Suspected unexpected serious adverse reaction

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance—Clinical Trial Module). April 2003. ENTR 6101/02... 

All relevant information on suspected unexpected serious adverse reactions (SARs) considered life threatening or fatal must be reported to CA in all MS and to the IEC as soon as possible or within 7 days of the sponsor learning of them and all follow-up information within a further 8 days. All other reactions are to be advised within 15 days of knowledge by the sponsor. Member States are responsible for recording all SARs and sponsors for advising all investigators. 

SUSAR suspected unexpected serious adverse reaction (Eudravigilance CT module)... 

Regulation (EC) No 540/95. Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human... 

Reporting to member states and the Agency within 15 days of all suspected serious unexpected adverse reactions occurring in Third World countries. 

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) within eight calendar days if they were fatal or life threatening, and within fifteen days for other serious cases. The initial report has to be followed up within seven days for fatal or life-threatening cases and within fifteen days for other serious reports. These expedited reporting requirements mean that the treatment code in blinded trials must be broken, as it is otherwise impossible to decide which treatment the patient received and, therefore, impossible to determine whether an event could possibly be a reaction if a patient received placebo, then there is no suspicion of a possible adverse reaction to the IMP and authorities do not require expedited... 

Regulation 540/95 arrangements for reporting suspected unexpected adverse reactions which are not serious. 

For medicines introduced recently - as indicated by an inverted black triangle (T) in the product entry in the British National Eormulary, MIMS and the ABPI Data Sheet Compendium - doctors and hospital pharmacists are asked to report all suspected reactions. This includes any adverse or any unexpected event, however minor, which could conceivably be attributed to the medicine. Reports should be made despite uncertainty about a cause or relationship, irrespective of whether or not the reaction is well recognised and even when other medicines have been taken concurrently. (The legal position for the pharmaceutical industry requires the reporting of aU serious ADRs from the UK or other EU countries, and of all serious and unexpected ADRs from coimtries outside the EU). 

SUSAR Serious unexpected suspected adverse drug reaction ... 

CIOMS IV form for reporting of serious unexpected suspected adverse drug reactions www.cioms.ch. ABPI Code of Practice 2003. 

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