Tender for Competition no.6: Methods and data sources for determining long-term effects of drug exposure during pregnancy, with application to antiepileptic medicines. EUROmediSAFE Consortium

Study identification

• EU PAS number:
  EUPAS21171
• Study ID:
  27936
• Official title and acronym:
  Tender for Competition no.6: Methods and data sources for determining long-term effects of drug exposure during pregnancy, with application to antiepileptic medicines. EUROmediSAFE Consortium
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will seek to compile an inventory of available data sources in all 28 European Union Member States for potential use when evaluating the long-term risks of for children associated with in-utero exposure.
• Study status:
  Finalised

Research institutions and networks

Institutions

Queen Mary University of London

Study timelines

Date when funding contract was signed

Actual:15/12/2016

Study start date

Planned:18/04/2016

Actual:23/05/2017

Data analysis start date

Planned:09/11/2017

Actual:09/11/2017

Date of interim report, if expected

Actual:04/05/2018

Date of final study report

Planned:09/05/2018

Actual:06/07/2018

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable