Consideration from Protocol Draft as a Deliverable of Multidisciplinary Cooperative Workshop

Abstract

The quality of clinical research design can be improved in a way by involving support-professional in charge of Quality Control (QC) and Quality Assurance (QA) since the initial stage of the research. The second way is to introduce the concept of Quality by Design (QbD) to propose research designs in view of the future and cooperate with researchers. Thus, in addition to strengthen the support function for the construction of research plan designs, each support-professional must collaborate with researchers since the early planning stage to formulate research plans, thereby ensuring the quality of the research process and deliverables. We participated in a multidisciplinary collaborative workshop. The purpose of this workshop was “creation of an efficient multi-professional collaborative educational program and development of an effective multi-professional collaborative clinical study workshop utilizing the linkage of occupation-specific and cross-cutting core competencies (Principal Investigator: Shoji Sanada)” in the “investigation and business summary of the multidisciplinary workshop” as the 2nd year of Reiwa Central Institutional Review Board Promotion project in Japan Agency for Medical Research and Development (AMED). We had brushed up the protocol synopsis in this multi-professional collaborative workshop, further revised it, and made a draft protocol with the workshop members. We expect that this study will help to build a multidisciplinary educational program in this project.