SEND Implementation Minutes 2012-06-01

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Present: Troy, Peggy, Jen, Kathy, Shree, Bill

Discussion:

1. Interorganizational SEND Wiki - Bill shared the current version with the team and encouraged everyone to review it and adjust it.
2. Use Case Scenarios
a. We spent a little time discussing the SIPOC developed on May 18 and decided to add a column on the left for the Process Owner. Some felt that this might be at a little too high of a level and not capture the detail where challenges happen.
b. We discussed the possibility of creating RACI charts. Some felt this was too detailed.
c. Some suggested crating process maps.
d. We decided to generate a list of scenarios based on combinations of the following dimensions. Troy to create a list
i. Location of Study Director (Sponsor, CRO)
ii. SEND compiler / final editor (Sponsor, CRO)
iii. Information Source (All CRO; All Sponsor; Some CRO, Some Sponsor; All CRO with some from subcontractor; All Sponsor with some from subcontractor; Some CRO, Some contractor, Some Subcontractor)
iv. Each organization involved (Sponsor, CRO, Sub-contractor) has these attributes:
1. SEND Capability (None, Some, All)
2. SEND Data Flow Direction (Receiver Only, Producer Only, Receiver and Producer)
3. Some general questions came up
a. Which organization is responsible for SEND dataset for a multi-site study, should it be the Study Director’s organization or not necessarily?
- Shree to check if this is in-scope for another PhUSE track.
b. Can CAS number be supplied by other means so datasets can be finalized at study completion?
- Shree to ask Tim about this possibility.
4. Next Meeting in 2 weeks at the same time (June 15, 2012 at 1:00 EDT)
Draft Agenda
- Review action items from last meeting.
- Review the status of the general questions from last meeting and next steps for resolution
- Are there other general questions we should consider?
- Select up to 3 scenarios as top priorities
- Determine if we should use sub-groups to create detailed scenario descriptions or do in these meetings