Clinical research is a scientific intensive effort. A clinical research associate (CRA) is a clinical research personnel depicted by ICH GCP (Good clinical practice guidelines). ICH GCP uses the word Monitor in the place of CRA, the two terms are considered to be identical. The requirement for a Clinical research associate career is to have an UG or PG degree in life science, pharmacy or medical sciences. In infrequent cases, corporate will pick personnel with nursing degree with a registered certification.
Clinical Research Associate Education :-A clinical research associate (CRA) is a clinical trial personnel described by ICH GCP (Good clinical practice guidelines). As ICH GCP uses the term Monitor in the place of CRA, the two terms are well thought-out to be equal. The pre-requisite for a CRA job is to have an UG or PG qualification in pharma, life science, or health discipline. In rare cases, companies may choose candidates with nursing qualification with a registered nurse certification.
Clinical study, and Clinical trial both signify the same — a scientific endeavor to find out how a novel drug or treatment works in humans. Through clinical studies, medical practitioners find a novel and a better way to thwart, perceive, identify, manage, and treat ailments.
Role of clinical data manager :- Clinical trial is conducted to find out answers to the research queries by means of producing data to prove or disprove an assumption. Proper data management process will radically reduce time from drug development to commercialization. The clinical data management team ought to have sufficient process understanding that help in safeguarding the quality principles of CDM process.
The purpose of research is the enthusiasm to question an urgent issue or a situation & find answers to the question. The other facet of research is to publicise the work of a committee so that others will learn from what had been done to realize the specified results.
The good clinical practice (GCP) guidelines given by the department of Ayush addresses a long felt need for proper conduct of clinical trials on Ayurveda, Siddha and Unani (ASU) treatments and therapies.
What are the key tasks of a Clinical Research Associate in Clinical Trial experiments?
CRA Training :- A CRA (Clinical Research Associate) is responsible in design, scheduling, preparation, execution and review of a clinical trial experiment to guarantee it that it sticks to regulatory and ethical guidelines. CRA’s also play a key role in data exchange with all the stake holders.