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.
Also known as trial monitors, they liaise with the site investigators and the central study team from the feasibility stage to the closure of study sites at the completion of the trial. During the feasibility stage, they compare the qualifications of the potential investigators with what is specified in the trial protocol to make sure the investigator has a good chance of completing the trial in accordance with GCP.
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.
The main reason for failure of a drug trial is because the study did not manage to recruit the prescribed number of patients. Each investigator must have a suitable pool of patients who will meet all of the inclusion criteria and none of the exclusion criteria specified in the protocol. For example, you would not expect a urologist to recruit many patients with 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.
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.
Also known as trial monitors, they liaise with the site investigators and the central study team from the feasibility stage to the closure of study sites at the completion of the trial. During the feasibility stage, they compare the qualifications of the potential investigators with what is specified in the trial protocol to make sure the investigator has a good chance of completing the trial in accordance with GCP.
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.
The main reason for failure of a drug trial is because the study did not manage to recruit the prescribed number of patients. Each investigator must have a suitable pool of patients who will meet all of the inclusion criteria and none of the exclusion criteria specified in the protocol. For example, you would not expect a urologist to recruit many patients with 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.
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.
About the Author:
If you are looking for information about clinical research associates, go to our web pages online here today. Further details are available at http://www.discoveryclinicalresources.com now.
No comments:
Post a Comment