Investigator Meetings

Initiation for New Hubs November 12, 2012 - Atlanta, GA

Initiation Meeting January 9-11, 2012 - Atlanta, GA

 

 

 

Initiation for New Hubs November 12, 2012 - Atlanta, GA
November 12th
Opening Remarks: Bill Barsan, MD / Scott Janis, PhD / Karen Johnston, MD

Video (8:09)

 

 

Eligibility: Karen Johnston, MD
Slides

Video (16:14)

 

 

 

Protocol Training 

Slides  

Video (1:17:23)

 

  • Review of the Basics: Askiel Bruno, MD
  • Hypoglycemia Protocols and Pauses: Askiel Bruno, MD
  • Post Protocol and Outcomes: Karen Johnston, MD

 

Monitoring: Donna Harsh, MS / Shirley Frederiksen, MS, RN

Slides

Video (21:20)

 

 

 

Study Laptop Training: Denise Zito

Slides

Video (1:00:58)

 

 

 

Protocol Cases and Q&A: Karen Johnston, Md

Slides

Video (25:45)

 

 

 

Recruitment Update: Chris Hall, MD

Slides

Video (11:24)

 

 

 

Randomization and Navigating in WebDCU: Karen Briggs

Slides

Video (26:12)
 

 

Preparing for Site Readiness

  • Preparing Study Orders and Laptops: Amy Fansler

Slides

Video (9:33)
 

 

  • Regulatory Requirements and Readiness Call Process: Arthi Ramakrishnan  

Slides

Video (17:07)
 

 

  • Coordinator Panel from Enrolling Sites: Irene Ewing / Amy Fansler / Alex Hall / Hannah Reimer

Video (35:25)
 

 

Safety Reporting: Catherine Dillon

Slides

Video (21:08)
 

 

I-SPOT: Nina Gentile, MD / Hannah Reimer

Slides

Video (23:00)
 

 

 

Initiation Meeting January 9-11, 2012 - Atlanta, GA
January 9th
Welcome and Opening Remarks

http://nett.sites.uofmhosting.net/node/211/edit
Trial Overview (35:15): Karen Johnston, MD

Slides

January 10th
Protocol Training 

Eligibility and Enrollment, Randomization (53:22): Karen Johnston, MD

Slides


Overview of Treatment Groups (45:26): Askiel Bruno, MD

Slides


Treatment Protocols (24:42): Askiel Bruno, MD

Slides


Outcomes (15:15): Karen Johnston, MD

Slides


I-SPOT Ancillary Trial (4:12): Nina Gentile, MD

Slides

Protocol Special Topics

Beds (15:51): Christiana Hall, MD

Slides


Pharmacy and Blinding (17:29): Amy Fansler

Slides


Role of the Lead Nurse (28:16): Claudette Lohr

Slides

Study Laptop Overview (57:57): Denise Zito

Slides

GlucoStabilizer and Control Treatment Screen Training & Simulations (1:49:20): Denise Zito

Questions & Answers (3:41): Karen Johnston, MD

January 11th
Start Up Procedures

Study Timeline and Recruitment (29:12): Christiana Hall, MD

Slides


Training and Regulatory Requirements (10:55): Allison Kade

Slides

Data Management/WebDCU

Training and Randomization; Database/Presentation on WebDCU (44:15): Catherine Dillon

 

Safety and Monitoring

Adverse Events (18:27): Catherine Dillon

Slides


Site Monitoring Plan (16:59): Shirley Frederiksen and Donna Harsh

Slides

Contracts and Invoicing (9:13): Valerie Stevenson

Slides

Questions and Answers/Closing Remarks (8:00): Karen Johnston, MD

Slides