Shandong University QILU Hospital All Rights Reserved

Notice on carrying out clinical research and investigation in hospital

Updatetime:2020-09-28 15:31:59     From:

Each department:

 
According to the notice of Shandong health and Health Commission, according to the requirements of the notice on carrying out clinical research and investigation in medical institutions issued by the general office of the National Health Commission (Guo Wei ban Ke Jiao Han [2019] No. 902), the investigation and statistics of clinical research in our hospital are carried out.
 
1、 Research scope:
1. The clinical research projects under research initiated by our hospital's medical staff as the main researchers, not for the purpose of product registration, but with clinical intervention measures, include the projects that have passed the ethical review and project filing according to the relevant clinical research project management requirements, but have not yet been completed, excluding basic medicine and applied basic medicine research projects.
 
2. Clinical research projects initiated by researchers in medical institutions with "stem cells, somatic cells, gene therapy, xenotransplantation, use of drugs or medical devices beyond product instructions (including combination drugs without safety data)" as clinical intervention measures.
 
3. Other clinical research projects with clinical intervention measures initiated by researchers that need to be reported.
 
2、 Research methods:
Project leaders of clinical research projects with "stem cells, somatic cells, gene therapy, xenotransplantation, use of drugs or medical devices beyond product instructions" as clinical intervention measures, please log into the medical research registration information system before February 14, 2020( http://114.255.48.20 For the guidance, please refer to the homepage of the system). The information of other clinical research projects under study can be postponed to March 20, 2020.
 
3、 Application for medical research registration information system account number:
Please download the new account information form of Appendix 1 medical research registration and filing information system, fill in the form completely and send it to the email of clinical research center sddxlcyjzx@163.com For account registration. (the initial password is: a123456, please complete the registration before logging in
Please contact the scientific research department for specific information and the matters not covered in the relevant process.
Contact person: Chen Hui 82166953
Appendix 1 new account information form of medical research registration and filing information system.xls