Clinical Research is witnessing a tremendous progress in the last couple of years. Despite the fact that many sees it as a relatively new discipline with relatively new developments, the idea behind carrying out trials with medical purposes is pretty much ancient. Thus, the very first officially known clinical study was performed by the Scottish physician James Lind back in 1747. His systematic research had the goal to prevent maritime diseases and find cure for scurvy – a disease now known to be the result of a Vitamin C deficiency. Interestingly enough, it was just after 1750 when the field began to adopt earlier modern shapes of what we see now. However, no matter how long the evolution path of clinical trials has been or what changes in terms of trends, tools, mechanisms and skills have been experienced, there is one thing for sure. Every Clinical Trial project should ensure quality, efficacy and safety. These are the three main purposes when testing treatments involving drugs: developing quality products; determining and learning if such treatments work effectively and, lastly, guaranteeing whether they are safe or they pose too many risks on patients. In this regard, in order to perform a successful trial which delivers the three aspects mentioned above, there is a need of crystal clear objectives, easy-to-follow design, pre-defined methodologies, appropriate tools, well-suited facility, trained personnel and more. To make sure that everyone involved in the study understand the specifics of the trial, such as measurements, tasks, purpose, procedures to be carried out and so on, investigators should develop a clinical trial protocol.
In essence, the preparation of a protocol requires the mutual effort of experts in traditional medicine, physicians, pharmacists, clinical pharmacologists and other healthcare workers involved in the process. The overall protocol group though is led by the chief investigator who is also a physician. Preparing one such document, however, can be a lengthy process that asks for additional knowledge and understanding. From setting up a timeline and schedules, to assigning responsibilities, the content of a clinical trial protocol must be developed with extreme care and proficiency. Otherwise, it may affect the quality and results of the whole study.
Realizing how important one such document turns out to be, we at Astra Nova prepared a free training on how to prepare a Clinical Trial Protocol in the most efficient way. Our course explains what clinical protocols represent and how physicians should follow them in order to provide clearness, excellence, integrity, quality and safety. We have also specified how modifications to the protocol are made and when they should be made. There is also a list of what exactly the document should include in order to facilitate the work of the personnel and guarantee the successful implementation and completion of the study itself.
BUT WHO CAN BENEFIT OF ONE SUCH COURSE?
The Clinical Trial Protocols training will be useful to:
- Clinical Trial Managers
- CRAs
- Quality Assurance Managers
- Quality Control Managers
- Clinical Research Staff
- Auditors
- Students
- Clinical Research Trainees
More information about the course is available in the link bellow.
https://crotraining.co.uk/free-training/clinical-trial-protocols/
However, if you want to learn how to apply the regulations reviewed in our free Clinical Trials Protocols training and receive an international GCP certification, you can sign up for the FULL GCP online course here. There is also Good Clinical Practice course UK edition and Good Clinical Practice course US edition both adapted for local regulations, laws and requirements.
You can find a PDF version of this article here: https://crotraining.co.uk/wp-content/uploads/2016/09/CHOOSING-A-COURSE-ON-CLINICAL-TRIAL-PROTOCOLS.pdf
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