SEND Implementation Minutes 2012-05-04

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Present: Jen, Sue, Troy, Lynda, Lou Ann, Bill

Discussion:

1. Intercompany Data Exchange
a. Troy helped Sue get started with Wiki. Early next week Sue plans to create a description of Intercompany Data Exchange modeled after the other groups under working group 6.
b. Shree and Bill have started drafting data flow template and plan to have a draft with two examples available for comment. In today’s discussion we explored the idea that we will have
i. Use cases scenarios (like the following:)
1. CRO provides full SEND dataset
2. A specialty component of a study is performed by a CRO that has no SEND capability
ii. Perturbations that affect the scenario (e.g.:)
1. Amendments to the protocol
2. Audits that trigger data changes
3. Changes to the latest version of Controlled Terminology
4. Changes to the latest version of SEND IG
iii. Concerns (e.g.:)
1. GLP compliance
2. Supplying CAS #
c. Perhaps we should select a couple scenarios to think through the impacts of perturbations and determine solutions.
d. Bill will schedule a discussion with Shree and Sue to explore these ideas with Shree.
2. SEND User Group
a. Troy and Lynda are waiting to process responses to call for participation.
b. Troy pointed out that the structure of WG6 is odd in that there are two groups in the SEND implementation group that have not particular need to be under s separate governance committee. Everyone present appeared to be in favor of flattening this structure. Troy sent an email to Tim to propose the idea.
3. Next Meeting in 2 weeks at the same time (May 18, 2012 at 1:00 EDT)