The Standardization of the CDISC Compliant Data Creation Process in CRO

Abstract

Each organization has been working on the standardization of the CDISC compliant data creation process toward “Electronic Submission of Study Data for New Drug Applications” after April 2020, and those experiences have been accumulated. However, there are cases where rework sometimes occurs due to differences in policies of the procedures and quality standard among organizations and persons in charge. Therefore, it can be said that there are still remaining challenges in the process of forming a common understanding on both sides of the sponsor/CRO before the start of outsourced work. From the questionnaire survey results on the internal systems and issues for Electronic Study Data Submission support services, which were carried out on the member companies of the Japan CRO Association, it was confirmed that standardization of the CDISC data creation process generally contributed to operational efficiency. On the other hand, the types of work that had not been standardized at that time, such as Electronic Study Data Submission support and clinical pharmacology, became clear as well. To address this situation, Japan CRO Association CDISC Team examined considerations to provide high-quality Electronic Study Data Submission-related services efficiently, as well as to standardize its processes on each side of the sponsor and CRO. Items to be checked at each stage of work have put together in our checklist for building a smooth relationship between sponsor and CRO, so that it can be used to define scope of outsourcing work, division of roles, and agreement of required quality, and to reflect them in operation procedure.