Your browser doesn't support javascript.
loading
Ethics Committee' s Management of Noncompliance/Violation or Protocol Deviation Report in Clinical Research / 中国医学伦理学
Chinese Medical Ethics ; (6): 328-331, 2018.
Artigo em Chinês | WPRIM | ID: wpr-706091
ABSTRACT
With the promulgation of a series of laws and regulations in our country, the requirement for stand-ardized management of clinical research process are gradually clear, and higher requirements on the following-up review management of ethics committee also are put forward. Through concluding and summarizing 128 noncompli-ance/violation or protocol deviation reports accepted by a hospital in recent two years, this paper analyzed four main problems including that the researchers at management level failed to report or report timely; the researchers reported in irregular filling;the same type of violation/deviation program happened repeatedly and the rectification to the review opinions of ethics committee was ineffective, and also put forward the corresponding suggestions, in order to strengthen and perfect the standard management of noncompliance/violation or protocol deviation report.

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica Idioma: Chinês Revista: Chinese Medical Ethics Ano de publicação: 2018 Tipo de documento: Artigo

Similares

MEDLINE

...
LILACS

LIS

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica Idioma: Chinês Revista: Chinese Medical Ethics Ano de publicação: 2018 Tipo de documento: Artigo