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.
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.
The main reason for failure of a drug trial is because the study did not manage to recruit the prescribed number of patients. Each investigator must have a suitable pool of patients who will meet all of the inclusion criteria and none of the exclusion criteria specified in the protocol. For example, you would not expect a urologist to recruit many patients with Alzheimer's Disease.
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.
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.
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.
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.
The main reason for failure of a drug trial is because the study did not manage to recruit the prescribed number of patients. Each investigator must have a suitable pool of patients who will meet all of the inclusion criteria and none of the exclusion criteria specified in the protocol. For example, you would not expect a urologist to recruit many patients with Alzheimer's Disease.
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.
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.
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.
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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