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.
For a nurse to succeed in the oncology research domain, she must have good knowledge of oncology and the disease under study. Let us discuss some of the important responsibilities of a research nurse.
Research Nurse should be experienced with the phlebotomic procedures as she may have to administer intravenous drugs during the cancer trial. She should also be experienced in collection and preparation of blood samples for biochemical and pharmacokinetic analysis. Research Nurse should be aware of alternative medicine and treatment in emergency situations and should have knowledge of adverse drug reactions and their counter treatments. Good communication skills are needed to act as main line of communication at the site and between site and the sponsor. Regular training in ICH-GCP would keep the research nurse with the updated knowledge.
As GCP demands that every trial procedure is to be documented, the research nurse has to ensure the proper data collection process. She may have to encourage other personnel involved in the trial conduct to collect the accurate or error free data. In case of an inpatient study, the research nurse would be the most responsible person in conducting the trial after the principal investigator. Most of the time, the research nurse would be in more close contact with the patients than the regular physician. This helps in explaining the research study to the patients and to identify the potential eligible subjects so that they can be seen by the appropriate clinician and considered for the trial.
Thus a research nurse plays a vital and multi-functional role in conducting an oncology study at an investigational site. Although theoretically the relationship ends when the patient’s participation in the trial is complete, the research nurse may remain a key point of contact, especially in the absence of a clinical specialist.