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 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.
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.
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.
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.
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 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.
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.
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.
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.
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