May 31, 2016 Minutes

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May 31 Data Visualizations

Attendees: Teresa Ancukiewicz, Mary Banach, Michael Colopy, Eric Herbel, Johan Proeve, Lorne Cheesman, Dale Plummer, Rebeka Revis, Mike Rubison, Sanjay Matange, Paul Schuette, Stanley Wei, Xiangyum Wang

Mike: Discussing the four groups – Do we need any other groups?

Group 3 Discussion:

Sanjay: Right now we are calling it interactive vs static, but it really is not an either or. On static graphs, we may need with drill down abilities or interactive graphs.

Rebeka: Looking at safety graphics with interactive and static graphs.

Group 4 Discussion:

Johan: Who are the people involved in RBM e.g. site monitors, remote monitors, clinical data management, medical monitors. What do we expect them to do on our teams? Where do they belong? Remote monitor are a new category. How do the remote monitors, clinical data managers, medical monitors cooperate?

Lorne: Looking at a different approach to RBM with data dashboard and function analysis of risk.

Mike: We will capture the ideas, priorities making a good start for this year with a good sense of direction.

Lorne: A white paper would be appropriate, where we can ask questions. We can develop checklists from the white paper.

Teresa: We are not just talking about traditional roles. We need checklists and guidance.

Johan: We are looking at helping customers. DIA is just the vehicle. The white paper or checklist must have ACTUAL EXAMPLES.

Teresa: The actual examples need best practices. We have noticed that many of RBM vendors produce such documents.

Group 2 Discussion

Lisa: On the Group 2 deliverables what does it mean to have site performance? Are we talking about safety events occurring more frequently? Are we looking across sites; in geographical areas; training issues involved? As stat reviewers we look at outcomes by site and ask if there is something unusual about that site.

Mike: We are going to focus on performance matrix, focus on sites. management and monitoring issues. Lisa: AZ has an initiative with a governance committee. You can review the materials and identify the information.

Next meeting: June 14, 2016

Check Deliverable 2 for datasets from Lisa, Deliverable 3 for suggestions from Sanjay, and Deliverable 4 for suggestions from Johan and Teresa.