The Job Of Clinical Research Associates In Drug Trials
by Jose Meyer
Before a drug or other medical intervention is placed in the marketplace, it must undergo rigorous testing, first in the laboratory and then in humans, or the clinical setting. Clinical study monitors, also known as <a href="http://www.discoveryclinicalresources.com">clinical research associates</a>, play a critical role in making sure the trial data are valid and that the rights of the patients participating in the study are protected.
The role of the CRA begins long before the first patient visit takes place. In study feasibility, monitors do the legwork involved in the selection of study sites. Usually, the study management team produces a shortlist of potential trial investigators. These are usually leaders in their fields, or key opinion leaders. It is the task of the CRA, or trial monitor, to visit each site to determine its suitability for the study.
The study management team will usually have produced a pro forma that the monitor can work from to see if the site has the right personnel and facilities to successfully complete their part of the study. This means the monitor must know the study protocol from start to finish and back again.
One of the biggest reasons why clinical studies fail is because the team did not recruit enough patients. A suitable trial investigator has to have a large enough population of patients from which to select study candidates. In a study of treatments for dementia, it is unlikely the study team would want to recruit a pediatrician.
Once a study is underway, every thing that happens to every patient enrolled in that study must be carefully monitored and validated. Trials can have thousands of subjects enrolled at hundreds of investigators in dozens of countries. Every detail of every visit mentioned in the trial protocol must be accurately documented.
Periodically, the CRA has to visit each investigator's site and compare the subjects' medical notes with the trial documentation to make sure there no gaps or mistakes. They also have to be vigilant that none of the subjects' names or other personally identifying material is visible to any of the study management team.
The CRA will also have to make sure that the compound under investigation is not stored outside its prescribed temperature range. Regulatory authorities will now allow data gathered from a compound that ventures above or below the recommended temperature. This is because too high or too low a temperature may render the compound ineffective or even toxic.
A CRA has to be almost fanatical about details. In order for a completed study to give a faithful answer to the question being asked, every item of data must be completed. If a blood test result listed in the protocol is not available, the CRA must document why.
If you are looking for information about <a href="http://www.discoveryclinicalresources.com">clinical research associates</a>, go to our web pages online here today. Further details are available at http://www.discoveryclinicalresources.com now.
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New Unique Article!
Title: The Job Of Clinical Research Associates In Drug Trials
Author: Jose Meyer
Email: nathanwebster335@live.com
Keywords: clinical research associates
Word Count: 460
Category: Medicine
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