%0 Journal Article
%T International Council for Harmonisation E6(R2) addendum: Challenges of implementation
%A Arun Bhatt
%J Archive of "Perspectives in Clinical Research".
%D 2017
%R 10.4103/picr.PICR_124_17
%X The International Council for Harmonisation (ICH) E6 ¨C good clinical practice (GCP) (R2) addendum ¨C was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches ¨C quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders
%K Addendum
%K International Council for Harmonisation
%K investigator
%K regulatory
%K sponsor
%U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/