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Building Capacity for the Nation’s Innovative Drug Development: A Milestone for the PUCRI

In 2007, the Mega Project on Drug Innovation and Development was initiated by 11 ministries and commissions, including the Ministry of Science and Technology, National Development and Reform Commission, and Ministry of Finance. Leveraging regions advanced in technology and industrial structure, China aimed to build a national new drug innovation technology system that provides technology support for innovative drug research and development (R&D), and to explore and establish new mechanisms and models for innovative drug R&D that are effective and suited to China's environment .

The Data Management Department at Peking University Clinical Research Institute (PUCRI)( was enlisted to participate in the Mega Project and build the data management platform for three large clinical research institutions—Peking University First Hospital, Third Hospital and the Chinese Academic of Medical Sciences Cancer Hospital/Cancer Institute. Under the strategic direction of building a clinical data management platform with international advanced technology, PUCRI set out to enhance the infrastructure of data management platform, build a talent pool, conduct data management software training, deploy pilot studies, establish guidelines and disseminate advanced concepts in data management through the exposure to and adoption of advanced international electronic data capture systems.

Infrastructure: The Data Management Department was established by PUCRI on May 30, 2009 with the support of the Peking University Health Science Center to lead this data management platform project. To date, the department has been equipped with leading-edge office equipment, data storage servers and a network environment.

Data Management Talent Pool: To support this major project,  PUCRI attracted and  nurtured professionals in the data management industry through internal training and external recruitment. The team, now comprised of seven full-time professionals, includes two doctorates, one master, two bachelor and two college graduates. With a scientific approach to attracting, nurturing and managing skilled professionals, PUCRI has created a robust environment for fully leveraging their talent pool.

Software Implementation and Training: The objective of the data management platform project is to build a highly effective yet secure electronic data capture system. PUCRI formed a strategic partnership with Medidata Solutions (, a leading global provider of SaaS-based clinical development solutions, and established the Medidata Center for Clinical Research Technologies at Peking University. The center adopted the Medidata Rave® 5.6 clinical data management system and has received training on this platform. PUCRI professionals can utilize major modules, perform basic operational processes and can independently build a clinical data management system on Medidata Rave.

SOP Development: PUCRI established a set of standard operating procedures and standardization documents, including standard operating procedures for SOP management, data management plan, user management, protocol and CRF evaluation, CRF amendment tracking, lab data management, data entry process, blinding evaluation, data locking and transfer, and query management. These procedures and documents ensure the effectiveness of data management.

Pilots: Collaborating closely with the Peking University First Hospital, PUCRI implemented a data management program for neuro diseases clinical trials using Medidata Rave as the clinical data capture and management platform. The platform features:
1. Easy-to-use remote electronic data capture (EDC) accessible via web browser (no software installation required)
2. Real-time and remote monitoring, evaluating and correcting of protocol deviations by sponsors and investigators
3. Remote source document verification (SDV) for correcting data entry errors by clinical research coordinator
4. Real-time query management
5. Automatic audit trail for data modification
6. Electronic capture and communication of unexpected events
7. Multiple configurable levels of data locking
8. Extensive reporting options, with standard, ad hoc and customizable reports
9. On-demand, interim analysis through real-time data extraction in multiple industry standard formats, including SAS, CSV (MS Excel) and CDISC ODM

PUCRI is also collaborating with the Chinese Academy of Medical Sciences Cancer Hospital to build the “Cancer Clinical Research Data Management Platform.” The protocol and CRF evaluation have been completed and the project is moving into the database infrastructure development stage.

Dissemination of Advanced Data Management Concepts: To expedite the introduction of advanced data management concepts and methodologies, PUCRI has been collaborating with Medidata Solutions and has already conducted four “Distinguished Speaker Series” in clinical data management. The “Distinguished Speaker Series” draws electronic data management thought leaders from the United States, government officials from SFDA and well-known domestic subject matter experts to introduce international advanced concepts of electronic clinical trials and share domestic progress in adopting and utilizing EDC. To date, more than 500 attendees with broad representation from medical schools, research institutions, pharmaceutical companies and students have responded positively to the series.

With the growth of the Data Management Department, establishment of a talent pool and maturity of the data management system, we believe the Data Management Department in PUCRI will continue to serve domestic and international medical schools, academic institutions, hospitals and life science enterprises with high quality clinical data management services that are in compliance with international standards, and contribute to the advancement of clinical research in China.

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