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Safety reports

Serious unexpected suspected adverse reaction (SUSAR) reporting

 

Reporting of serious unexpected suspected adverse reactions (SUSARs) is conducted in accordance with the Directive 2001/20/EC and the Cabinet of Ministers Regulation No. 289 of 23 March 2010 “Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice”, as well as in accordance with the Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (“CT-3”) (2011/C 172/01).

Sponsors of clinical trials conducted in Latvia must submit all suspected unexpected serious adverse reactions (SUSARs) in the Eudravigilance Clinical Trials Module

SUSARs observed at clinical trials sites in Latvia must be reported in the Eudravigilance WEB TRADER (EVWB) section:

  • In the Clinical Trials Module of the State Agency of Medicines of Latvia with the message receiver identifier LRKPN2005
  • In the Eudravigilance Clinical Trials Module with the message receiver identifier EVCTMPROD

Sponsors of clinical trials conducted in Latvia must also report SUSARs observed outside of Latvia – this must be done in the Eudravigilance Clinical Trials Module with the message receiver identifier EVCTMPROD.

 

Contact information for communication regarding SUSAR reporting:

Elina Borherte

Phone: + 371 67078434

E-mail: elina.borherte@zva.gov.lv

 

Development Safety Update Report (DSUR)

During clinical research starting from the time of approval, the sponsor must submit a Development Safety Update Report (DSUR) to the State Agency of Medicines and ethics committee once a year and no later than 60 days after the end of the period of review laid down by the protocol. The report must include updated information regarding all of the serious unexpected suspected adverse reactions observed during the year, as well as a summary regarding safety of research subjects during the clinical trial. If the clinical trial duration does not exceed one year, the safety report may be submitted together with the clinical trial report upon completion of the trial.

The sponsor may submit the DSUR report to the State Agency of Medicines in an electronic format (e‑document, CD).