Home  |  About us  |  Editorial board  |  Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 78Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
OPINION
Year : 2017  |  Volume : 8  |  Issue : 4  |  Page : 162-166

International Council for Harmonisation E6(R2) addendum: Challenges of implementation


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
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_124_17

Rights and Permissions

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.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed406    
    Printed7    
    Emailed0    
    PDF Downloaded95    
    Comments [Add]    

Recommend this journal