Notice on Soliciting Opinions on technical guidelines for data management of clinical trials, technical guidelines for electronic data collection (EDC) of clinical trials and guidelines for planning and reporting of data management and statistical analysis of drug clinical trials

Source: CDE 2016-2-2 In order to guide the standardized management of clinical trial data of drugs in China, strengthen the standardization of clinical research of drugs, and ensure the authenticity, integrity and standardization of clinical trial data from the source, our center has drafted and formulated the technical guidelines for clinical trial data management in accordance with the international general specifications and technical requirements, combined with the practice of clinical trial data management and statistical work in China , technical guidelines for electronic data collection (EDC) in clinical trials and guidelines for planning and reporting of data management and statistical analysis in drug clinical trials are now open for comments Deadline for consultation: March 15, 2016 We sincerely welcome all sectors of the society to put forward valuable opinions and suggestions on the draft and give us timely feedback Your feedback can be submitted according to the following path: click the "guidelines for comments" column on the center website, click the corresponding guidelines, fill in your comments in the dialog box, and click confirm to submit You can also send your comments to the contact person's email: Wang Jun (wangj@cde.org.cn) Thank you for your participation and support Appendix 1: guidelines for planning and reporting of data management and statistical analysis of drug clinical trials (Draft for comments) Doc Appendix 2: guidelines for planning and reporting of data management and statistical analysis of drug clinical trials (Draft for comments) PDF Appendix 3: electronic data collection of clinical trials (EDC) ）Technical guidelines (Draft for comments) drafting instructions Doc Annex 4: technical guidelines for electronic data collection (EDC) of clinical trials (Draft for comments) PDF Annex 5: drafting instructions and re comments of technical guidelines for clinical trial data management Doc Annex 6: Technical guide for clinical trial data management.pdf