Having supported DataFax for over 15 years, it sometimes looks as if SOPs are used as an excuse NOT to focus on Quality. If I am convinced of one thing, it is that SOPs are not a guarantee for Quality.
And the bigger the company, the more they rely on their SOPs. As if a SOP can avoid getting a corrupt database when an untrained user adds a new variable in the middle of a CRF page halfway data collection in a large study. Anybody who has been trained in Study Setup and done this pre version 3.9, will know its impact. SOPS usually document what SHOULD be done, not what you SHOULDN”T DO.
I guess it is the same with SOPs as with hotels. That is, the average person will not visit the kitchen of a four or five star hotel, nor will the average sponsor see all the details of a CRO handled study, nor will the average Auditor see all the details of a SOP governed trial at a Sponsor. As a matter of fact, in my role of Exhibitor at DIA meetings, I have seen kitchens of 4/5 star hotels, and to be honest, in most cases my appetite was not raised in any way. And no, I am not going to present any comment on what I have seen over the years at some DataFax sites.
Does this mean that SOPs are of limited use ? No, certainly not. They are certainly useful in documenting a best practice. I only think that sometimes the focus has shifted to much from user education to SOP adherence. And the only safeguard against ‘bad things happening’ is a well educated user, not a well documented SOP. At least, that is my perception.
