Clinical Research Online Course
Feasibility assessment is a critical step in conducting a successful clinical trial. Selecting the right site can be beneficial for both the sponsor and the clinical site. In addition, it can provide an opportunity for many patients to be enrolled in a study that may change their life. Therefore, the…
Clinical Research Associates (CRAs) also called clinical monitors or trial monitors are the ones who are responsible to oversee the clinical trials on behalf of the sponsor. They have several responsibilities including but not limited to Source Data Verification (SDV), Source Data Review (SDR), writing reports, scheduling monitoring visits, and…
A Note to File (NTF) is a record that allows the clinical site and the sponsor to document an identified issue or discrepancy during a clinical study. A NTF should include the following items: · The root cause of the discrepancy/issue · The corrective action taken to prevent its recurrence · Explanation of…
For all clinical trials involving human beings, informed consent is mandatory however, in certain conditions the IRB might waive the informed consent. The Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA) are two major roles in clinical research that deal with consent forms. In this article I will discuss…