Reflection of quality management of conducting international cooperative academic clinical research in China

Abstract

Objective Through summarizing quality management practices of international cooperative academic clinical studies funded by Peking University Health Science Center, analyzing its present major challenges of implementation in China, this paper proposed related measurements and suggestions to improve the quality of clinical research. Methods To sort the project management archive data, as well as descriptive analysis of the common monitoring/auditing findings. Results From the year 2011 to 2016, there were 14 such studies funded by Peking University health science center, common findings during monitoring and or auditing were classified as following categories, study files problem (100.0%), ethics problem (71.4%), protocol noncompliance (64.3%), data quality issues (71.4%), communication problem in study teams (14.3%), export problems of bio-specimens (14.3%), recruiting delay (14.3%) and cooperation termination in advance (7.1%). Conclusions In order to obtain credible and reliable data, peer recognized research conclusion and accurate answered scientific questions, it is essential for investigators to comply with laws and regulations and being strongly supported. Furthermore, researchers also need to establish and strictly follow study protocols, standard operating procedures (SOPs), research quality management system and relevant national laws and regulations that are comply with actual requirements in China. Key words: International cooperation; Academic; Clinical research; Quality management