Investigator Meetings
September 18, 2019, Ann Arbor, MI
Introduction and Primary Analysis Results
PK/PD
Slides (Abhishek Sathe) Slides (Lisa Coles)
EFIC Activities
Slides (Neil Dickert) Slides (Deneil Harney)
Close-Out Activities
Finance Overview
Survey/Discussion PAD Experience
Secondary Publications
Next SE Treatment Trial Ideas
March 6, 2018, Scottsdale, AZ
Study Updates – Kapur
Site and Regulatory Updates – Bengelink
PK/PD Study Refresher – Coles
Innovations and Brainstorming – Peer to Peer
Publications – Chamberlain
Next SE Treatment Trial Ideas – Kapur
Emergency EEG Demo Ceribell – Parvizi
Protocol Refresher and SAE Reporting – Silbergleit
Protocol Assist Device – Harris
WebDCU Refresher – Riley and Alford
Introductions – Kapur
Enrollment and Site Updates – Bengelink
Supporting Best Practices – Kapur, Chamberlain and Silbergleit
Site Monitoring – Harsh and Speers
WebDCU Reminders and Practice – Conner and Riley
Training Practices, Innovations and Brainstorming:
Simulator Training
Screening Tips
Securing Remote Monitoring Privileges
Protocol Assist Device Training and Maintenence
Protocol Assist Device Update and Tutorial
Financial, Regulatory and Administrative Reminders – Stevenson, Gray and Bengelink
Slides – Financial
Slides – Regulatory
Publications Workshop – Shinnar, Chamberlain and Kapur
Protocol Review and Refresher – Silbergleit
PK/PD Ancillary Protocol – Coles
Thursday, September 17th:
Welcome and Opening Remarks – Kapur
ESETT Overview – ESETT PIs and Core Leadership
Friday, September 18th:
Protocol Training
Eligibility & Enrollment – Chamberlain
Outcomes – Silbergleit
Enrollment Video
Protocol-Specific Topics
Pharmacy and Study Drug Procedures, WebDCU Drug Tracking – Cloyd/Conner
Use Next Boxes – Bengelink
Protocol Assist Device – Fansler
Adverse Event Reporting – Dillon/Silbergleit
Start-up and Regulatory Consideration
EFIC – Harney
Regulatory Documents, Site Readiness and Start-up – Bengelink/Ramkrishnan
Contracts and Payment – Gray/Stevenson
Overview of EEG Study – Betjemann/Litt
Overview of Pharmacokintic Study – Coles