Imaging in Clinical Trials: Maximizing Protocol Compliance & Image Standardization

Program Description

Clinical trials frequently include medical imaging studies (i.e. x-rays, PET scans, CT scans) as part of the efficacy evaluation of an investigational drug. Unless a study coordinator has a background in medical imaging, it can be difficult to understand what data to request and in what format it is available. The purpose of this webinar presentation is to describe clinical trials from a medical imaging point of view, and alert study coordinators to potential pitfalls in collecting image data. Armed with basic information about radiology studies, study coordinators can maximize protocol compliance and increase subject evaluability.

Anonymization methods for digital data and archiving methods used in imaging departments will be covered in this webinar. The speaker will provide basic information about x-ray, PET, CT, and cardiac imaging. PACs (Picture archiving systems) and RIS (radiology information systems) and how they store clinical trial data will be discussed.

Imaging core labs are often used by sponsors to gather digital data and provide initial evaluation of radiology studies. This presentation will provide suggestions about how to communicate effectively with imaging core labs, and what data is expected of a clinical trial site.

Study coordinators and research nurses who have familiarity with medical imaging techniques and data storage methods will be able to maximize protocol compliance at their site. Monitors who are informed about medical imaging techniques and the common terms used radiology will be better able to facilitate accurate data collection.

The learning objectives will be met by providing the attendees with a handout of the slides, and a glossary of commonly used terms in medical imaging.

We will also use audience interactive polling questions throughout the presentation to determine whether the attendees have gained new knowledge.

Target Audience

This activity is intended for Study Coordinators, Research Nurses, Investigators, and Monitors.

Learning Objectives

Upon completion of this webinar, attendees should be able to:

• Define commonly used terms in radiology that are related to clinical trials
• Describe the process for obtaining digital and hard-copy data from medical imaging procedures in clinical trials
• Communicate more effectively with medical imaging departments about clinical trial protocol requirements

Presenter

LisaAnn Trembath, MSM, CCRA is the Manager of Medical Affairs and Clinical Trials Manager for Cellectar, Inc. She has had over 15 years of experience with sponsored clinical trials in various roles in both the academic medical center setting and pharmaceutical industry, including as a research technologist, study coordinator, clinical research monitor, and project manager. Ms. Trembath is a Certified Nuclear Medicine Technologist, and a certified Nuclear Cardiology Technologist. Ms. Trembath graduated with a Masters Degree in Business Management from Cardinal Stritch University after completing her thesis comparing methods of compliance training in the banking, insurance, and pharmaceutical industry.

Ms. Trembath states that she will be discussing the off-label use of a drug, F-18 FLT. She has no actual or potential financial conflict of interest in relation to this program.

Accreditation Information

Continuing Nursing Education

The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2010-310).

Accreditation Council for Continuing Medical Education

The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Association of Clinical Research Professionals designates this educational activity for a maximum of 1.5 AMA PRA Category 1 credits™.   Each physician should only claim credit commensurate with the extent of their participation in the activity (Program Number 0007229-2010-CME-310).

Association of Clinical Research Professionals

The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form.  These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2010-WEB-310).

Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.