Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 855Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
REVIEW ARTICLE
Year : 2019  |  Volume : 10  |  Issue : 2  |  Page : 57-61

Risk-based monitoring: Review of the current perceptions and toward effective implementation


CEO, Medicines n We, Clinical Research and Healthcare Consultant, Mumbai, Maharashtra, India

Correspondence Address:
Dr. Veena Shridhar Jaguste
A/113, Oshiwara Industrial Centre, New Link Road, Goregaon West, Mumbai - 400 104, Maharashtra
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_18_18

Rights and Permissions

The United States Food and Drug Administration issued a guidance to industry in August 2013 on risk-based approach to monitoring. This prompted industry (sponsors and contract research organizations) to brainstorm, conceptualize, and implement risk-based monitoring (RBM) in their clinical studies and programs. The acceptance and implementation across the organizations have been variable in terms of pace and methodology. Published literature, commentaries, and views through Internet search were reviewed to understand the perceptions about RBM of different key stakeholders whose function has been significantly impacted, as these highlight ground-level challenges while implementing this major change. Some solutions are proposed to address these perceptions and challenges, as sooner than later RBM will become a way of life, given that recent ICH E6, revision 2 (November 2016) includes RBM in the document. Conceptual clarity, change management, skillset, and capacity building will be the key areas of focus to make RBM successful.


[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
    Viewed550    
    Printed36    
    Emailed0    
    PDF Downloaded132    
    Comments [Add]    

Recommend this journal