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 management team will usually have produced a pro forma that the monitor can work from to see if the site has the right personnel and facilities to successfully complete their part of the study. This means the monitor must know the study protocol from start to finish and back again.
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 a study is underway, every thing that happens to every patient enrolled in that study must be carefully monitored and validated. Trials can have thousands of subjects enrolled at hundreds of investigators in dozens of countries. Every detail of every visit mentioned in the trial protocol must be accurately documented.
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 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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