Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ ZENODOarrow_drop_down
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
ZENODO
Article . 2022
License: CC BY
Data sources: Datacite
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
ZENODO
Article . 2022
License: CC BY
Data sources: Datacite
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
ZENODO
Article . 2022
License: CC BY
Data sources: ZENODO
versions View all 2 versions
addClaim

GOOD CLINICAL PRACTICE IN PHARMACOVIGILANCE

Authors: Rajni Devi , Anjana Devi , Sanjay Kumar , Kamal Jeet , Tanuj Sharma , Sumanshu Sharma , Anjali Dhiman and Manish Kumar;

GOOD CLINICAL PRACTICE IN PHARMACOVIGILANCE

Abstract

Clinical research is a mechanism or a process that provides convincing evidence that the new treatments or therapies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of medicine. Good Clinical Practice (GCP) is an ethical and scientific quality standard for designs, operations and recordings involving the participation of human subjects. Accompanying the Guidelines pledges to the public that the ethics, integrity and welfare of humans participating in the trials are protected. India has experienced distinct opportunities for clinical trials for clinical trials compared to ethical patients, major medical institutions with fewer and more equipped investigators and fewer patient voices than regulated countries, with larger patient counts. However, our Indian guidelines were needed to ensure a uniform standard of clinical research across the country and to provide data for registration for new drugs before use in the human population in India. Junctions guidelines were developed by a complete committee set up by CDSCO with clinical experts. This article explains the importance of good clinical practice from an Indian clinical research perspective, while defining and outlining the goals and objectives of the GCP. It addresses the historical events that led to the emergence of good clinical practices and examines the current scenario with respect to the application of GCPs in clinical trials in India. Finally, the article addresses the challenges to maintaining a best and competitive system and will suggest a way forward to increase the credibility and efficiency of good clinical practice in clinical research.

Related Organizations
Keywords

Good Clinical Practices CDSCO Clinical Research Human Experimentation

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
    OpenAIRE UsageCounts
    Usage byUsageCounts
    visibility views 103
    download downloads 57
  • 103
    views
    57
    downloads
    Powered byOpenAIRE UsageCounts
Powered by OpenAIRE graph
Found an issue? Give us feedback
visibility
download
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
views
OpenAIRE UsageCountsViews provided by UsageCounts
downloads
OpenAIRE UsageCountsDownloads provided by UsageCounts
0
Average
Average
Average
103
57
Green