| OPINION |
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| Year : 2017 | Volume
: 8
| Issue : 4 | Page : 162-166 |
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International Council for Harmonisation E6(R2) addendum: Challenges of implementation
Arun Bhatt
Consultant – Clinical Research and Development, Mumbai, Maharashtra, India
Correspondence Address:
Arun Bhatt
303/304, 3/C, Dheeraj Valley, Mohan Gokhale Road, Behind Sai Baba Complex Goregaon (East), Mumbai 00 063, Maharashtra
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/picr.PICR_124_17
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The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – 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.
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