How to Monitor Clinical Research Studies

How to Monitor Clinical Research Studies

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In this course, we will start discussing the CRA role, monitoring skills and expectations. You will begin to understand the basics of the role. See where you can improve.  Is it medical terminology? Do you need to take a medical terminology course? Therapeutic are knowledge? Education? Presentation skills? Communicating effectively? Speaking with physicians? Writing skills? Let’s get into the 4 types of visits you will be conducting as a CRA – PSSV, SIV, IMV and COV (EDC, EMR, eSource, ConMed, AE Logs, SDV/SDR, IP accountability, Investigator Site File.

How is clinical research data documented? What are the documentation standards? We will discuss both topics in this section. In a nutshell, source documents are created (most times by the research site) before the study begins at the site. How they are created is determined by ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate).  I will show you some examples so you can SEE how ALCOA works!

In this lesson, you will see which regulatory documents are essential regulatory documents. The essential regulatory documents are required by the Sponsor/Food and Drug Administration before a clinical trial can begin at an investigative site. Once a study has started at a site, the site must avoid protocol deviations as much as possible. What is protocol deviation? 

The investigational product (IP) is the test article of any pharmaceutical clinical trial. It is also a product that is in its investigative site and NOT approved by the FDA. Because of this the IP data is constantly updated in the Investigators Brochure as studies are conducted. Also, IP dispensation is tracked on log by the site and subject.