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Competent study coordinators improve efficiency, reduce business and regulatory risk, and support marketing programs. Study sponsors want to know they can rely on sites for high-quality work. The Site Council has, therefore, collaborated with CRA Assessments on an objective study of CRC competency. A realistic “in-box” simulation exercise (not an exam) has revealed dramatic variations in competency. Alarmingly, the average score on five basic competencies was 45%. Study coordinators with 10 or more years of experience scored 30% to 78%.
CRA Assessments has assessed the competency of 8,500 site monitors and found somewhat better results: an average score of 51%. The good news is that training increased the average score to 68%.
When the product officially launches in August, CRA Assessments will charge $600 per person. The price for Site Council members will be only $400. Better yet, the Site Council member price for the first 100 study coordinators will be only $300.To learn more, contact Gerald DeWolfe, founder and CEO of CRA Assessments, at gerald.dewolfe@craassessments.com. Tell him you are a Site Council member.To read more about the study, click here.To read a previous survey about study coordinator work quality, click here. This simulation product is the first new idea in a long time for improving study coordinator competency, so let's get behind it.
Quality Management Systems. Study sponsors typically spend 20% or more of a study budget on site monitoring. Despite that huge cost, even experienced site monitors typically find only about half of the important issues. There must be a better way...and there is: A mature quality management system (QMS) at the site can build quality in rather than relying on site monitors to inspect errors out. The FDA has been promoting risk-based site monitoring for a decade, and this is the logical next step. To learn more, click here.
Study Coordinator Work Quality. High quality study coordinator work is at the very heart of clinical research. What are the driving forces? To find out, click here.
Site Council members receive a free weekly email with six fresh study opportunities, courtesy of ClinWire.
12 Questions we need to answer to achieve diversity in clinical research
We can minimize duplicative efforts and accelerate learning through collaboration. The best place to start this collaboration is to develop consensus answers to 12 fundamental questions. To start with, how do we define "diversity"? To view an article in ACT Magazine that discusses these questions, click here.
What does diversity in a clinical trial actually mean?
A recent article in ACT Magazine includes a spreadsheet you can use to define, prioritize, calculate and communicate a quantitative diversity score for your clinical study. Now we can know exactly what diversity means. To view the article, "Calculating Diversity in Clinical Research Studies," click here.
For a free download of the clinical study diversity calculator, please enter the following information:
Free-for-all competitive enrollment may be fast, but it can create chaos. Managed competitive enrollment avoids chaos, is more predictable, is no slower, and may deliver superior quality. To view an article on managed competitive enrollment, click here.
Has a study sponsor ever notified its sites that obsolete study records may be destroyed? Apparently not, and that’s why study sites are storing countless boxes of obsolete study records. What a pointless waste. To view an article that addresses this problem, click here. To view additional material, click here.
To download a Site Council flyer, click here.
