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…
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…
Several clinical trials require specific lab tests. Depending on the study protocol the lab tests are required to establish inclusion and exclusion criteria, monitor the safety of the patients enrolled in the study or demonstrate the efficacy of the investigational product (IP). The sponsor/CRO has two options for gathering clinical…