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Message-ID:  <2840282.1126709813708.JavaMail.www-data@c005>
Date:         Wed, 14 Sep 2005 07:56:53 -0700
Reply-To:     Norman Goldfarb <[log in to unmask]>
Sender:       "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv"
              <[log in to unmask]>
From:         Norman Goldfarb <[log in to unmask]>
Subject:      Re: Reviewing the first SOPs
Comments: To: Donna Marlatt <[log in to unmask]>
In-Reply-To:  <[log in to unmask]>

SOPs are normally reviewed on an annual basis, at least in theory. More frequent reviews increase the administrative and training burden, and cause confusion among people (who presumably exist) that are trying to follow them. 
  
Personally, I prefer a process where there is an operational version that changes infrequently and a draft version that changes on an ongoing basis, even including optional variants and open questions. (Statutory vs. case law) If enough changes develop in the draft, a new operational version can be published before the year is out. 
  
The more high-level the SOP, the more stable it is likely to be. If the contents are so high level as to just be truisms, it doesn't need to change at all, or, for that matter, exist at all. SOGs ("Standard Operating Guidelines", a rather forced name) include the operational details, which are much more fluid and useful in day-to-day practice. "There are many rooms in the house of SOPs, and the furniture is always changing." 
  
Since caBIG SOPs play both an operational, stamp-of-approval role and a model SOP role (people use them to create their own), we need a dual approach. 
  
MAGI, the Model Agreement Group Initiative, has updated its model clinical trial agreement every two weeks for about a year, and that's a 50-page, very complex document. (http://www.firstclinical.com/magi/documents/documents.html) 
  
"The Myth of the SOP", Aliah Blackmore, Quality Assurance Journal, 2004; 8,3-12 discusses the hows, whys and whats of divergence of SOPs from actual practice.  The article argues, among other things, that constant updating is required or SOPs become irrelevant. 
  
My article -- "Something for Everyone: Standard Operating Procedure Products for the Investigative Site" -- includes a discussion about why SOPs are a good for us. (http://www.firstclinical.com/resources/SOP%20Review.pdf) 
  
Norm 
  
_______________________________________________ 
Norman M. Goldfarb 
Managing Partner, First Clinical Research 
Chairman, MAGI, the Model Agreement Group Initiative 
Editor, The Journal of Clinical Research Best Practices 
Chairman, Clinical Research Relief Organization 
[log in to unmask] - http://www.firstclinical.com/ 
T 650.465.0119 - F 650.618.0359 
"Clinical Research Best Practices Consulting" 
  
  
-----Original Message from Donna Marlatt <[log in to unmask]>-----
  
Hello All- 

Yesterday during the first Best Practices SIG teleconference, John Speakman 
asked the question if the BP SIG can review the current 40-something draft 
SOP's before their actual release in September. I remember the answer being 
that we can look at them, but that the details of the SOP's will not be 
revisited, therefore, they are pretty much finalized waiting to be 
published. I feel uneasy with that answer as a community member trying to be 
involved with this process. It just makes sense as a "community effort" to 
have domain experts take a look at what has already been done and at least 
have the opportunity to discuss if need be. If there are no discussions 
after a certain time, then there aren't any changes that need apply? A 
discussion only means that whoever will be using these SOP's in the future 
may have the same questions and why not go ahead and clarify them right now? 
This is not re-hashing a process but I think a Best Practice in itself 
within the caBIG's strategic vision and goals regarding the community-based 
process. 

Is there a timeframe where publicly-released SOP's are reviewed, therefore 
allowing for revisions in the procedures as the domain experts see fit? 

Donna Marlatt 
NCCC-Dartmouth 

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