Protocol Development: A Contract Between Sponsor and Investigator

Authors

  • 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.

DOI

https://doi.org/10.22270/jddt.v9i4-s.3398

Author Biography

B. Joshna

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

Published

30-08-2019
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How to Cite

1.
Santosh Kumar R, Joshna B. Protocol Development: A Contract Between Sponsor and Investigator. J. Drug Delivery Ther. [Internet]. 2019 Aug. 30 [cited 2025 Feb. 12];9(4-s):844-5. Available from: https://jddtonline.info/index.php/jddt/article/view/3398

How to Cite

1.
Santosh Kumar R, Joshna B. Protocol Development: A Contract Between Sponsor and Investigator. J. Drug Delivery Ther. [Internet]. 2019 Aug. 30 [cited 2025 Feb. 12];9(4-s):844-5. Available from: https://jddtonline.info/index.php/jddt/article/view/3398

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