Role of Research Nurse in Oncology Clinical Trials
ICH-GCP guidelines govern the clinical trial conduct and ensure the protection of patient’s safety and well-being and also ensure that the data collected during the course of clinical trial is accurate and of high quality. For every clinical trial taking place at the investigative site, a clinical research coordinator (CRC) is the main line of communication for most of the activities carried out. A CRC performs many activities such as maintaining source documentation, patient follow-up, CRF filling etc.
In case of an oncology study, the Research Nurse (RN), would best suit for the role of a clinical research coordinator role as he/she is experienced in most of the trial procedures being carried out in the wards. The research nurse plays a vital role in maximizing patient recruitment and in making sure that both the trial protocol and GCP guidelines are closely followed by everyone involved in the trial.







Clinical trials are systematic studies conducted in human subjects to determine the safety and efficacy of a new drug. The purpose of clinical trials is to find out the safer, more effective drugs or methods or therapies to screen, prevent, diagnose or treat a variety of diseases. These studies follow strict scientific standards, thus protect the patients and help to produce reliable study results. Clinical trials are composed of various steps mainly categorized into 4 phases; each phase is designed to find out specific information and each new phase of a clinical trial builds on information from previous stages. Clinical trials must apply the pharmacological principles/ techniques in order to study the mechanism of action of drugs in humans. This is simply known as clinical pharmacology.