CSS 2018 Breakout Session Discussions

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When: 4-6 March 2018
Place: Silver Spring
Facilitator: Jared Slain and Wendy Dobson
Scribe: Wendy Dobson

General discussion

Wendy presented draft slides for the CPE breakout session. These slides generated discussion, and Wendy added notes to the slides based on the discussion. The slides will be posted to Google Drive so that everyone can download and make additional edits/comments before CSS.

Do PhUSETube video on P-Values. Slides have been produced, need to find someone to present

Continue to look at educational videos on WhitePapers (Training on Safety Analytics)

Current FDA Internal Courses:-

  • FDA Clinical Trials
  • Statistical - Clinical Reviews
  • ICR
  • OCS Training on Data Standards
  • 3 courses on MEDRA
  • SDTM/ADaM
  • Tools - Review, Jump/Clinical

Action: To follow up with Alan Shairpo from FDA to see what courses can be shared

E-Learing Courses - to establish a repository and understand what exactly we want to create and how we integrate!

We need to put a process in place to understand what the communication plan is and how this will help the industry. Establish ways we can share this information

Targeting the right audience - Those involved in protocol writing and reviewing results is a good start

Discussion took place around re-structuring this Working Group. Should Code & White Papers be split?

There is a roundtable discussion taking place at JSM and Mercy maybe able to present on behalf of the Working Group

Continue to highlight conferences and submissions dates. Look to find whose attending and could present, even if outside of the Standard Analyses Working Group
We should be sharing what we have done to date and get feedback on this. Understand what is interesting, what isn't. Look to increase the concept of knowledge and find out what educational needs are missing. Understanding on how they want to receive the information i.e., videos, e-learning, t/confs, webinars. Highlight what we do that's different vs other industries.

Could we get links on the FDA website? for eg. FDA Resources for Data Standards - could PhUSE WhitePapers links be added here. Could a section within their website be added called additional useful information? Promote PhUSE more
Action: Speak with Helena

Clinical Review Template - could something be added here?
Action: Mary to speak with Nhi

PhUSE deliverables & Whitepapers are difficult to find in search engines. Needs to be more prominent

Wikipedia - this should be updated to include entries about PhUSE WhitePapers

Training on Safety Analytics would really be helpful, could educate the FDA



Last revision by WendyDobson,03/28/2018