Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 597Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
QUALITY
Year : 2011  |  Volume : 2  |  Issue : 2  |  Page : 54-58

Strategies for ensuring quality data from Indian investigational sites


1 Managing Director, Procelsis Consulting, Germany
2 Associate Partner Asia-Pacific, Procelsis Consulting, Germany

Correspondence Address:
Antal K Hajos
Am Farnberg 3, 79289 Horben
Germany
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.80367

Rights and Permissions

The topic of ensuring quality and compliance is and must be a top priority in the conduct of clinical trials, as warranted by regulatory guidelines as well as the inherent responsibility of the professionals conducting such research. Fast-growing emerging clinical geographies such as India demand special attention due to rapid growth and associated factors that may put study quality at risk. In this paper, we used the basic principle of PDCA (Plan, Do, Check, and Adjust) to structure the processes of a clinical trial from protocol to final analysis in order to highlight the interactive nature of involved people and processes required to ensure quality of data and site functioning.


[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
    Viewed2296    
    Printed150    
    Emailed1    
    PDF Downloaded381    
    Comments [Add]    

Recommend this journal