Clinical Research Online Course
Based on ICH-GCP guidelines definition, essential documents are “those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced”. 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…
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…
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…
A clinical study protocol is a document that indicates how the clinical trial is going to be conducted. Clinical Project Managers and Clinical Research Associates (CRAs) usually work on one study/protocol at a time. They also need to train clinical sites and answer questions from PI or study staff; so,…
If you are planning to enter clinical research field and you don’t have experience working with the software used in this area you don’t need to be worry. Remember the first time you had to start working with a new software, how did you learn about it? training? watching videos on Youtube?…
If you are thinking of becoming a Clinical Research Coordinator or have an interview coming up for this role; here are 5 important transferable skills, you need to consider. Verbal Communications One of the most important skills you need to have for this position is to be able to communicate…