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.
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 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 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.
The monitor has to make sure each blood test, ECG, scan, and outcome measurement has been duly completed and accurately recorded. In big trials, the study team will make everything as automated as possible. On smaller trials, the study monitor will do a lot more of the heavy lifting. Computerization is as much about establishing an unambiguous audit trail as it is to make life easier on the CRA.
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 have an eye for detail and a methodical approach to work. Sometimes, the study team will implement a protocol amendment. The CRA has to make sure that none of the new procedures are performed on a subject until that site has the necessary regulatory and ethical approval for the amendment. At the end of the study, the CRA is responsible for making sure that each investigator has a copy of each subject's clinical trial record.
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 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 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.
The monitor has to make sure each blood test, ECG, scan, and outcome measurement has been duly completed and accurately recorded. In big trials, the study team will make everything as automated as possible. On smaller trials, the study monitor will do a lot more of the heavy lifting. Computerization is as much about establishing an unambiguous audit trail as it is to make life easier on the CRA.
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 have an eye for detail and a methodical approach to work. Sometimes, the study team will implement a protocol amendment. The CRA has to make sure that none of the new procedures are performed on a subject until that site has the necessary regulatory and ethical approval for the amendment. At the end of the study, the CRA is responsible for making sure that each investigator has a copy of each subject's clinical trial record.
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