Recorded December 2012
Imaging in Clinical Trials –
Unique Compliance Challenges
For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB are critical to protect human subjects and to demonstrate quality and integrity of the resulting data. When imaging is introduced into the trial, a new layer of complexity is added, and additional considerations with regard to helping sites maintain compliance with the imaging requirements should be implemented. Join us to learn how!
Here's what you'll learn from this recorded webinar:
The challenges that will occur when you introduce imaging in the trial, and how to manage:
- The increase in complexity of the protocols
- The addition of new stakeholders in the imaging process
- The addition of a new technology environment – storing, transmitting, and the unique challenge of image numbers and size
How to manage compliance challenges and invoke change dynamics:
- What non- compliance looks like
- The results of people not following the specifics of the protocols
- How to manage personnel and equipment changes during the trials
- Managing rogue reporting
Best Practices to make sure that you are in compliance:
- How to write protocols to stay in compliance
- Techniques for monitoring onsite compliance
- Approaches to take when you find you are out of compliance
Who should attend?
- Clinical Trial Managers
- Clinical Researchers
- Clinical Research Associates
- Clinical Affairs Managers
- Clinical Affairs Directors
- Scientific Directors
- Product Managers
- Regulatory Managers
- Anyone responsible for clinical trials or involved in setting up imaging protocols
- Anyone considering imaging in trials and could use support for internal stakeholders
Timothy J. Kulbago
Tim has over 14 years of experience in the medical imaging industry. He has held several executive positions including General Manager, Chief Technology Officer and Chief Strategy Officer. Most recently he was responsible for two businesses within Merge Healthcare (NASDAQ: MRGE). Tim was formerly the Chief Technology Officer of RIS Logic, a Solon Ohio based start-up company which created an industry-leading information system for radiology practices. Before joining the medical industry, Tim spent several years as a Research Assistant at the Applied Research Laboratory at The Pennsylvania State University, developing virtual reality training and visualization systems. Tim holds a Bachelor of Science degree from John Carroll University in Cleveland Ohio with studies in Computer Science, Physics and Math, and was honored with their “Distinguished Physics Alumnus Award” in 2004. He has a Master’s Degree in Acoustics from The Pennsylvania State University.
Under Sandra Maddock's leadership, IMARC Research was founded in 1999 to deliver the highest-quality clinical research monitoring, auditing, training/ development and consulting services.
Sandra offers IMARC partners 15-plus years of expertise covering: coronary and peripheral stents, angioplasty balloons, combination products, thrombolytics, chemotherapy agents, endovascular grafts for treatment of thoracic and abdominal aortic aneurysms, wound care, and dura mater replacement grafts. Whether serving as a global auditor for a device study across the U.S., Japan and Germany, or working with U.S. sites establishing GCP Compliance in preparation for an FDA Inspection, Sandra's hands-on approach has become her trademark.
Serving two years at North Ohio Heart Center provided Sandra with a solid start in research coordination. Her experience also includes nine years as a Registered Nurse on staff at EMH Regional Medical Center and Travel Nurse at locations throughout the country. She is a sought after speaker, active member of the National Association of Clinical Research Professionals and a founding member of the Northeastern Ohio Chapter of the Association of Clinical Research Professionals, where she has served as President, Membership Chair and Program Chair.
Sandra's credentials include RN, BSN, ACRP Certified Clinical Research Associate (CCRA). She received her Bachelor of Science degree in Nursing from Kent State University and is a qualified California Board of Registered Nursing Continuing Education Provider.