What is clinical trial monitoring?
The purpose of implementing monitoring during the clinical trial is to ensure quality operation and data as well as trial efficiency. Sponsors should develop a clinical trial monitoring plan based on the benefit and protection of the subjects, along with the accuracy and completeness of the data, to ensure that the trial is conducted under appropriate monitoring. The sponsor would appoint the Clinical Research Associate (CRA) and choose site monitoring, system remote monitoring, or both.
As Communication Bridge between sponsor and investigators, the CRA should have enough clinical knowledge, a certificate of Good Clinical Practice and appropriate training for the clinical trial. When monitoring the clinical trial, the CRA is required to comply with the protocol and related clinical trial regulations.
According to the scope and nature of monitoring as determined by the sponsor, the CRA should monitor the following activities, such as the qualifications of investigators and related researchers, ensure compliance during the trial period, verify the accuracy and completeness of source data, and the data maintain properly.
In addition, to control the process and ensure the quality of the trial, CRA should continuously track the significant findings, deviations and deficiencies until the problems are fixed or the end of the trial.
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Reference: Regulations for Good Clinical Practice.