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Date:         Tue, 27 Sep 2005 17:23:40 -0400
Reply-To:     Jieping Li <[log in to unmask]>
Sender:       "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv"
              <[log in to unmask]>
From:         Jieping Li <[log in to unmask]>
Subject:      Re: Confusion about purpose of BPSIG and the SOP WG
Comments: To: [log in to unmask]
In-Reply-To:  <[log in to unmask]>

Hi Paul,

We missed you at today's SOP working group meeting. We made some 
corrections the SOP charter draft (see the updated one as attached). 
That may help you clear some of the confusions.

Thank you for your comment on the e-lab loading work flow. This work 
flow is one of the accompanying documents for SOP#IT-003 SOP for 
Electronic Loading of Lab Data. As we stated (today, see the attached 
presentation), SOP is written at high level and is not modifiable by the 
local site, however, the accompanying procedures can be modified to 
support local activities.  This accompanying work flow was developed 
when we were C3D user group, so it is for the C3D application users. 
However, if you have different application which needs lab loading 
process, you can follow the SOP with your modified version of the 
procedure and work flow.

Please let me know if that answered your questions.
Thanks.
Jieping


Paul K. Courtney wrote:

> 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
>


SOP WG Charter Draft_modified.doc [application/msword]

SOP Working Group Kick Off Presentation.ppt [application/vnd.ms-powerpoint]

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