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Volume 7, Issue 5 (Suppl)

J Clin Trials, an open access journal

ISSN:2167-0870

Clinical Trials 2017

September 11-13, 2017

September 11-13, 2017 San Antonio, USA

4

th

International Conference on

Cl inical Tr ial s

Effective eCRF designing – Data management approach

Mohsin Shaikh

Axiom Real-Time Metrics, Canada

A

n effective eCRF design is always a key to the successful outcome of a clinical trial. The main objective is to offer improved

data quality, online discrepancy management, faster database lock and at the same to time preserve and maintain quality

and integrity of the data. eCRF design should be standardized to address the needs of all user roles enrolled within the clinical

trials. Data should be organized in a format that facilitates and simplifies data analysis for submission. Review of the primary and

secondary study end points as well as well-planned study design and safety/efficacy outcomes will assist the process of effective

eCRF designing. Use of CDISC standards variables will also enhance the process of effective eCRF building. Effective measures

taken while conducting eCRF design as well as post production changes (changes deployed on production environment of the

eCRF design) will result in reduced query generations and improved data integrity. This presentation will also describe the

methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Biography

Mohsin Shaikh has completed his MD from MS University, Gujarat and Post-graduate studies from AAPS Toronto. He is a lead Clinical Data Manager at Axiom

Real-Time Metrics, a premier clinical data management service organization providing expert solutions into the EDC/DM/IWRS sector. He has published more than

15 papers in reputed journals and has been serving as an Editorial Board Member of repute. He is an international medical graduate with more than eight years of

experience in clinical research industry mainly in clinical data management.

dr1mohsinshaikh@gmail.com

Mohsin Shaikh, J Clin Trials 2017, 7:5 (Suppl)

DOI: 10.4172/2167-0870-C1-019