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Content-Type: text/plain; charset="us-ascii" Thread-Index: AcW6EkFwALy+QpSlQlqbIta1Ga0zzQAB5WTwAC1TZYA= Message-ID: <[log in to unmask]> Date: Fri, 16 Sep 2005 07:58:57 -0700 Reply-To: Deborah Collyar <[log in to unmask]> Sender: "caBIG(TM) CTMS Clinical Trials Best Practices SIG listserv" <[log in to unmask]> From: Deborah Collyar <[log in to unmask]> Organization: PAIR/CTIP Subject: Re: Reviewing the first SOPs In-Reply-To: <[log in to unmask]>-----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] ******************************************* Confidentiality Notice: This message is intended for the use of the person to whom it is addressed and may contain information that is privileged, confidential, and protected from disclosure under applicable law. If you are not the intended recipient, your use of this message for any purpose is strictly prohibited. If you have received this communication in error, please delete the message and notify the sender so that we may correct our records.
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