BRINGING YOU INFORMATION.  PROVIDING YOU A PLATFORM.

 

 
THE PHARMA REVIEW (MARCH - APRIL 2017)

Data Integrity in Clinical Trails

*Balamuralidhara V., Lakshmi Triveni. Kolla & T.M. Pramod Kumar

Introduction: The process of attaining and maintaining data integrity is critical to ensure a successful clinical trail. Data integrity is a fundamental component of information security in its broadest use, data integrity refers to the accuracy and consistency of data stored in the data base, warehouse, data mart or other construct. The development of time saving process that safeguard data integrity continues to be a primary goal of pharmaceutical companies. The main objective of the study is a) impact of data integrity in clinical trails. b) Challenges are faced by the agencies. Additional timesaving process evolved processes during the 1990s via the advent of the internet. Today, electronic methods allow high integrity data collection. In the current study, we were able to demonstrate that data entered on electronic case report forms accurately matched data entered on paper forms thus providing qualification of data integrity .The process of achieving data integrity involves developing protocols in three key areas: data collection, training of data collectors and data monitoring. The use of these protocols will increase the rigor of the clinical trail and assist in maintaining study validity. Based on this review it can be concluded that clinical trail investigators conducting clinical trail need to consider all issues involved in achieving data integrity and have tested protocols in place throughout the study. These methods will not only help maintain study validity but also help ensure data of sufficient quality and quantity to achieve the desired statistical power. 

 

Go to Content Index Page

PHARMA REVIEW - ARTICLES ARCHIVE ( COMPLETE LIST)

 

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 26855839, 9811195411
Email: kongposhpub@gmail.com, Website: http://www.kppub.com

 
 
 
 

Copyright KONGPOSH PUBLICATIONS Pvt. Ltd.