Good Clinical Practice is a term applied to the international quality standard that governs the running of interventional research trials. In an interventional setting, subjects are administered either a test substance, a control drug that is currently the gold standard in that particular therapeutic indication, or a placebo, a carefully matched compound that has no pharmaceutical activity whatsoever. It is the job of clinical research associates to make sure that each study complies with the international standards of good clinical practice.
Trial monitors get involved in every aspect of the operational aspects of trials from feasibility to study closeout. Before a single patient is recruited, monitors help with study center selection. The names of the investigators, who are usually key opinion holders in their fields, will have been narrowed down by the study management team. The monitors are responsible for visiting each investigator's clinic to begin the process of study center selection.
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 patient is enrolled into the trial and has signed their consent form, everything from that point on must be accurately written down in the trial documentation. These days, most trial documentation is done online on computerized forms. There used to be a time when the monitor had to look at the medical records and compare them to the handwritten forms to make sure the info was completely accurate.
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.
All drugs have a range of temperatures at which they are stable and functional. For every minute during the study, the temperature of the clinical study material (drug) has to meet these criteria. The monitor is responsible for making sure the drug has had no excursions outside the prescribed temperature range.
One of the main qualities of a successful research study monitor is a keen eye for details. Every piece of data has to be recorded correctly and nothing must be missing. It can get very interesting when the study team implements protocol amendments. The monitor has to keep track of the dates these amendments have been approved by both the regulatory authorities and the ethics committees.
Trial monitors get involved in every aspect of the operational aspects of trials from feasibility to study closeout. Before a single patient is recruited, monitors help with study center selection. The names of the investigators, who are usually key opinion holders in their fields, will have been narrowed down by the study management team. The monitors are responsible for visiting each investigator's clinic to begin the process of study center selection.
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 patient is enrolled into the trial and has signed their consent form, everything from that point on must be accurately written down in the trial documentation. These days, most trial documentation is done online on computerized forms. There used to be a time when the monitor had to look at the medical records and compare them to the handwritten forms to make sure the info was completely accurate.
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.
All drugs have a range of temperatures at which they are stable and functional. For every minute during the study, the temperature of the clinical study material (drug) has to meet these criteria. The monitor is responsible for making sure the drug has had no excursions outside the prescribed temperature range.
One of the main qualities of a successful research study monitor is a keen eye for details. Every piece of data has to be recorded correctly and nothing must be missing. It can get very interesting when the study team implements protocol amendments. The monitor has to keep track of the dates these amendments have been approved by both the regulatory authorities and the ethics committees.
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