title: Status of documentation grading and completeness score for Indian individual case safety reports.
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.
authors.affiliation: Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
authors.forename: Kalaiselvan
authors.initials: K
authors.lastname: Vivekanandan
authors.affiliation: Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
authors.forename: Kumar
authors.initials: K
authors.lastname: Rishi
authors.affiliation: Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
authors.forename: Thota
authors.initials: T
authors.lastname: Prasad
authors.affiliation: Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
authors.forename: Tripathi
authors.initials: T
authors.lastname: Arunabh
authors.affiliation: Pharmacovigilance Division, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghazibad, Uttar Pradesh, India.
authors.forename: G N
authors.initials: GN
authors.lastname: Singh
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D004282:Documentation / Q000379:methods* / Q000592:standards*; D006801:Humans; D007194:India; D060735:Pharmacovigilance; D011786:Quality Control; D014944:World Health Organization
keywords: Completeness score; Pharmacovigilance Programme of India; Uppsala Monitoring Centre; individual case safety reports