The Job Of Clinical Research Associates In Drug Trials
Good Clinical Practice is a term applied to the international quality standard that governs the running of interventional research trials. In an interventional setting, subjects are administered either a test substance, a control drug that is currently the gold standard in that particular therapeutic indication, or a placebo, a carefully matched compound that has no pharmaceutical activity whatsoever. It is the job of clinical research associates to make sure that each study complies with the international standards of good clinical practice.
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.
All drugs have a range of temperatures at which they are stable and functional. For every minute during the study, the temperature of the clinical study material (drug) has to meet these criteria. The monitor is responsible for making sure the drug has had no excursions outside the prescribed temperature range.
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.