Specifications include, but are not limited to: The selected e-reg/e-source system will need to provide regulatory document and patient clinical trials management as well as reports that are consistent with the needs and scope as mandated and as amended by the National Cancer Institute (www.nci.nhi.gov). The day-to-day management of clinical trials records and data need to abide by FDA regulations, the International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH guidelines) and clinical safety data management. The software will also need to be compatible with present enterprise solutions within the University of New Mexico Health Sciences Center (UNMHSC) and the UNMCCC and must be able to interface (i.e. exchange data safely and reliably) with established systems.
