Medical Information
Medical Monitoring
Operation management of DSMB/CEC
Design/writing/consulting of medicine Phase I-IV clinical research protocols
Design/writing/consulting of research protocols for medical instrument beds
Design/writing/consulting of real-world and international multi-center clinical research protocols
Writing of summary report of clinical research
Design/writing of informed consent form, research medical record and case report form.
Writing of researcher's manual
Prepare medical monitoring plans
Review the eligibility of subjects
Medical review of AE/SAE  
Medical review of concomitant medication
Medical review of deviation/violation of protocols in the research process
Medical review of medical coding in the research process
Medical review of EDC input data
Query solving from the perspective of medical specialty
Medical review of the documents in the research process
Writing of the management plan of pharmacovigilance for SUSAR
Confirmation of known adverse reactions of products
Establishment and maintenance of security database
Receiving, input, coding, duplicate checking, review and medical evaluation of SAE during clinical trials
Medical review and report of SUSAR during clinical trials
Quality control, communication, follow-up and problem solving of SAE/SUSAR report
Writing of Development Safety Update Report (DSUR)
Preparation of DSMB/CEC Committee
Writing of articles of association of DSMB/CEC
Safety events/clinical events, collection and analysis
Review by members of Coordination Committee
Summary and report of review results
? Clinical research on 150+ drugs
? Clinical research on 100+ medical devices
? Participate in CHANCE Research initiated by Professor Wang Yongjun from Beijing Tiantan Hospital during the whole course
? Be responsible for the first international multicenter clinical research initiated by the Chinese hospital