Protocol Development: A Contract Between Sponsor and Investigator

  • Rada Santosh Kumar GITAM Institute of Pharmacy, GITAM (Deemed to be University)
  • B. Joshna

Abstract

The main aim of this review which is published by the European Medicines Agency EMEA and the U.S. Food and Drug Administration (FDA)[1-7] is to describe about the importance of protocol in clinical trials.When developing a successful study designand writing a protocol, the researcher must address various successful components including the type of data being collected, data handling, record keeping, outcome measures. A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations and organization of clinical research project.

Downloads

Download data is not yet available.

Author Biography

B. Joshna

GITAM Institute of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam, 530045.

Statistics
162 Views | 120 Downloads
How to Cite
1.
Santosh Kumar R, Joshna B. Protocol Development: A Contract Between Sponsor and Investigator. JDDT [Internet]. 30Aug.2019 [cited 14Jun.2021];9(4-s):844-5. Available from: https://jddtonline.info/index.php/jddt/article/view/3398

Most read articles by the same author(s)

1 2 3 > >>