SS P08 18Sept2014 Standard Scripts Project 08 Meeting
When: 18 September 2014
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Mercy, Kim, Nancy, Terry, Mohammad, Sheryl, Frank
- PhUSE Annual Meeting
- Status of each white paper
Discussed upcoming PhUSE annual meeting - We do have a poster (Ann Croft and Dirk Spruck covering) for the White Papers project, with associated paper. Our Working Group will also have an approximatly 15 minute presentation during one of the sessions (Chris Decker hosting, Mike Carniello covering for our WG). Mary showed draft poster to the group.
Status of each white paper:
- Outliers/shifts - Close to sending for broad review. (Mary to send to Steering Committee.)
- AEs - Close to sending for broad review. (In Mary's hands to send to Steering Committee.)
- Demo/Disp/Med - Close to making final. In Mary's hands to send to Steering Committee. However, pausing a little to wait for FDA feedback. Mat indicated it was being reviewed within the FDA.
- Hepatotoxicity - Terry should have a draft ready for the White Papers Project team to review by end of the month.
- QT Studes - In progress.
- Kim asked about the FDA Reporting Rule and whether it's impacting clinical trial data collection (e.g., marking AEs as disease-related). It was noted that there is a lot of variation on how desease-related events are collected irrespective of the FDA Reporting Rule. In theory, the rule should not impact CT collection. Mary to get Kim and Brenda together.
- Mary asked about the planned/unplanned paragraph in the first final white paper. How is that implemented? It appears everyone collects visit and distinguishes between planned and unplanned in collected data, and that is brought into SDTM. How well that is cleaned varies. It appears some companies implement "visit windowing" in ADaM. When visit windowing is done, could be related to how well visits are cleaned. It seems there is some push and pull. Cleaning people wonder why they clean visit if visit windowing is done in ADaM. The ADaM people incorporate visit windowing when they can't trust the visits. It appears that we all agree that using the planned visit from SDTM (and presumable moved forward to ADaM) is preferred over using a derived visit.
- Nancy asked whether questionairre data is in scope for the White Papers Project team. (ADaM group is working on Questionairre data and is difficult without having shells.) Conceptually, these can be in scope, especially those that span across therapeutic areas. If TA-specific, perhaps that should go TransCelerate. Mary is hoping to organize a PhUSE/ADaM/TransCelerate meeting the day after the CSS Symposium in March. The idea is to figure out the scope of each group. Mary thinks PhUSE can take areas that span across TAs, TransCelerate can take TA-specific things but should include TFL shells.
- Last revision by Jmbodart,10/13/2015