Lu, Yang
Mao, Peng
Wang, Guihuai
Tao, Wei
Xiong, Donglin
Ma, Ke
Li, Rongchun
Feng, Dan
Duan, Wanru
Li, Shun
Fu, Zhijian
Feng, Zhiying
Jin, Yi
Wan, Li
Lu, Yan
Zhang, Daying
Fan, Bifa
Wang, James Jin
Li, Luming
Funding for this research was provided by:
The National Key Research and Development Program of China (2016YFC0105502)
National Natural Science Foundation of China (81527901)
Beijing New-star Plan of Science and Technology Program (Z181100006218129)
Article History
Received: 24 December 2019
Accepted: 24 September 2020
First Online: 7 October 2020
Ethics approval and consent to participate
: The CITRIP study received ethical approval from the Clinical Trial Ethics Committee of China-Japan Friendship Hospital, covering all participating sites. Important changes to the protocol will be submitted to the Ethics Committee for review. If any modifications of the protocol are approved, the sponsor and funder should be notified first then the PI will notify the centers. A copy of the revised protocol will be sent to the PI to add to the Investigator Site File. Informed consent will be obtained from all participants in the trial. On the consent form, participants will be asked if they agree to the use of their data or choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities.
: Consent forms for the trial include consent for publication of results in peer-reviewed journals. The results will be reported at conferences and in peer-reviewed publications. The first publication will be based on data from the participating centers and will be analyzed with statisticians’ supervision. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors.
: Primary investigator’s grants in this trial are supported by the sponsor. No additional reporting is allowed until the final report of the trial is completed, with the exception of consent by the sponsor. Information on the sponsor’s and investigator’s publishing policies will be described in their clinical trial contract.