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.
The new policy set by TFDA-Medical device management act
Due to the diversified development and types of medical device in recent years, it is gradually different from the drug management model. And the risk level of medical device is determined according to the classification and grading management.
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.
Obligation on icons and symbols to display for manufacturers of medical devices
EN ISO 15223-1:2021 has been updated and replace ISO 15223-1:2016 with the aim to improve definitions and descriptions through new symbols for comply with various regulatory requirements.
