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.
What is ISO and ISO 13485?
ISO is an independent international organization established in 1947 with a membership of 169 national standards bodies. ISO develops and publishes international standards. Until now, ISO has published over 20,000 international standards, covering technology, management, manufacture, etc. Each international standard will be updated and revised according to the current situation, and the year of publication will be added after the name of the guidelines. However, ISO is not responsible for institutional certification which external certification agencies perform.
Clinical Trial Phases
Clinical trials are used to determine the influence after human take drugs, medical devices or treatments. Clinical trials have multiple phases, that build on one another. Each phase helps answer different questions about the new drugs/medical devices/treatment and needs to be completed successfully before moving on to the next phase.
What is an Electronic Data Capture (EDC) System?
Many clinical data be collected and recorded in clinical trials, such as personal health record (PHR), informed consent form (ICF), clinical trial visit record or lab data etc. In the past the clinical data recorded on paper which is traditional CRFs. With traditional CRFs, it can’t assure data reliability (unintentionally modification) and security (loss paper) cause the processing of data collection and management will become slower.
Summary of acronym list in clinical trial
A clinical trial is trial conducted with patients, evaluating new treatments, drugs or devices, in patients. They can also test improved procedures of treating, preventing, screening and diagnosing disease in patients.