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Clinical trial monitoring, typically headed by a clinical research associate, is oversight conducted to ensure the health and safety of patients participating in clinical trials of new drugs, treatments, or vaccines. Clinical trials are conducted once laboratory research into a drug, vaccine, or therapy has indicated its safety for human use. Trials explore whether the drug is effective on humans and notes adverse reactions among participants before the drug can be released to the public.
Monitoring includes the collection and analysis of data from the beginning of a trial through its conclusion to ensure that the methodology and results are valid. Clinical trials follow a protocol that lays out exactly what researchers will be investigating and doing throughout the study. The clinical research associate is usually accountable to an institutional review board, created when a clinical trial is launched, which periodically evaluates the progress and results of the trial. Clinical trial monitors evaluate whether trials are being conducting in adherence to local, national, and international law and good practice.
Clinical trial monitoring should adhere to standards of Good Clinical Practice (GCP), as provided by the The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This organization brings together regulators from Europe, Japan, and the US to provide global guidelines to improve safety in clinical trial monitoring. Clinical trial monitoring is often required by government agencies, such as the Food and Drug Administration (FDA) in the US, that approve pharmaceutical products for sale and use. Clinical trials may be sponsored by any number of government agencies, hospitals, universities, clinics, pharmaceutical companies, or biotechnology companies.
The sponsor of a particular trial will dictate the standard operating procedures for monitoring that trial. The sponsor also determines who will monitor the trial and how many monitors there will be. The frequency and length of site visits by the clinical research associate may vary according to the nature of the study, including the number of participants, the disease or condition being studied, and the complexity and risk of the drug or treatment. The clinical research associate prepares a plan for all activities that take place during a clinical trial monitoring visit. He or she usually writes a report after each visit.
The Center for Drug Evaluation and Research, part of the FDA, publishes an annual list of the most common failures cited in clinical trials. In the US, the Department of Health and Human Services agency that regulates clinical trials is the Office for Human Research Protections (OHRP). In addition to regulation and compliance, the OHRP offers educational resources and conferences for researchers.