SS P08 14Aug2014 Standard Scripts Project 08 Meeting

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Meeting Record

When: 14 August 2014
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Rebeka, Simin, Terry, Hanming, Mercy, Wei, Sheryl

  1. AE White Paper discussion


Discussion on whether Related SAEs and Related Disc AEs should be added to overview. This would be added to overview only if we decide to add these tables. Proposal on the table is that we don't have these. We can see if we get review comments on this.

Discussed total column - decided we don't need them for these tables. Likely applies to our other white papers, except there are some that we probably want a total column (e.g., demographics).

Discussed number of events. Proposal on the table is that we don't have this for the run-of-the-mill adverse event. (Understood that this might be needed for special topics, but that would be out-of-scope.) We can see if we get review comments on this. We might need if required by CT Registry or Japan - requires follow-up.

Disussed AE ordering. SOC would be alphabetical and PTs within SOC would be in decreasing frequency order. (Sheryl to make footnote clear.)

Discussed SAEs. We have been assuming this is based on regulatory-defined serious. We need to state (in text) that we are making this assumption - If a company assigns other events as SAE beyond regulatory-defined, then the sponsor will need to decide whether to have a single SAE summary (with all of theri SAEs) or create a separate summary of just those that meet regulatory-defined serious and another that has all of their SAEs. (Mary and Sheryl to propose text.)

CTCAE - We decided we want each individual category and the cumulative categories (>=2, >=3, >=4). (Mary and Sheryl to draft updated table.)

  • Last revision by Jmbodart,10/13/2015