Clinical Research Online Course
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…
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…
Based on ICH-GCP guidelines definition, essential documents are āthose documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data producedā. In order to successfully manage a clinical trial, it is critical to file the essential documents in a timely manner. The…
Clinical Research Associates (CRAs) have several responsibilities. Source Data Review (SDR) and Source Data Verification (SDV) are the most common tasks that CRAs perform during a monitoring visit. SDV is basically conducted to compare Case Report Form (CRF) to source data. SDR is a review of source documentation to check quality…