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.
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 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 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.
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 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 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.
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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