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Updated: Apr 10, 2026

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
Status of documentation grading and completeness score for Indian individual case safety reports
Kalaiselvan Vivekanandan1, Kumar Rishi1, Thota Prasad1
1Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
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.
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