Sunday, April 10, 2016

The Role Of Clinical Research Associates In Good Clinical Practice

By Jose Meyer

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 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 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.

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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