Adverse drug reactions notification

Notification by sponsor and/or investigator, where applicable to regulatory authorities and IRBs/IECs of unexpected serious adverse drug reactions and other safety information... 

Responsibility and procedure for notification of Adverse Drug Reactions (ADRs) or other unexpected or unusual occurrences in compliance with the legislation needs to be described. 

Smith, C.C., Bennett, P.M., Pearce, H.M., Harrison, P.I., Reynolds, D.J., Aronson, J.K. and Grahame-Smith, D.G. (1996) Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines. British Journal of Clinical Pharmacology, 42, 423—429. 

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