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Message-ID:  <[log in to unmask]>
Date:         Fri, 16 Sep 2005 15:37:55 -0400
Reply-To:     "Dubman, Sue (NIH/NCI)" <[log in to unmask]>
Sender:       "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv"
              <[log in to unmask]>
From:         "Dubman, Sue (NIH/NCI)" <[log in to unmask]>
Subject:      Re: Reviewing the first SOPs
Comments: To: Deborah Collyar <[log in to unmask]>

I'm on my way out on vacation but I wanted to weigh in here. 

The SOPs were developed by the C3D user group, not NCI in a vacuum. We (the
C3D user group and NCI) thought that the work done has broader value/benefit
to the community which is why we brought them forward. 

As I said at the Face to Face meeting, the SOPs are neither mandatory nor
cast in stone. This is an opportunity to work together to develop what is
needed for the caBIG community as a whole. 

There are procedures that the C3D group used to vet proposed SOPs and we can
start with those and modify them as the new group sees fit. There are also
processes used by the C3D group to finalize SOPs and we can start with those
and modify them as the new group sees fit.

Let's all try to work together here for the good of the whole.

Thanks very much,

Sue

-----Original Message-----
From: Deborah Collyar [mailto:[log in to unmask]] 
Sent: Friday, September 16, 2005 10:59 AM
To: List CABIG_CTMS_BPSIG-L
Subject: Re: Reviewing the first SOPs

 

-----Original Message-----
From: Deborah Collyar [mailto:[log in to unmask]]
Sent: Thursday, September 15, 2005 10:33 AM
To: [log in to unmask]
Subject: RE: Reviewing the first SOPs

Greetings,
This exchange has pointed out the reason why we need clear, understandable
procedures and communication if caBIG is to truly create a community which
develops standards that all need to use.

Both sides are seeing this from their own viewpoints, and we need to build a
common understanding so that future misunderstandings are kept to a minimum.
I suggest we proceed with some of these thoughts in mind:

1. It would be good to see the list of people who developed the SOPs to
date.  No one is questioning their good intentions, and in fact, they
deserve recognition for the work already done.
2. Setting up a procedure to vet the proposed SOPs throughout the BP SIG (or
possibly the wider CTMS or caBIG-wide community) is also important, and
needs to be done with reasonable timelines in mind.
3. A process on how SOPs will be finalized (with appropriate notice to the
caBIG community) should be clearly developed and described for all caBIG
members.
4. If the SOP of SOPs is to be effective, it may very well need to be
adopted by all caBIG members to set a consistent standard.  The key will be
to produce something that is broad enough to allow institutional variations
while providing a framework that everyone can understand and use.
5. The SOPs may need to be approved by the Strategic Planning WG (or
whomever has been set up as the peer review approval mechanism for caBIG) so
they can be used as a standard by all caBIG members.
6. Donna's points are valid and need to be resolved before going beyond the
BP SIG so that FAQs, etc. can be developed.

Thanks for listening,
Deborah

Deborah Collyar
President
PAIR: Patient Advocates In Research
925/736-8155
925/736-2836 fax
[log in to unmask]

-----Original Message-----
From: caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv
[mailto:[log in to unmask]] On Behalf Of Donna S. Marlatt
Sent: Thursday, September 15, 2005 9:25 AM
To: [log in to unmask]
Subject: Re: Reviewing the first SOPs

Now that I can open and review the SOP's, I see that these SOPs were
developed by the NCI staff? So does that mean anything written by NCI is
automatically caBIG-approved? Is that correct in thinking this? I guess I
didn't hear in the teleconf that the SOPs were written by NCI staff. 

Donna

********************
Donna Marlatt
Senior Programmer - BioInformatics
Clinical Trials Management
NCCC-Dartmouth
Lebanon, New Hampshire, USA
(603) 650-3413
[log in to unmask]

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