New discussion: PhV in medical research - XXVII

[Guest guest]

Dear members,Few words about ICSR - INDIVIDUAL CASE SAFETY REPORTSIndividual case safety reports of adverse drug reactions and adverse events need to be transmitted− from identified reporting sources to regulatory authorities and pharmaceutical companies;− between regulatory authorities;− between pharmaceutical companies and regulatory authorities;− within authorities or pharmaceutical companies;− from clinical investigators, via the sponsor, to ethics committees;− from authorities to the World Health Organization (WHO) Collaborating Center

for International Drug Monitoring.Find attached the guideline for data elements for transmission of individual case safety reports.Regards,Dr. Vijay M. KatekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060

1 of 1 File(s)

E2B ICSR Data elemrnts.pdf