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 team provides the CRA with a list of questions that need to be answered about the site. For this reason, the monitor needs to be thoroughly versed in every aspect of the trial protocol. A trial protocol is a document that contains all of the tests and procedures that each subject in the trial has to undergo. Everything that happens to a patient has to be specified in the protocol and carefully documented in the study literature.
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.
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 team provides the CRA with a list of questions that need to be answered about the site. For this reason, the monitor needs to be thoroughly versed in every aspect of the trial protocol. A trial protocol is a document that contains all of the tests and procedures that each subject in the trial has to undergo. Everything that happens to a patient has to be specified in the protocol and carefully documented in the study literature.
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.
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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