Creating, Training, and Implementing the Safety Reporting Processes for a Research Organization’s New Clinical Trials Program
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Technology is shifting the paradigm of clinical research operations with new non-clinical staff assisting in the conduction of clinical research by helping to create and oversee the programming and capturing of big data. Due to the 21st Century Cures Act focusing on the use of real-world data and real-world evidence, both clinical and non-clinical research staff may be involved in patient safety reporting and necessitate proper training to understand their roles and responsibilities for the proper handling of patient safety reporting. A new research organization (NRO), which currently acts as a healthcare IT company geared towards clinical research, is in this current situation. With the company’s focus on eventually conducting their own pragmatic clinical trials, the regulatory team is anticipating the need for staff training as well as the creation of internal controls to meet all Federal regulations. Patient safety was at the top of the team’s list to address; it was determined that a training program needed to be created. FDA and EMA regulations were reviewed to gain a better understanding of the patient safety reporting guidelines, and to also see if either regulatory agencies provided requirements or guidance on the proper training of staff on patient safety reporting. The FDA’s Code of Federal Regulations did not provide regulations specifically for staff training, nor were resources made available for institutions to utilize. On the other hand, the EMA’s GVP: Module VI addressed staff training requirements on patient safety, including both clinical and non-clinical staff. The EMA also provides a very resourceful website hub of training materials, which institutions may utilize. National and international institutions were reviewed to find trends and obtain training program ideas. Many institutions use SOPs and training slides as their standard training methods, which still do not compare to the EMA’s abundance of resources. The researcher concluded that the FDA must not only provide further regulations surrounding RWD and RWE, but that the finalized Cures Act should include safety reporting and proper staff training. In order to get ahead of the future regulations, the researcher recommended that the NRO create a general, company-wide training and role-specific training program, complete with training slides, live and recorded training presentations, and to have this program accessible to staff at all times.