2013年10月8日星期二
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Classes http://www.babeloo.co.uk/blog/ and
certification Eric garrison http://www.babeloo.co.uk/ A clinical
trial is concerned with the scientific study of risks and effects of a medicinal
product, testing at http://www.babeloo.co.uk/blog/ the
same time its benefits and efficacy.These clinical trials must be completed
before a certain medicinal product is used in a hospital or sold in a local
pharmacy.The trials are performed in various stages, both on healthy humans and
on patients with a certain disease, but also after the product has been
launched, so that side-Effects and safety can be monitored during use at a large
scale.Whether or not the cra is involved in the whole clinical trial process
depends on each company and its policy.Some companies expect of the cra to go
through the whole process, from discussing with the doctor who has come up with
the idea for the clinical trial to writing reports after analysis completion.The
typical work activities of a cra include developing trial protocols and
presenting them to a steering committee, designing case record forms, seeing to
the wellbeing and safety of all trail subjects by maintaining coordination with
the ethics committee, assessing whether the facilities at a specific study
center are suitable, briefing doctors on how the trial is being conducted,
preparing study centers and making sure that the necessary trial materials are
present in each center.A cra is also responsible for monitoring the clinical
trial from beginning to end, including visiting study centers regularly,
collecting case record forms from hospitals, writing visit reports and filing
them along with other trial documentation, ensuring that all the supplies left
unused after the clinical trial has been completed are accounted for, closing
down all centers as soon as the trial has been completed, and sitting down with
a medical statistician to discuss the trial results.The preparation of final
reports and manuscripts for publications may also be asked of a cra.As a
clinical monitor, the cra must give considerable thought to how to monitor a
scientific study.The clinical monitor must pay regular visits to the study
center, since the occasions on which a clinical trial can be monitored
exclusively by telephone are extremely rare.Excellent communication skills are a
must for a clinical monitor, and so is the ability to have effective
relationship with his/her colleagues and the staff at the trial center.Since the
traditional paper files have been completely replaced by electronic records, the
clinical monitor must have it and administrative skills.Cra certification is
possible after completion of a cra training program, and in order to enter the
cra classes students must have a degree in medical sciences.There are several
subjects which are known to increase the students' chances of obtaining a cra
certification.These include biochemistry, biomedical science, anatomy, biology,
microbiology, molecular biology, toxicology, pharmacology, medicine, nursing,
etc.Leading educators such as unitek college offer cra certification.The need
for cras is increasing because governments all over the world have more and more
tightening regulations regarding new drug Licensing or drug re-Licensing.
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