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. 2015 May-Jun;47(3):325-7.
doi: 10.4103/0253-7613.157133.

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

Kalaiselvan Vivekanandan  1 , Kumar Rishi  1 , Thota Prasad  1 , Tripathi Arunabh  1 , G N Singh  1
Affiliations

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

Kalaiselvan Vivekanandan et al. Indian J Pharmacol. 2015 May-Jun.

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.

Keywords: Completeness score; Pharmacovigilance Programme of India; Uppsala Monitoring Centre; individual case safety reports.

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Conflict of interest statement

Conflict of Interest: No.

Figures

Figure 1
Figure 1
Completeness score progress in each quarter of year 2011–2014
See this image and copyright information in PMC

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