actually have been asked by a monitor to correct date formats because they weren't consistent or because the sponsor provided source asked for the date in a different fashion.  I think something can be said for consistency, especially in raw data collection processes such as educating all investigators on one way of performing exams, but why should sites be slapped on the wrist because a coordinator one day decided to write the date in one format and the next day uses a different one?

 I like the variety, I believe it personalizes the original documentation and does not need a special explanation as to why there are differences in the way dates are formatted.  I believe that auditors and monitors should be concentrating on the bigger picture, not scrutinizing the difference between date formats to attempt to identify fraud (As a side note I would bet that if someone really wants to make up data, it probably won't become evident through differing date formats).  Just like with personalized initials on consent forms instead of simple block letters, the freedom to record different date formats is important to preserving the originality of original source documentation in clinical trials.  Unfortunately, this argument would  likely not hold water for most auditors because of the good ole' consistency card that would be played against the site.

The bottom line is that the majority of sites are doing their best to collect quality data for study sponsors, and differences in date formats are a result of individual people putting their individual stamp on a trial while collecting this data.  Until this is acknowledged universally regulatory authorities should consider implementing a standard date format to be used at all levels of clinical trials. While this would remove some individuality of clinical trials, it would at the very least give sites some definite ground rules and hopefully prevent some generally meaningless queries at the hands of a monitor or auditor.