The term "Good Clinical Practice" is an international quality standard that is applied to interventional trials. In an interventional study, subjects are assigned to a group of people to receive a treatment, usually either a drug or a medical device, or to a control group receiving existing treatment or no treatment. Clinical research associates, also known as trial monitors, play a pivotal role in maintaining the integrity of the trial data and the safety of the patients who are participating.
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 manager will have prepared a questionnaire or pro forma that the monitor uses to determine whether the site and the investigator are suitable for the trial being conducted. They need to have a detailed knowledge of the study protocol. The monitor will closely examine both the investigator himself and the prospective trial site.
One of the most common reasons for a trial failing to complete on time and within budget is an inability to recruit the necessary numbers of subjects. Therefore, one of the most important criteria for a study site is that it has a large pool of patients who are diagnosed with the condition under examination. If a company was testing a drug or a device to be used in patients with gallstones, they would aim to recruit general surgeons who specialize in treating the gallbladder. They would not recruit general surgeons to trial an intervention in Alzheimer's Disease.
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.
One of the main tasks of a study monitor is to verify the recorded data. They go through patient records and make sure all of the requisite tests have been performed as detailed in the study protocol and that they have been faithfully documented in the trial literature. They have to make sure that the subject's name or other personally identifying information will be invisible to the study team.
Every compound has a range of temperatures at which it is stable. The temperature of the clinical trial supplies has to be validated at every step of the trial. Competent authorities (the FDA in the United States) can invalidate an entire trial if it is not conclusively recorded that the study drug did not veer outside the specified temperature range.
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.
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 manager will have prepared a questionnaire or pro forma that the monitor uses to determine whether the site and the investigator are suitable for the trial being conducted. They need to have a detailed knowledge of the study protocol. The monitor will closely examine both the investigator himself and the prospective trial site.
One of the most common reasons for a trial failing to complete on time and within budget is an inability to recruit the necessary numbers of subjects. Therefore, one of the most important criteria for a study site is that it has a large pool of patients who are diagnosed with the condition under examination. If a company was testing a drug or a device to be used in patients with gallstones, they would aim to recruit general surgeons who specialize in treating the gallbladder. They would not recruit general surgeons to trial an intervention in Alzheimer's Disease.
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.
One of the main tasks of a study monitor is to verify the recorded data. They go through patient records and make sure all of the requisite tests have been performed as detailed in the study protocol and that they have been faithfully documented in the trial literature. They have to make sure that the subject's name or other personally identifying information will be invisible to the study team.
Every compound has a range of temperatures at which it is stable. The temperature of the clinical trial supplies has to be validated at every step of the trial. Competent authorities (the FDA in the United States) can invalidate an entire trial if it is not conclusively recorded that the study drug did not veer outside the specified temperature range.
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.
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