ICH guidelines provide guidelines for the world to be on one accord with human research. It provides a minimum standard that clinical research professionals should adhere to on an international level.International Air Transport Association (IATA) provides training on how to ship dangerous goods by air. There are blood, urine and biological samples (that have to be collected during subject study visits) and sent to the lab for testing in clinical trials. This task is most times completed by the study coordinator however it is good for the CRA to be aware of the process.
Commonly Used Clinical Research Terms
PI, SC, CRA, IRB, FDA, ICH/GCP, FD, IB, AE, SAE, ICF…What do all these acronyms mean??? In this lesson, we discuss most commonly used clinical research terms and their respective acronyms. In this course, you will learn about basic clinical research that will help you build a solid foundation in your clinical research journey!
As a CRA, you will have 3 main deliverables after any study visit. They are your confirmation letter, report and follow up letter. In this lesson, we will learn about the different sections of the monitoring visit report and practice writing a confirmation letter and follow up letter. Electronic Data Capture (EDC) systems house case report form (CRF) and collects patient clinical trial data documented on the source documents. In this lesson, we will discuss the importance of EDC systems and its role in clinical research.
How to Monitor Clinical Research Studies
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.
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