Facilitator: Michael Brennan
Working Group FocusAlthough three potential working groups were identified during the March 2012 meeting, the working group has decided to focus on one topic – gap analysis of the data standard. The overall goal of the gap analysis is to examine the data elements in the proposed dataset and assess whether the specific data element is addressed or handled by existing CDSIC data standards. It was agreed that the completion of the gap analysis was the primary deliverable for this working group. It was also agreed that it was not the charge of this working group to make recommendations for or propose new data standards. This is the appropriate remit of the CDISC organization.
Status of Work to Date Patty Gerend and Nate Freimark discussed the extent of analysis that has been done by the co-leads since March 2012. Patty Gerend presented a draft of site data model that grouped the requested data elements into specific domain. A sample data set has been made available to the working group.
Deliverables The group agreed that it would be able to complete the gap analysis by the end of 2012.
Meetings The group agreed that we would plan to meet biweekly (2nd and 4th Wednesday each month).
Roles We will need working group members to step forward and assume responsibility for the following roles:
- Wiki contributor – Responsible for updating the Wiki on a frequent basis, coordinating content with the working group co-leads and subgroups, and providing feedback to the Wiki administration group
- Group Communicator – Responsible for providing regular communications to the entire working group and managing the working group mailing list
- Steering Committee Liaison – Responsible for completing the monthly steering committee feedback form and providing outward communication of the working group activities when needed (e.g. PhUSE newsletter) – Michael Brennan to serve in this role.
- Meeting Facilitator – Responsible for setting up meeting, providing tools (call in number, web session), and posting meeting information/notes on the website
- Deliverable owner/co-owner – Owners should be identified for each deliverable identified by the working group who are responsible for providing updates and coordinating the team working on the deliverable. Patty Gerend,Nate Freimark and Jonathan Helfgott to serve in this role. It would be helpful to have one additional co-owner.
Please consider serving in one of these roles and provide your name to Michael Brennan (Mbrenna3@its.jnj.com)
Expanding the Functional Representation within the Working Group
Given the scope of the work, a point was made that we need to have representation from different functional areas such:
- Regulatory Affairs
- Clinical Operations
Working group members are asked to seek out additional representation from these functional areas within their companies. A request will also be made via the PhUSE newsletter and CDISC interchange meeting. We welcome any additional suggestions as to forums or groups to whom we should solicit participation.
Last revision by Mbrenna3,10/26/2012