Discussion of the process of conducting an investigator-initiated research
- VernacularTitle:研究者发起的临床研究实施流程探讨
- Author:
Wei DAI
1
;
Xing WEI
1
;
Yaqin WANG
1
;
Yangjun LIU
2
;
Jia LIAO
1
;
Shaohua XIE
1
;
Bin HU
1
;
Hongfan YU
3
;
Yang PU
3
;
Wei XU
3
;
Yuqian ZHAO
4
;
Fang LIU
5
;
Xiaoqin LIU
1
;
Xiang ZHUANG
1
;
Biyu SHEN
6
,
7
;
Shaoping WAN
4
;
Qiang LI
1
;
Qiuling SHI
8
,
9
Author Information
1. Department of Thoracic Surgery, Sichuan Cancer Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 610041, P. R. China
2. Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, 17177, Sweden
3. School of Public Health, Chongqing Medical University, Chongqing, 400016, P. R. China
4. Department of Science and Technology, Sichuan Cancer Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 610041, P. R. China
5. Department of Chinese and Western Medicine, Sichuan Cancer Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 610041, P. R. China
6. Department of Nursing, Shanghai Children'
7. s Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, P. R. China
8. 1. Department of Thoracic Surgery, Sichuan Cancer Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 610041, P. R. China
9. 3. School of Public Health, Chongqing Medical University, Chongqing, 400016, P. R. China
- Publication Type:Journal Article
- Keywords:
Investigator-initiated research;
implementation process;
database;
standard operating procedure;
data management
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2023;30(02):299-304
- CountryChina
- Language:Chinese
-
Abstract:
The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.
