Clinical Research Online Course
If you are looking for clinical research positions and have no experience in terms of clinical trial management systems (CTMS), in this article you will be able to understand how this system facilitates the process of monitoring. Before moving to how the CTMS helps the clinical research associate (CRA), let’s…
The Informed Consent Form (ICF) is one of the documents that is reviewed by the CRA during the monitoring visit. It is the CRA responsibility to ensure that the patient (subject) has been consented, appropriately. If the consent is not signed or completed properly, additional training for the Clinical Research…
Base on ICH-GCP guidelines Institutional Review Boards (IRBs) are responsible for conducting ethical review of the study protocol. In clinical trials, patient safety is the first priority and therefore IRB responsibility is to make sure that the study protocol is ethical and the study staff/PIs are well trained and qualified…