Effectiveness analysis of the clinical research coordinators management carried out by drug clinical trial institutions / 中华医学科研管理杂志

ABSTRACT

Objective:To analyze the problems existing in the management mode of clinical research coordinator (CRC) in the new context, propose improvement measures and analyze the effectiveness of improvement.Methods:Four types of stakeholders related to CRC, including investigators, clinical research associates(CRA), institutional managers and human subjects were investigated in regular monthly questionnaire survey on the basis of CRC management comparasionat home and abroad. The new CRC management countermeasures implemented by our institution in July 2020 were taken as the time node, and the data from January to June 2020 were taken as the pre-implementation group, and the data from July to December 2020 were taken as the post-implementation group. Compare the monthly scores of CRCs′ work effect for 30 projects in the institution before and after the implementation of such countermeasures.Results:The scores of CRCs′ working effectiveness were improved after the implementation of CRC management countermeasures, whcih including standardizing the entry of CRC, updating of the training and assessment mechanisms, conducting regular communication meetings and developing reward and punishment measures. The scores from investigators increased by 20.17%, scores from CRAs increased by 11.54%, scores from institutional managers increased by 14.26%, scores from subjects increased by 10.64%, and the total scores increased by 14.13%( P<0.01). Conclusions:Countermeasures to optimize CRC management taken by drug clinical trial institutions can significantly improve CRCs′ working effectiveness in multiple dimensions.