Status of documentation grading and completeness score for Indian individual case safety reports.

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  • Additional Information
    • Source:
      Publisher: Medknow Publications Country of Publication: India NLM ID: 7902477 Publication Model: Print Cited Medium: Internet ISSN: 1998-3751 (Electronic) Linking ISSN: 02537613 NLM ISO Abbreviation: Indian J Pharmacol Subsets: MEDLINE
    • Publication Information:
      Publication: Mumbai : Medknow Publications
      Original Publication: Pondicherry, Published for the Indian Pharmacological Society by the Dept. of Pharmacology, Jawaharial Institute of Postgraduate Medical Education and Research, [1969?]-
    • Subject Terms:
    • Abstract:
      The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.
    • References:
      Lancet. 2000 Oct 7;356(9237):1255-9. (PMID: 11072960)
      Drug Saf. 2014 Sep;37(9):703-10. (PMID: 25085041)
      Drug Saf. 2014 Jan;37(1):65-77. (PMID: 24343765)
    • Contributed Indexing:
      Keywords: Completeness score; Pharmacovigilance Programme of India; Uppsala Monitoring Centre; individual case safety reports
    • Publication Date:
      Date Created: 20150613 Date Completed: 20160509 Latest Revision: 20220318
    • Publication Date:
      20221213
    • Accession Number:
      PMC4450561
    • Accession Number:
      10.4103/0253-7613.157133
    • Accession Number:
      26069373