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Thread-Topic: Reviewing the first SOPs
Thread-Index: AcW5NNgmJdFqsyb9R6eFd6RwaTvxXgAV0j6AAAgxAvA=
Message-ID:  <[log in to unmask]>
Date:         Wed, 14 Sep 2005 21:38:27 -0700
Reply-To:     "Hwang, Yi-Cheng" <[log in to unmask]>
Sender:       "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv"
              <[log in to unmask]>
From:         "Hwang, Yi-Cheng" <[log in to unmask]>
Subject:      Re: Reviewing the first SOPs

Hi Donna,

Your point is well taken, and I'd just like to echo what Scott had
mentioned:

1. It is not mandatory that the sites adopt and use the caBIG SOPs.
Sites have the option to review the SOPs and use them as a starting
point for developing their own SOPs. 

2. The existing caBIG SOPs were developed by domain expertise from both
the intra and extramural sites (we could provide the list of
representatives). Best efforts from multiple stakeholders have been put
into creating this initial set of SOPs.

3. The caBIG SOPs are designed to be technology/tool neutral and written
at a high-level to focus on defining what must be done. The procedure
descriptions and workflows, which may be customized to meet each site's
specific approach, describes the specifics on the how. 

4. In fact, the caBIG SOP "AD001_PD_Develop_and_Maintain_SOPs" specifies
the annual review procedure for the SOPs.

The revision and review of SOPs is definitely an important topic, I
think we should revisit this topic in our next SIG call.

Thanks, Andrea
______________________________________________________
Yi-Cheng (Andrea) Hwang
Programmer Analyst
Chao Family Comprehensive Cancer Center
University of California, Irvine
714-456-2226 voice
714-456-5039 fax
[log in to unmask]
http://www.ucihs.uci.edu/cancer/

-----Original Message-----
From: caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv
[mailto:[log in to unmask]] On Behalf Of Finley Scott
Sent: Wednesday, September 14, 2005 5:36 PM
To: [log in to unmask]
Subject: Re: Reviewing the first SOPs

Donna-
Of course you are welcome to review the SOPs.  I'd strongly recommend
doing that first.  If you find fundamental problems, your insights will
be helpful indeed.  If you find something that's almost right for your
purposes, it just makes good sense to adapt it.  In any case you are
under no obligation to do anything with them at all.

The existing SOPs were developed with a well-managed process that pulled
in the key representative expertise needed to jump-start what is a very
challenging activity.  The people who contributed to that effort have
earned our gratitude through their hard work.  The SOPs are a gift to
the community from that group, and I urge us all to treat them
accordingly.
  --Scott


Scott Finley, MD, MPH
caBIG(TM) CTMS Workspace
Booz Allen Hamilton
410-908-9800 (Cell)
[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 Marlatt
Sent: Wednesday, September 14, 2005 9:50 AM
To: [log in to unmask]
Subject: Reviewing the first SOPs

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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