Strategies for Improving Site Selection

In this webinar, you will learn how  to optimize the site selection process and increase the likelihood of identifying and selecting study sites that will successfully conduct a specific clinical trial.

Processes commonly utilized will be examined for effectiveness and suggestions for improvement will be discussed.  Alternative processes which will be presented include conducting a protocol review to identify characteristics required by sites to successfully conduct a trial, developing a site profile from these characteristics, writing a customized Pre-trial Questionnaire from the site profile and communication skills needed to ascertain the Investigator’s true level of interest.

Common pitfalls of Pre-Trial Questionnaires currently used will be discussed. Results from a research study will be presented, with implications for improvement to make them a more effective tool in the site selection process. Data will be presented from the research study indicating which questions used on the Pre-Trial Questionnaire were most highly correlated with successful site performance.  Examples of how to change poorly worded questions to make them more useful will be included.  Tips for utilizing graphic design to make Pre-Trial Questionnaires more user-friendly will be explained.

Session Objectives

Upon completion of this session, participants should be able to:

• State which question on the Pre-Trial Questionnaire used during the research study discussed in this Webinar was most highly correlated with good site performance among sites selected to participate in the study
• Rewrite a question commonly included on Pre-Trial Questionnaires to make it more effective
• Define Lasagna’s Law and discuss strategies for minimizing its occurrence in sites selected to participate in a  clinical trial

Target Audience

Organizations and individuals involved in the site selection process, including sponsors, CROs, Site Recruitment Organizations and CRAs.

Organizations and individuals interested in being selected to participate in a clinical trial, including sites (Investigators, Study Coordinators), SMOs, AROs and TMOs.

Presenter

Sherry Reuter, BSN, MSHS has worked in the pharmaceutical industry for more than 14 years. As a result of her work in diverse settings in the industry, including large pharmaceutical companies, small biotech companies, major CROs, Academia and as an Independent Consultant, she has a unique perspective of how the stakeholders in the industry work and interact. Ms. Reuter holds a Bachelor of Science in Nursing from Emory University and practiced Nursing in a variety of specialties and leadership positions. She earned her Masters Degree in Clinical Research from The George Washington University, was appointed to the faculty, and serves as an Adjunct Professor teaching assorted topics in clinical research.  Ms. Reuter has spoken on diverse topics at industry meetings and has published articles in a number of industry journals.

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 CBRN-11147-2008-AUD-350). Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-000-08-014-C04P has been assigned to this program. This program provides 1.5 contact hours of continuing education credit. Each participant must complete an online evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 8/6/08. 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-2008-AUD-349).

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.