Feasibility Analysis: The First Crucial Phase of Startup in Clinical Research

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DOI: 10.21522/TIJCR.2014.03.01.Art006

Authors : Vinod Gyanchandani, Pradnya Mahatme, Ashok Motwani


This review article presents the standard requirements and processes for activities which need attention during the collection of a Confidentiality agreement (CDA)/ Non-Disclosure Agreement (NDA) & Feasibility analysis from a potential investigator during the startup phase of the study. This article presents the roles and responsibilities of participants, and the importance of communication and flexibility during this phase of a study. This article is written in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (ICH GCP Topic E6).

Keywords: Start-up, data, Protocol, Sponsor, Investigator, Site, Synopsis


  1. Andrea G. Procaccino. Managing Clinical Trials. New Drug Approval Process; Fourth Edition; 523-526

  2. Carol Opalek & Joy Frestedt. 2009. Study Startup 101. The Monitor; Page 51 -55

  3. Fundamentals of Clinical Research; SSV; Unit 5; Page 141

  4. Dr. Julka. P. K. Becoming a Successful Clinical Trial Investigator; Introduction to Clinical Research;, Page 1

  5. Karen E. Woodin. Coordinating Clinical Research; The Clinical Research Coordinator; Page 3-4’ 91-95

  6. Karen E. Woodin & John C. Schneider. Monitoring Clinical Research; Second Edition; Page 106-111.