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Message-ID:  <[log in to unmask]>
Date:         Tue, 27 Sep 2005 11:36:56 -0400
Reply-To:     [log in to unmask]
Sender:       "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv"
              <[log in to unmask]>
From:         "Paul K. Courtney" <[log in to unmask]>
Subject:      Confusion about purpose of BPSIG and the SOP WG
Comments: To: [log in to unmask]

[multipart/alternative]

All,
I'm writing this in hopes of either receiving some clarification about 
the objectives of this group and/or initiating some 
conversation/discussion about them.  First of all, though, I'd like to 
say that it is clear that the C3DS User Group has done a tremendous 
amount of work on detailing all of these work products and that none of 
what I say is meant to detract from that at all.

I've read through the Issued SOPs and the SOP WG Charter Draft 
document.  It seems to me that the SOP WG Charter document has an 
inherent inconsistency between two statements contained therein:

    *  From the Background:  The SOPs and accompanying documentation
      were designed and authored to be technology neutral 
    *  From the Objectives: Reach consensus on new SOPs and new business
      processes to enable efficient use of C3DS.

To me, being technology neutral implies that the CTMS being used is 
irrelevant.  But the objectives seem to point to a stated objective of 
the efficient use of C3DS.  Perhaps these are meant to be complementary 
statements?

I am also puzzled by the references in the Issued SOPs to the tight 
coupling that is assumed between clinical trials being conducted for NCI 
in the caBIG (TM) program and both C3DS and NCICB (see 
CR001_WF_Study_Setup.pdf for an example).  These are steps that would 
seem to be totally consistent with the use of C3DS but what about those 
many cancer centers who have their own CTMS's?  I can't imagine that 
NCICB is going to be involved in setting up access for new studies.  I'm 
also including a marked-up version of 
IT003_WF_Electronic_Loading_of_Lab_Data.pdf that indicates areas that 
seem to pull in NCICB quite a bit for application support.  If this is 
to be applicable to CTMS's in general, then it would seem we'll need to 
either make some of the SOPs C3DS-specific or re-engineer the current 
SOPs to be more general.

It may be that the presence of so much C3DS and NCICB language is due to 
the fact that this group began as a C3DS User Group.  In that context, 
all of these references make perfect sense.  I look forward to any 
replies.  I will not be able to attend today's teleconference, though. 

Paul

-- 
Paul K. Courtney, MS
Project Manager
Dartmouth/Norris Cotton Cancer Center
Lebanon, NH 03766
603-650-3403
http://www.cancer.dartmouth.edu


[text/html]

IT003_WF_Electronic_Loading_of_Lab_Data_Courtney.pdf [application/pdf]

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