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 clinical research associates, 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 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 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 the site is initiated into the trial, every action that happens to every patient enrolled in the study must be carefully checked against the protocol. Every piece of data needs to be in place, or there needs to be a satisfactory explanation why it isn't. This is a huge job, as there may be several subjects enrolled at each one of hundreds of study sites in dozens of different countries all over the world.
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.
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.
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 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 the site is initiated into the trial, every action that happens to every patient enrolled in the study must be carefully checked against the protocol. Every piece of data needs to be in place, or there needs to be a satisfactory explanation why it isn't. This is a huge job, as there may be several subjects enrolled at each one of hundreds of study sites in dozens of different countries all over the world.
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.
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.
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