From: Quality problems of clinical trials in China: evidence from quality related studies
Subject | Number | Item |
---|---|---|
Ethics committee configuration | 1 | Unreasonable number and composition of the ethics committee [11, 13, 20, 24, 26, 30] |
2 | Inadequate capacity of ethics committee members [7, 17, 26, 27, 29, 30] | |
Implementation | 3 | |
4 | Incomplete review and nonstandard records [21] | |
5 | Nonstandard documentation and qualification management [19] | |
6 | Ignoring follow-up reviews and ethical acceptance check [22, 27] | |
7 | No rigorous program review [25] | |
8 | Inadequate consideration of ethical issues (such as subsidy for participants, wash-out time, procedures for reporting serious adverse events) [25] | |
9 | Insufficient ethical consciousness of researchers [22] |