Event Calendar

Site Management

Download Breakout Session Overviews  | Download Schedule of Breakout Sessions   | View Preconference Workshops   | View Conference Schedule

2019 Agenda


 

Friday, September 27, 1:15-2:00                                     

Unpacking the FDA Clinical Investigator Inspection Process in order to Maximize the Probability of Successful Inspection Outcomes

Conducting clinical research in an FDA inspection-ready environment is crucial and is arguably the best predictor for a positive FDA inspection outcome. As such, understanding the FDA inspection process should motivate an investigator’s clinical research-related processes. Lastly, navigating the FDA inspection process from inception to complete resolution often relies on a savvy understanding of how to best respond whenever 483-worthy findings are noted. 309

Presenter: T. Che Jarrell, BSPH, MPIA, RAC, Proprietor & Principal Consultant, Milestone Regulatory Experts, LLC 

 

T. Che Jarrell, BSPH, MPIA, RAC, 
Proprietor & Principal Consultant, Milestone Regulatory Experts, LLC

Track: Site Management


 

Friday, September 27, 2:05-2:50                                      

Source Documentation: Common Pitfalls and Site Monitoring Visit Findings

Source documentation issues is one of the most common findings cited by clinical site monitors. The source document should speak to the patient’s progression in the trial and how the data is initially obtained. Missing or inadequate source documentation jeopardizes the patient’s safety and eligibility, and the accuracy and reliability of the data. To avoid common pitfalls and cited monitoring findings, source documentation should be clearly defined and agreed upon by the site PI, research staff, and sponsor/CRO prior to trial initiation. 311

Presenter: Taylor Swankie, Public Health Analyst/Clinical Research Coordinator, RTI International

Track: Site Management


Friday, September 27, 3:25-4:10                                       

How to Use Excel to Coordinate Your Studies

Learn to use the features in Excel to coordinate studies and patients. Use Excel to manage complicated studies, track patient visits and required observations. Use date fill features, conditional formatting, worksheets, and formulas. 313

Presenter: Amy Rowell, MS, CCRP, Director of Oncology Clinical Trials, University of Texas Medical Branch

Track: Site Management


Friday, September 27, 4:15-5:00                                   

Private Practice Research Culture and Compliance Transformation

Ms. Iovanni will focus on research culture transformation efforts at a community, non-academic, private, medical practice, with a for profit partner. Challenges, successes and strategies that are easily transferrable to a variety of research site types, will also be discussed. 315

Presenter:  Linda Iovanni, MBA, BSN, RN, COO, Research Director, Maryland Oncology

Track: Site Management