This virtual session will take place on Saturday, December 4, 2021 and aims to:

  1. Enhance faculty and fellow understanding of key Hopkins players and available research resources (including study planning support and data collection tools)
  2. Discuss study planning and initiation (budget, contracts, IRB, research team), responsibilities of the Principle Investigator, and study start-up activities
  3. Detail elements of conducting a clinical trial
  4. Discuss challenges and solutions for establishing a successful clinical trials unit

Attendees: Gastroenterology and Hepatology clinical and research fellows, faculty, research staff

To register, click here.

AM Session – Initiating Your Clinical Trial

8:00-8:10 Welcome, course overview, goals of the meeting Mimi Canto
PLANNING YOUR CLINICAL TRIAL – Design, Research Team, Collaborations with Industry Moderator: Mimi Canto
8:10-8:40 Clinical trial designs and sample size considerations– the basics Prasad Iyer (Mayo)
8:40-9:00 Building your research team -feasibility assessment, workflow development, staffing for clinical trials coordinator/staff oversight, hiring, management and delegation Susan Moist (UNC)
9:00-9:20 PI responsibilities, multicenter trials, registries, sponsor and CRO interaction Nicholas Shaheen
9:20-9:40 Collaboration with industry, how to determine if the budget is feasible, common pitfalls and examples of successful/failed clinical trials – what should I know before initiating industry-sponsored clinical trials Mark Sulkowski

 

9:40-10:00 Q & A, panel discussion Iyer, Moist, Shaheen, Sulkowski
10:00-10:10 Break
PLANNING YOUR CLINICAL TRIAL – Budget, Contract, Regulatory, IRB Moderator: Ellie Afghani
10:10-10:40 Budget preparation - understanding billing coverage analysis, compliance Karen Roz (Director ORA, clinical research)
10:40-11:00 IRB application review types
Considerations for research participants
Ethical considerations
Megan Singleton, JD, MBE, CIP
Associate Dean, Human Research Protections and Director of the Human Research Protections Program
11:00-11:20 Contract review and execution
JHU contract offices and process overview
Regulatory considerations for drug and device trials IND, IDE
Research consulting and other opportunities for compliant interaction with industry
Mont Brownlee (Senior Director, ORA)
11:20-12:00 Sample clinical trials for design, budget, staffing, contracting, Q & A, panel discussion Elham Afhani, Venkat Akshintala, Megan Singleton, Karen Roz, Mont Brownlee
12:00-12:20 Lunch break

PM Session – Conducting Your Clinical Trial and Publishing Your Results

COMPLIANCE ISSUES, DATA COLLECTION, AND DATA MANAGEMENT Moderators: Ken Hui/Aly Strauss
12:20-12:50 Adverse events and protocol deviations

Assessments, documentation, and reporting to regulatory bodies and sponsors; examples

Fred Luthardt, Jr., Suzanna Roettger (Office of Human Subjects Research)

Megan Singleton, Associate Dean, Human Research Protections

12:50-1:10 Conflict of interest in clinical trials Ashley Carpenter (Office of Policy and Coordination)
1:10- 1:30 BEAD Jacky Jennings (Director, BEAD)
1:30:150 ICTR Dan Ford (Director, ICTR)
1:50-2:20 REDCap and REDCAP-EPIC connector Scott Carey (Director, REDCap)
2:20-2:40 Informatics services for research data collection, extraction and storage: Epic and Precision Medicine Analytic Platform (PMAP) Bonnie Woods (Director IT, ICTR)
2:40-3:00 Q & A, panel discussion Suzanna Roettger, Fred Luthardt, Ashley Carpenter, Jacky Jennings, Dan Ford, Scott Carey, Bonnie Woods, Ken Hui, Aly Strauss
3:00-3:10 Break
DATA ANALYSIS, MANUSCRIPT PREPARATION, AUTHORSHIP Moderator: Venkat Akshintala
3:10-3:30 Data analysis, thinking about your manuscript and where to submit Nicholas Shaheen
3:30-3:50 Authorship Stephen Meltzer
3:50-4:10 Q & A Nick Shaheen, Steve Meltzer, Venkat Akshintala
RESEARCH CHALLENGES, CASE DISCUSSIONS, BUILDING A SUCCESSFUL CTU Moderator: Mimi Canto
4:10-4:25 Specific study challenges (pre-submit), feedback on specific research challenges  – case discussions Mimi, Nick, Susie
4:25-4:45 The UNC Clinical Trials Unit – how to build a successful CTU Nick and Susie
4:45-4:55 Q & A Mimi, Nick, Susie
4:55-5:00 Closing remarks, Adjourn Mimi
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