Data Standards Monthly Project Lead 19 August 2019 Meeting Minutes
- Project team updates
- Aatiya Zaidi
- Aimee Basile
- Amy Palmer
- Bess LeRoy
- Jane Lozano
- Kiran Kundarapu
- Mike Hamidi
- Satheesh Avvaru
- Vincent Guo
- Vladlen Ivanushkin
- Wendy Dobson
|Best Practices for Data Collection Instructions||Todd Bazin and Aimee Basile||Kick-off meeting occurred. Discussed frequency of meetings (Wendy sent a doodle). Going to keep original scope and concentrate on the treatment emergent white paper first. Possibly going to do a survey instead of interviews about AE process information and drill down.|
|CDISC Implementation Primer||Beate Hientzsch, Yvonne Moore, Bess LeRoy||Team is dropping one of the topics (CDISC compliance) due to bandwidth. At the CDISC Interchange in October the team will show a demo. Three minute videos with captivate content with an overview of each foundational standard. Traceability sub-team didn't receive any comments from public review but recently received comments from CDISC. Traceability is a powerpoint with a narrated script. Per Wendy, it will be put on the PhUSE site as a deliverable and can be linked to the CDISC site.|
|Data Reviewer's Guide in XML||Mike Hamidi||Team has made significant amount of progress since prototype loaded to PhUSE website. Did a presentation to the non-clinical team. Need to upload package to the PhUSE website for the FR notice (approximately September). Waiting on agreement from FDA with the plan.|
|Data Standards for Non-Interventional Studies||Yuliia Bahatska and Vladlen Ivanushkin||Continuing to work on draft of the white paper. Team will be discussing the rules that are applicable/not applicable to these studies.|
|Industry Experiences Submitting Standardised Study Data to Regulatory Authorities||Todd Case and Vincent Guo||Presentation at PhUSE Single Day Event in September (Pennsylvania). Todd will attend. Draft white paper should be available for review by Jane/Lisa and steering committee in October.|
|Integrated SDTM and ADaM Reviewers Guide||Kiran Kundarapu and Satheesh Avvaru||Kick-off the week of 9 September. Wendy has sent a doodle to determine when most people can attend. Presenting at September Webinar. Jane to follow up with Matilde to discuss the project.|
|SDTM ADaM Implementation FAQ||Bhavin Busa, Amy Palmer, and Aatiya Zaidi||Ongoing project. Adjudication white paper - waiting for final deliverable from Umed and a summary of changes. Paper will go back to Jane/Lisa and then the steering committee to determine if another round of public review is necessary.
Wendy still wants to meet with the project co-leads to discuss process improvements. Unable to find a good time to meet due to summer holidays. ISS/ISE Best Practices white paper changing name (Integration Strategies in Support of ISS/ISE Submissions) and ready for steering committee in a couple of weeks.
- Register now for EU Connect (November 9-12). Registration still open.
- US Connect 2020 (March in Florida). Deadline to submit abstract is 13 September.
- Wendy to have a 1:1 with Dave Epstein tomorrow. If you have anything that you would like Wendy to discuss with Dave please let her know.
- The PhUSE site is being reorganized in regards to deliverables, including white papers. Timeline is early to mid-September. There will be a new gray bar at the top for Working Groups Deliverables which will be divided into three sections (Regulatory Referenced Deliverables, Deliverables Under Review, and White Papers).
- [Jane] Follow up with Matilde.